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CTRI Number  CTRI/2020/07/026603 [Registered on: 15/07/2020] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the effect of dietary supplement capsules compared to Placebo capsules on joint health 
Scientific Title of Study   A prospective, interventional, randomized, double-blind, multiple dose, parallel, placebocontrolled study to assess the efficacy of dietary supplement capsules of OmniActive Health Technologies, India, on joint health and muscle strength of subjects. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
G7SYN/P-008/2019 VERSION : 01 DATE : 13-01-2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Alexander  
Designation  Head Clinical Research  
Affiliation  G7 Synergon Private Limited  
Address  No 537 9th Cross 5th main Tata Nagar
Sahakaranagar Post Bangalore Karnataka India Bangalore
Bangalore
KARNATAKA
560092
India 
Phone  09916252529   
Fax    
Email  ajay.alexander@g7synergon.in  
 
Details of Contact Person
Scientific Query  
Name  Dr D Sathish Kumar  
Designation  Managing Director 
Affiliation  G7 Synergon Private Limited  
Address  No 537 9th Cross 5th main Tata Nagar
Sahakaranagar Post Bangalore Karnataka India Bangalore
Bangalore
KARNATAKA
560092
India 
Phone  09677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Details of Contact Person
Public Query  
Name  Dr D Sathish Kumar  
Designation  Managing Director 
Affiliation  G7 Synergon Private Limited  
Address  No 537 9th Cross 5th main Tata Nagar
Sahakaranagar Post Bangalore Karnataka India Bangalore

KARNATAKA
560092
India 
Phone  09677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Source of Monetary or Material Support  
OmniActive Health Technologies,Phoenix House T8 A Wing 462 Senapati Bapat Marg Lower Parel Mumbai 400013  
 
Primary Sponsor  
Name  OmniActive Health Technologies  
Address  Phoenix House T8 A Wing 462 Senapati Bapat Marg Lower Parel Mumbai 400013  
Type of Sponsor  Other [Pharmaceutical industry-Indian ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Dhadiwal  Dhadiwal Hospital in Coalition with Shreeji Health Care  Clinical Research Department,Opp. New CBS, Trimbak Road, Nashik – 422002, Maharashtra, India
Nashik
MAHARASHTRA 		 9823040106

dhadiwalhospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHREEJI INSTITUTIONAL ETHICS COMMITTEE (SIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M17||Osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dietary supplement capsules   Dose: One capsule Route of administration:Oral Frequency: One capsule in morning Instruction: consume one capsule every morning after the breakfast at the same time every day for 84 days  
Comparator Agent  Placebo  Dose: One capsule Route of administration:Oral Frequency: One capsule in morning Instruction: consume one capsule every morning after the breakfast at the same time every day for 84 days  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male and/or female subjects aged between 35 and 75 years
(both limits inclusive).
2. Clinical diagnosis of unilateral or bilateral knee osteoarthritis
for at least greater than 3 months, as presented by pain in the
knee at least for last 3 months.
3. Subject with index knee joint pain rated ≥ 60 on a 100-point
Pain-VAS scale.
4. Subject with knee osteoarthritis grade II/III (Kellgren-
Lawrence classification).
5. Subjects willing to be involved in regular physical activity
such as walking, climbing stairs, recording forms, eating,
exercise behaviors, etc.
6. Subjects who are able to walk for at least 6 minutes at a
moderate-to-brisk pace on treadmill.
7. Subjects willing to avoid NSAIDs and other antiinflammatory
medications during the study period.
8. Subjects who agree to stay weight stable during the study
period.
9. Subject able to follow the instruction for Investigational
product administration and is 100% compliant with
Investigational product during placebo run-in period.
10. Female subjects of child bearing potential practicing an
acceptable method of birth control such as Intrauterine Device
in place for at least 3 months prior to the start of the study and
remaining in place during the study period, contraceptive
transdermal, injection or implants, non-hormonal or
hormonal, abstinence: Subjects who shall be practicing
abstinence shall agree to have a documented second
acceptable method of birth control should the subject become
sexually active during the course of her study participation for
the duration of the study as judged by the investigator(s)/study
physician and agree to follow the same should be used during
treatment.
OR
Postmenopausal for at least 1 year.
OR
Surgically sterile (bilateral tubal ligation/bilateral
oophorectomy/hysterectomy has been performed on the
subject).
11. Subjects willing to provide written consent.
12. Subjects shall be willing and able to understand and comply
with the requirements of the study, consume the study IP as
instructed, return for the required treatment period visits,
comply with therapy prohibitions, and be able to complete the
study. 
 
ExclusionCriteria 
Details  1. Subjects who are pregnant, nursing, or planning a pregnancy
within the study participation period.
2. Subjects with positive Urine Pregnancy Test at Screening
/Randomization Visit.
3. Subjects with previous history of knee osteoarthritis for more
than 3 years.
4. Subjects with previous history of any knee joint replacement
surgery.
5. Subjects with severe knee osteoarthritis in Grade 4 as per
Kellgren and Lawrence Scale.
6. Subjects unwilling to refrain from the use of NSAIDs
(including low dose aspirin 50 mg/day for cardiovascular
health) or herbal/ nutraceutical supplements for joint health or
local analgesics during the study duration.
7. Subjects with history hypothyroidism and have the thyroid
deficiency except euthyroid.
8. History of allergy or sensitivity to Curcumin, Boswellia and
Ashwagandha, related compounds or any component of the
formulation.
9. Subjects with use of any immunosuppressive drugs in the last
12 months (including steroids).
10. Subjects with poorly controlled hypertension. (Systolic Blood
Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm
Hg).
11. Subjects with history of uncontrolled diabetes.
12. Subjects with history of restless leg syndrome.
13. Subjects with evidence of malignancy.
14. Use of Glucocorticoid injection or hyaluronic acid injection in
the affected joint within 3 months prior to enrolment.
15. Subjects with a chronic pain syndrome and in the judgment of
the Investigator is unlikely to respond to any therapy.
16. Subjects with history of significant trauma or surgery in the
lower limb.
17. History or presence of active rheumatic disease that may be
responsible for secondary knee osteoarthritis.
18. Subjects with history of diabetic neuropathy.
19. Subjects with history of deep vein thrombosis.
20. Subjects with history of major chronic hepatic,
cardiovascular, neurological or immunosuppressive
conditions or the presence of any infections.
21. Subjects with history of bilateral hip joint replacements.
22. Subjects with current use of the following medications:
monoamine oxidase inhibitors, prescription or herbal weight
loss medications/dietary supplement.
23. Any condition that, in the opinion of the investigator, renders
the subject unable to participate in the study.
24. Subjects who smoke or consume tobacco products.
25. Subjects who have been treated with any investigational drug
or investigational device within a period of 3 months prior to
study entry.
26. Subjects who are taking calcium and vitamin D beyond RDA
levels. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
WOMAC Index  Day 84 (week 12) 
 
Secondary Outcome  
Outcome  TimePoints 
WOMAC Index  Day 5  
joint pain  Day 5 
joint health-Lequesne Index  Day 5 
joint pain - VAS  Day 84 (week 12) 
endurance  Day 84 (week 12) 
muscle strength  Day 84 (week 12) 
joint health by Lequesne Index  Day 84 (week 12) 
inflammation  Day 84 (week 12) 
serum
COMP, Serum CTX-II and serum MMP-3 		 Day 84 (week 12) 
Quality of Life (QoL)  Day 84 (week 12) 
rescue medication  Day 84 (week 12) 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Suspended 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
To assess the effect of dietary supplement capsules compared to
Placebo capsules on joint health
 
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