A Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of HFPM-01 in Improving Pain, Stiffness, and Inflammation in ...
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International Journal of Research and Review
DOI: https://doi.org/10.52403/ijrr.20210401
Vol.8; Issue: 4; April 2021
Website: www.ijrrjournal.com
Original Research Article E-ISSN: 2349-9788; P-ISSN: 2454-2237
A Randomized, Placebo Controlled Clinical Trial to
Evaluate the Efficacy and Safety of HFPM-01 in
Improving Pain, Stiffness, and Inflammation in
Patients Suffering from Knee Osteoarthritis
Veena Deo1, Bharatbhushan Shrikhande2, Gayatri Ganu3, Umesh Gajare4
1
Head Clinical Research, Siddhayu Ayurvedic Research Foundation Pvt. Ltd, Nagpur, Maharashtra, India
2
Siddhayu Ayurvedic Research Foundation Pvt. Ltd, Nagpur, Maharashtra, India
3
Mprex Healthcare, Wakad, Pune, Maharashtra, India
4
Consultant, Global Hospital, Kalewadi phata, Wakad, Pune Maharashtra, India
Corresponding Author: Gayatri Ganu
ABSTRACT reduction in GI symptoms were found to be
33%, 308%, 60.44%, 52%, 40% respectively.
Objective: Osteoarthritis is a common chronic Swelling, inflammation and pain was reduced
joint condition which causes stiffness and from moderated to mild and eventually to no
difficulty in moving, loss of muscle tone, symptoms.
strength and stamina. All these difficulties affect Conclusion: This explains that HFPM-01 tablet
daily activities and quality of life and may also is significantly effective in improving SF36
have an impact of mental health. Globally over score WOMAC and VAS scale score. It is
9.6% men and 18.0% women aged over 60 effective in reducing pain, swelling, and
years has symptomatic osteoarthritis worldwide. stiffness of knee joints, also improves the
It is the second most common rheumatologic mobility of knee joints, and provides gastro
problem and it is the most frequent joint disease protection being effective in managing pain and
with a prevalence of 22% to 39% in India. stiffness. HFPM-01tablet is safe and effective in
Considering the increasing prevalence and the management of Osteoarthritis.
limitations of the conventional treatment for the
management of Osteoarthritis, the current Key words: Osteoarthritis, WOMAC, VAS,
research aims at systematic clinical validation of CRP, Gastro protective
the HFPM-01 in subjects primarily suffering
from knee osteoarthritis. INTRODUCTION
Materials and Methods: 90 subjects were Osteoarthritis is a common and
enrolled in the study and were randomized to disabling condition that represents a
one of the three treatment groups. Subjects were substantial and increasing health burden
undergoing clinical examination. Vitals were
with notable implications for the individuals
recorded. Blood samples were collected for
readings of CRP. Subjective questionnaire affected, health-care systems, and wider
scores evaluation was performed like SF-36 socioeconomic costs [1]. The prevalence of
health survey score, VAS scale, WOMAC the population associated with aging and
questionnaire. Changes in symptoms severity increasing obesity along with a growing
were noted like morning stiffness, tiredness, number of joint injuries is becoming more
tenderness, and muscle spasms along with common, with worldwide estimates
assessment of GI symptoms. suggesting that 250 million people are
Results: The change in WOMAC score, the currently affected [2]. Osteoarthritis (OA) is
increase in SF-36 score, the decrease in VAS the most common type of arthritis in both
score, the decrease in CRP levels, and the developed and developing countries. It is a
International Journal of Research and Review (ijrrjournal.com) 1
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
chronic, progressive musculoskeletal for patients who do not respond well to
disorder characterized by gradual loss of conventional medical therapy. Such patients
cartilage in joints which results in bones are turning increasingly to natural product
rubbing together and creating stiffness, pain, medicines [8].
and impaired movement. The disease most With understanding the limitations
commonly affects the joints in the knees, of the conventional treatment for the
hips, hands, feet, and spine. The disease is management of OA, and Phytoconstituents
associated with modifiable and non- known to play a major role in the
modifiable risk factors such as obesity, lack management of arthritis, Siddhayu
of exercise, genetic predisposition, bone Ayurvedic Research Fdn. Pvt. Ltd. has
density, occupational injury, trauma, and come up with a polyherbal formulation
gender [3]. Osteoarthritis can be categorized conceptualized to be safe and effective in
into two groups primary and secondary. the management of the osteoarthritis. The
Primary osteoarthritis is a chronic product under the selection of composition
degenerative disease and is related to aging holds the potential to be effective in not
while secondary arthritis usually occurs due only managing pain and inflammation but
to secondary factors such as injury, diabetes, also trying to treat the root cause and
and obesity [4]. According to World Health improve the quality of life of subjects with
Organization (WHO), 9.6% of men and osteoarthritis. This research aims at
18.0% of women aged over 60 years has systematic clinical validation of the same in
symptomatic osteoarthritis worldwide. subjects primarily suffering from knee
Osteoarthritis is the most common osteoarthritis.
rheumatologic problem and it is the most
frequent joint disease with a prevalence of MATERIAL AND METHODS
22% to 39% in India. Pharmacological Materials
interventions include non-opioid analgesics HFPM-01 Formulation was used for
such as paracetamol, non-steroidal anti- the study as an investigational product. It
inflammatory drugs (NSAIDs), topical consists of Boswellia serrata, Zingiber
analgesics, opioid analgesics, and intra- officinale, Withania somnifera, Curcuma
articular steroid injection [5]. Additional longa, Pluchea lanceolata as key
complementary interventions employed for ingredients out of total 9 ingredients. The
OA include the use of physiotherapy and dose of HFPM-01 was 1 tablet thrice a day
antidepressant therapies, patient education, after meals with water for 90 days.
and weight control [6]. These treatments may
prove ineffective in some patients and often Methods
[7]
have serious adverse effects . After getting approval from the
Gastrointestinal complications are ethics committee, the study was registered
frequently reported with NSAIDs. The on the CTRI website. The CTRI registration
conventional medications possess limitation number is CTRI/2020/07/026655. Patients
of providing symptomatic relief for transient were enrolled in the study only after
period not acting on the deeper reasons of registration of study on the CTRI website.
inflammation, oxidative stress and The subjects were recruited after screening
degenerative metabolic changes. Overall for compatibility with inclusion and
quality of life of subjects becomes exclusion criteria. Total 90 subjects were
compromised though on the analgesic recruited and were grouped as 30 subjects in
medication. Hence there seems to be a each group. Group 1 was served with
requirement for drugs with good efficacy HFPM-01, in prescribed dosage group 2
with overall improvement in quality of life was control group received only analgesics
of subjects suffering from OA. Specifically, as and when required and group 3 was
there is a need for safe and effective drugs
International Journal of Research and Review (ijrrjournal.com) 2
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
treated with Glucosamine 500 mg thrice osteoarthritis of any other joint except knee
daily. and ones with a history of major trauma or
The primary objectives of the study surgery in the knee joint were exempted
were to evaluate the safety and efficacy of from the study. Patients with uncontrolled
HFPM-01 by assessing changes in diabetes and hypertension were not
performance of patient on pain VAS and the considered. Patients with Body mass index
WOMAC scale, to monitor the (BMI) >40 kg/m2 and with any severe
improvement in SF-36 health survey score. cardiac, renal, and hepatic disease were
We evaluated degree symptomatic relief excluded. Vulnerable population and
including pain, inflammation, stiffness, patients who had participated in any clinical
swelling, joint flexibility, weight-bearing trial within 30 days before enrollment were
capacity, levels of inflammatory mediator not considered for the study. Patients that
like CRP in blood. We determined the found unfit from the view point of
proportion of subjects requiring analgesics investigator were excluded from the study.
as rescue medication, gastrointestinal
symptoms due to treatment, like stomach Study procedure
pain, heartburn, vomiting, nausea, After the ethics committee’s
constipation/ diarrhea, etc. approval, the clinical study was registered
The secondary objectives of the on the CTRI website. Male and female
study were to evaluate tolerability of study subjects of age between 40 to 60 years (both
drug by tracking adverse events, serious inclusive) attending the study site(s) were
adverse events during the study period, pain screened for eligibility criteria. On the
status, and improvement in symptoms for screening visit, written informed consent
other than knee pain if any (Shoulder, was obtained from subjects for their
backache and muscle spasms). participation in the study. Subjects were
undergoing clinical examination Subject’s
Inclusion Criteria vitals were recorded. The subject was
Patients of either sex, 40 to 70 years considered for further evaluation as per the
of age and diagnosed with OA of knees inclusion and exclusion criteria. Subjects
fulfilling the ACR classification criteria were called the next day morning on empty
were included in the study. The patients stomach for laboratory testing. The subject’s
having minimum pain VAS score > 8 on blood samples were collected for laboratory
walking in one or both knees during the 24 testing. On baseline visit, the subject was
hours preceding recruitment were recruited in the study if he or she meets all
considered to be included in the study. The the inclusion criteria. As per the computer-
patients may or may not receiving regular generated randomization, subjects were
anti-inflammatory or analgesic drugs or randomized in one of the three groups.
ones who were not satisfied with drugs Clinical examination and the subject’s vitals
being taken and seek a change were were recorded. All the subjective
included in the study. Patients who were questionnaire scores were filled like SF-36
willing to come for regular follow up visits Health Survey score, VAS scale, WOMAC
and agreeing to give written informed questionnaire. At baseline visit and every
consent were considered. follow-up visit. Subjects were advised to
consume the given product in a prescribed
Exclusion Criteria dosage. Subjects were advised to continue
Patients with congenital arthropathy, her/ his concomitant medication other than
rheumatoid arthritis, active gout, other types antioxidant agents, weight loss
of arthritis with/without inflammation were management, vitamins, anti-inflammatory
excluded from the study. Patients with a drugs, hormones, nutraceuticals, Ayurveda,
known history of coagulopathies, Siddha, Unani, herbal /homeopathic
International Journal of Research and Review (ijrrjournal.com) 3
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
medicines, etc. The record of concomitant RESULTS
medication was kept in the CRF. The DEMOGRAPHIC DETAILS
NSAID agents were not allowed in the test In the present study, 115 subjects
and glucosamine treatment group except as were screened. 10 subjects were screened
a rescue medication for pain. The record of for failure as per the decision of the
the same was also documented in CRF. investigator as were having to present
Drug compliance was assessed by the uncontrolled diabetes. Out of 105 subjects,
investigator on every follow-up visit. 15 lost to follow up in the study. 90 subjects
Subjects who continuously missed dosing were considered evaluable cases at the end
for >3 consecutive days or total missed dose of the study. Out of 90 completed subjects,
> 9 during the study period were treated as the mean age of HFPM-01 group subjects
dropouts. Subjects were called to respective was 48.5 ± 5.75 years and the mean age of
study sites for follow-up visits after every glucosamine and control group subjects
month up to 3 months after the baseline were 49.2 ± 6.06 and 46.7 ± 5.3 years
visit. On every follow-up visit, Subjects respectively. There were an equal number of
were undergoing clinical examination. The male and female subjects i.e., 15 males and
subject’s vitals were recorded. All the 15 females in each group.
subjective questionnaire scores and
symptom gradation were recorded in CRF. CHANGES IN WOMAC SCORE
Subjects were critically examined for In HFPM-01 group % change in the
adverse events. All details were recorded in WOMAC score from day 0 to day 90 was
the CRF along with the rescue medication if 33 % and in the glucosamine group percent
present. On the third follow-up visit (i.e., change was 39 %. On the other hand,
Day 90) following activities were done control group represented a very less %
Subject was undergoing clinical change in the WOMAC score of 3.4 %.
examination. The subject’s vitals were When compared between groups the
recorded. Blood samples were collected for HFPM-01 group and glucosamine group
readings. All the subjective questionnaire represent a comparable reduction in
scores were filled like SF-36 health survey WOMAC score from day 0 to day 90 as
score, VAS scale, WOMAC questionnaire. compared to the control group. The results
Subjects were scored on their symptoms like are shown in Graph 1.
morning stiffness, tiredness, tenderness, and
muscle spasms. Subjects were asked about
GI symptoms. After completion of 3 months
of study treatment, all the subjects were
asked to stop trial medications and take the
advice of the investigator for further
treatment. All the subjects were closely
monitored for any adverse event starting
from baseline visit till the end of the study
visit.
STATISTICS
Sample size consideration
Sample size calculation is derived
taking considerations of primary and Graph No. 1: Changes in WOMAC score from baseline to end
of the study
secondary outcomes by a qualified
statistician. The software used for the
CHANGES IN SF 36 SCORE
calculation of sample size is SPSS version
In HFPM-01 group represent an
10.0
increase in % change in SF-36 score from
International Journal of Research and Review (ijrrjournal.com) 4
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
day 0 to day 90 was 308 % and in the significant change in VAS score by HFPM-
glucosamine group % change was 195 %. 01 and glucosamine treatment when
On the other hand, control group compared with the control group. The
represented 51 %. When compared between results are depicted in Graph 3.
groups the HFPM-01 group presented
significant increase in SF 36 score
compared to the glucosamine group as well
as the control group. The results are
depicted in Graph 2.
Graph No.3: Changes in VAS score from baseline to end of the
study
CHANGES IN CRP LEVEL
There were increased CRP levels in
Graph No. 2: Changes in SF 36 score from baseline to end of
all three groups on the baseline. There was a
the study decrease in CRP levels after treatment of
HFPM-01 and Glucosamine. The percent
CHANGES IN VAS SCORE decrease observed in HFPM-01 and
HFPM-01 and glucosamine Glucosamine treated groups were 52 and
treatment represented a decrease in VAS 36% respectively. The control group didn’t
score from baseline to end of the study. The decrease the CRP levels from baseline to
% decrease was 60.44% and 58.43% in end of the study. The results are depicted in
HFPM-01 and glucosamine treatment group Table no. 4.
respectively whereas in the control group
the % decrease was around 7%. There was a
Table no.4: Changes in CRP level in Glucosamine, HFPM-01 treated and control groups from baseline to end of the study:
Groups Change in CRP level (mg/L) Mean ± SD
Baseline Day 90 % Change P-Value
HFPM-01 5.15 ± 6.68 2.47 ± 1.80 52 0.0193
Control 5.46 ± 5.61 5.39 ± 4.42 1.3 0.8270
Glucosamine 5.12 ± 3.86 3.26 ± 2.76 36 0.0001
P-Value control vs. HFPM-01 0.8422 0.032
P-Value Glucosamine vs. HFPM-01 0.9855 0.1953
Between-group analysis by one-way ANOVA test, within-group analysis by paired t-test, Significant at P≤0.05
CHANGES IN SEVERITY OF day 90. In the glucosamine treatment group
SYMPTOMS 14 subjects presenting heartburn symptoms
Changes in frequency of subjects on the baseline which reduced by 21.4 %
experiencing heartburn from baseline to day 90. In the control
In the present study the HFPM-01 treatment group 13 subjects presenting
test group 12 subjects suffering from GI heartburn symptoms on the baseline which
symptoms like heartburn on the baseline reduced by 7.7 % from baseline to day 90.
which reduced by 66.7 % from baseline to HFPM-01 treatment has the potential to
International Journal of Research and Review (ijrrjournal.com) 5
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
provide relief from GI-related symptoms Changes in frequency of subjects
like heartburn in comparison to the according to severity score for tiredness
glucosamine and control treatment group. On the baseline, 70% and 30% of
subjects from the HFPM-01 treatment group
Changes in frequency of subjects reported moderate to severe tiredness which
experiencing constipation was comparable to 66.6 and 33.3% in the
In HFPM-01 test group 10 subjects glucosamine treated group. In the control
suffering from GI symptoms like group 33% of subjects reported moderate
constipation on the baseline which reduced and the rest 66% reported severe tiredness.
by 40 % from baseline to day 90. In the On day 90 similar proportion of subjects
glucosamine treatment group 13 subjects from the control group were representing
suffering from constipation on the baseline moderate and severe tiredness. In the
which was reduced by 23.1 % from baseline glucosamine and HFPM-01 treatment
to day 90. In the control treatment group 12 group, there was a gradual shift in subjects
subjects presenting constipation symptoms representing tiredness from moderate to
on the baseline which reduced by 8.3 % mild and eventually no symptoms. There
from baseline to day 90. HFPM-01 were 4 subjects from HFPM-01 treatment
treatment has the potential to provide relief group who reported no tiredness and no
from GI-related symptoms like constipation subject in the glucosamine treatment group
in comparison to the glucosamine and reported no tiredness.
control treatment group. It is evident from results that both
glucosamine and HFPM-01 treatment group
Changes in frequency of subjects showed effectiveness in relieving tiredness
according to severity score for morning of patients but HFPM-01 showed better
stiffness activity than glucosamine.
On baseline 56.7 and 43.35 subjects
from HFPM-01 treatment group reported Changes in frequency of subjects
moderate to severe morning stiffness which according to severity score for Muscle
was comparable to 63.3 and 36.6 in spasms
glucosamine treated group. In the control On baseline subjects from HFPM-
group 50% of subjects reported moderate 01, glucosamine and control treatment
and the rest 50% reported severe morning group reported moderate to severe muscle
stiffness. On day 90, similar proportion of spasms which were comparable. On day 90
subjects from the control group were similar proportion of subjects from the
representing moderate and severe morning control group were representing moderate
stiffness. In the glucosamine and HFPM-01 and severe muscle spasms indicating no
treatment group, there was a gradual shift in relief. In the glucosamine and HFPM-01
subjects representing morning stiffness from treatment group, there was a gradual shift in
moderate to mild and eventually no subjects representing muscle spasms from
symptoms. There were 10 subjects from moderate to mild and eventually no
HFPM-01 treatment group who reported no symptoms. There were 10 subjects from
morning stiffness and around 3% in the HFPM-01 treatment group who reported no
glucosamine treatment group reported no muscle spasms and around 5 in the
morning symptoms. It is evident from glucosamine treatment group reported no
results that both glucosamine and HFPM-01 muscle spasms. It is evident from results
treatment group showed effectiveness in that both glucosamine and HFPM-01
relieving morning stiffness of patients but treatment group showed effectiveness in
HFPM-01 showed better activity than relieving muscle spasms of patients but
glucosamine. HFPM-01 showed better activity than
glucosamine.
International Journal of Research and Review (ijrrjournal.com) 6
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
Changes in frequency of subjects The weight-bearing capacity of
according to severity score for subjects was significantly improved in the
Inflammation and Swelling glucosamine and HFPM-01 treatment group
On baseline subjects from HFPM- compared to the control group.
01, glucosamine and control treatment
group reported moderate to severe DISCUSSION
inflammation and swelling which was Osteoarthritis condition is involving
comparable. On day 90 similar proportion mediators of intra- and extracellular pro-
of subjects from the control group were inflammatory cytokines, interleukin-1β (IL-
representing moderate and severe 1β) and tumor necrosis factor-α (TNF-α),
inflammation and swelling indicating no e.g., nuclear factor Kappa-B (NF-kB), pro-
relief. In the glucosamine and HFPM-01 inflammatory enzyme cyclooxygenase-2
treatment group, there was a gradual shift in (COX-2). The inflammatory activity
subjects representing inflammation and precipitates in development of pain and
swelling from moderate to mild and related to function disability which can be
eventually no symptoms. It is evident from evaluated by using The Western Ontario and
results that both glucosamine and HFPM-01 McMaster Universities Arthritis Index
treatment group showed effectiveness in (WOMAC) which is commonly used
relieving inflammation and swelling of outcome measure for osteoarthritis. It is a
patients equally or comparably. validated and widely used instrument for
assessing parameters like knee and hip pain,
Changes in frequency of subjects stiffness and physical function. [9]
according to severity score for joint WOMAC combined score is the sum
flexibility of the pain sub score, stiffness sub score and
On baseline subjects from HFPM- physical function sub score assessed on
01, glucosamine and control treatment WOMAC Index. [10]
group reported moderate to severe difficulty Treatment with HFPM-01
in joint flexibility which was comparable. significantly reduced the WOMAC score
On day 90 similar proportion of subjects from baseline to end of the study.
from the control group were representing Curcumin, Boswellia serrata, Bioperine and
moderate and severe difficulties in joint Ginger from HFPM-01 formulation may
flexibility indicating no relief. In the have contributed in improvement in joint
glucosamine and HFPM-01 treatment flexibility and reduction in pain evident by
group, there was a gradual shift in subjects WOMAC score. These herbs are proven
representing difficulty in joint flexibility anti-inflammatory in action. Curcumin,
from moderate to mild and eventually no ginger is preventing collagen degradation
symptoms. There were 8 subjects from and inhibition of pro-inflammatory
HFPM-01 treatment group who reported no mediators such as prostaglandins, COX,
difficulty in joint flexibility and around 3 in nitric oxide and NF-kB and down-regulation
the glucosamine treatment group reported of the pro-inflammatory cascade evident by
no difficulty in joint flexibility. It is evident many researches already published. [11]
from results that both glucosamine and CRP is activator in promotion of
HFPM-01 treatment group showed pro-inflammatory cytokines, which
effectiveness in relieving difficulty in joint increases the inflammatory response. There
flexibility of patients but HFPM-01 showed are many studies represents the connection
better activity than glucosamine. between elevated CRP levels in OA which
is was significantly associated with pain and
Changes in frequency of subjects decreased physical function. [12,13]
according to severity score for weight- In this study CRP is evaluated as
bearing capacity inflammatory marker which may act as
International Journal of Research and Review (ijrrjournal.com) 7
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
contributing factor in disease progression in activity confirmed through other clinical
patients with OA. [13] In the present study, trials as well. Nirgundi from HFPM-01
there were increased CRP levels in all three possess pain-suppressing activities, possibly
groups on baseline. There was significant mediated via inhibition of prostaglandin
decrease in CRP levels after treatment of synthesis. The possible role of anti-oxidant
HFPM-01. Decrease in CRP levels in activity of W. somnifera on its anti-
patients belong to HFPM-01 treatment inflammatory properties has been already
group shown possible mechanism Z. reported. Many experimental results have
officinale extract as an anti-inflammatory shown that W. somnifera improved VAS
activity by reducing serum level of TNF-α score by improving pain response,
and high-sensitivity C-reactive protein (hs- antioxidant status and general wellbeing
CRP). [14] [18,19]
Quality of life of recruited subjects Drug therapies like non-opioid
was assessed using SF-36 questionnaire analgesics and non-steroidal anti-
along with general health and energy status. inflammatory drugs (NSAIDs) in
SF-36 Health Survey (SF-36) scale scores management of OA can develop
also describe the health burden of arthritis gastrointestinal complications. HFPM-01
and to be responsive to clinical indicators of possesses such ingredients which are gastro
arthritis severity. [15] These parameters protective in nature and hence evaluated for
altogether were considered to reflect the its effectiveness in this several number
overall quality of life of the individual drugs related GI complication present in
suffering from OA. patients with OA.
From present study it was evident The present data represent that herbs
that the control group did not improve like turmeric, chopchini extract (Bark) and
quality of life but HFPM-01 improved QoL ginger used in HFPM-01 formulation have
score by three folds compared to baseline. its promising effect on GI related
Shallaki (Boswellia serrata) mainly complications like nausea, hyperacidity,
have its activity on lipoxygenase pathway. heartburn and constipation etc. [20] The
Combination of Sunth (Zingiber officinale), absence of gastric disturbance and improved
and Shallaki (Boswellia serrata) possess compliance and quality of life can
potent analgesic activity. Thus, the observed contribute to the better prognosis of the
significant improvement in QoL, is due to results in chronic OA patients.
reduction of pain. [16] Symptoms such as pain, stiffness,
Assessment of pain intensity is one tenderness in joints, fatigue or tiredness due
of the primary outcomes used to determine to join pain are some of the symptoms set
the progression of OA. It is highly clinically that defines the quality of life of subjects.
relevant and relatively easy to measure. Pain and stiffness in the morning, after
VAS is a reliable, valid, responsive, and sitting, or after prolonged rest are most
frequently used pain outcome measure. The common. First aim of the treatment to OA
visual analog scale (VAS) is a pain rating should focus on the symptom alleviation so
scale the visual analog scale (VAS) is a patients can experience ease while
validated, subjective measure for acute and mobilizing. [21,22]
chronic pain. [17] In the present study HFPM-01
HFPM-01 treatment represented a treatment group experienced shift of
decrease in VAS score from baseline to end subjects experiencing symptoms such as
of the study. The analgesic activity to morning stiffness, tiredness, muscle cramps,
HFPM-01 could be the contribution of tenderness to mild to no symptoms. This
Withania somnifera, Boswellia serrata, result can indicate that HFPM-01 possess
Zingiber officinale, and Curcuma longa due the potential to provide relief from the
to anti-inflammatory and chondro-protective symptoms related to OA.
International Journal of Research and Review (ijrrjournal.com) 8
Vol.8; Issue: 4; April 2021Veena Deo et.al. A randomized, placebo controlled clinical trial to evaluate the efficacy and safety of HFPM-01
in improving pain, stiffness, and inflammation in patients suffering from knee osteoarthritis
It was evident from the study that the onset healthy cartilage adapts morphology and
of relief from pain and stiffness was within mechanical features so as to respond to
7 days from consumption of HFPM-01 as loading and weight bearing as well. [26] In
per patient diary. the present study, treatment of HFPM-01
Inflammation in OA is chronic and has improved weight bearing capacity of
low-grade inflammation, involving mainly patients with OA that can in turn improve
innate immune mechanisms. In OA, the physical activities and thus quality of life.
synovial fluid has been found to contain There were no adverse events related
multiple inflammatory mediators including to study products.
plasma proteins like C-reactive protein,
prostaglandins (PGE2), leukotriene’s CONCLUSION
(LKB4), cytokines, nitric oxide etc. This It can be concluded from data that
expression can induce matrix there is anti-inflammatory, analgesic
metalloproteinase and other hydrolytic activity exhibited by HFPM-01 treatment in
enzymes (including cyclooxygenase two patients with OA. There was quicker
and prostaglandin E) resulting in cartilage symptom relief and was sustained for period
breakdown secondary to collagen of time. There was improved quality of life
[23]
destruction. of subjects with gastro protective activity
Swelling can be a result of offered by HFPM-01. The treatment with
osteophyte formation, or due to an effusion HFPM-01 proved to be safe and effective
caused by synovial fluid accumulation. for long term use in subjects with OA.
Swelling contribute to disabilities in OA, HFPM-01 can be used as a Monotherapy in
mainly related to pain, difficulty in walking, mild pain and stiffness in osteoarthritic
climbing stairs, performing household conditions while can be used as an adjuvant
chores, and sitting upright and have a when there is necessity to use analgesics as
negative psychological impact, all of which rescue.
can lead to a decreased quality of life. [24]
In the present study subjects Acknowledgments: The authors would like
experiencing inflammation and swelling to acknowledge all the personnel that
were gradually decreased in HFPM-01 contributed to the activities of the research
treatment group which indicates that
HFPM-01 not only reduce pain perception Funding Statement: The financial support
but may be acting to reduce inflammation to conduct this study was given by Siddhayu
and swelling resulting in more sustained Ayurvedic Research Fdn. Pvt. Ltd
action. Further the gastro protective activity
demonstrated by HFPM-01 can allow its Conflicts of Interest: The authors declare
usage for long period of time. that there are no conflicts of interest
In patients with OA, the reduction in regarding the publication of this paper.
muscle strength is attributed to myofibril
atrophy, reduction of muscle quality and Authors' Contributions: All the authors
defective muscle regeneration along with have contributed equally to the research
the bony deformity at synovial joint work.
contribute to the joint rigidity. [25]
In the present study HFPM-01 Ethical Approval: Approved
treatment has improved the joint flexibility
which can further improve range of motion REFERENCES
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