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CTRI Number  CTRI/2021/10/037187 [Registered on: 08/10/2021] Trial Registered Prospectively
Last Modified On: 10/12/2024
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, parallel, placebo-controlled study to assess the efficacy of two doses of Curcuwin Ultra plus on joint health and muscle strength in subjects with mild knee osteoarthritis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
G7SYN/P-003/2021, VERSION NO-01,Dated 30-08-2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Alexander  
Designation  Medical Monitor  
Affiliation  G7 Synergon Private Limited  
Address  No 537 9th Cross 5th main Tata Nagar Sahakaranagar Post Bangalore Karnataka India

Bangalore
KARNATAKA
560092
India 
Phone  9916252529  
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
KARNATAKA
560092
India 
Phone  9677014651   
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  9677014651   
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  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aniket Shah  Chopda Medicare & Research Centre  Consulting room OPD, Ground floor, Plot No.3, Patil Colony, Canada Corner, Nashik, Maharashtra-422005.
Nashik
MAHARASHTRA 		 9822910309

draniket@gmail.com 
Dr Mohd Ejazul Haq Chand  K. R. Hospital attached to Mysore Medical College and Research Institute  OPD block, Ground floor, Room NO 3 K. R. Hospital attached to Mysore Medical College and Research Institute, Irwin Road, Mysuru-570001, Karnataka.
Mysore
KARNATAKA 		 9986629058

dr.ejazulhaq@gmail.com 
Dr Nilesh Jagtap  Royal Hospital  OPD 1st room, 1st floor, Anupam Arcade, Pune-Satara Road, Katraj, Pune- 411 046, Maharashtra.
Pune
MAHARASHTRA 		 9890757391

nileshrjagtap@gmail.com 
Dr Sachin Bedmutha  Sahyadri AsthirogBalrog Dental Nursing Home and Maternity Center  Sahyadri Asthirog, Balrog, Dental, Nursing Home and Maternity Center, Aurangabad
Aurangabad
MAHARASHTRA 		 7447890766

sachinbedmutha1981@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee Ajanta Superspeciality Hospital (EC-ASH)  Approved 
IEC-Sai Sneh Hospital and Daignostic Centre  Approved 
Institutional Ethics Committee, Mysore   Submittted/Under Review 
Magna-care Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcuwin Ultra plus powder in a capsule. Strength: Curcuwin Ultra plus 250 mg (Total Curcuminoids 50 mg)   Subjects shall be instructed to consume one capsule every morning after breakfast, at the same time every day, for 84 days (12 weeks). 
Intervention  Curcuwin Ultra plus powder in a capsule. Strength: Curcuwin Ultra plus 500 mg (Total Curcuminoids 100 mg)   Subjects shall be instructed to consume one capsule every morning after breakfast, at the same time every day, for 84 days (12 weeks). 
Comparator Agent  Microcrystalline cellulose in a capsule. Manufactured by: OmniActive Health Technologies, India.   Subjects shall be instructed to consume one capsule every morning after breakfast, at the same time every day, for 84 days (12 weeks). 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male and/or female subject aged between 35 and 75 years (both limits inclusive).
2. Subject with 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 ≤ 44 on a 100-point Pain-VAS scale.
4. Subject with knee osteoarthritis grade II (Kellgren- Lawrence classification).
5. Subject willing to be involved in regular physical activity such as walking, climbing stairs, recording forms, eating, exercise behaviors, etc.
6. Subject who is able to walk for at least 6 minutes at a moderate-to-brisk pace on the treadmill.
7. Subject willing to avoid NSAIDs and other anti-inflammatory medications during the study period.
8. Subject who agrees to stay weight stable during the study period.
9. Subject who is able to follow the instruction for investigational product administration and is 100% compliant with an investigational product during the Run-In Period.
10. Female subject 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 planning 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 as judged by the investigator(s)/study physician and agree to follow the same 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. Subject is willing to provide written consent.
12. Subject is 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. Subject who is pregnant, nursing, or planning a pregnancy within the study participation period.
2. Subject with positive Urine Pregnancy Test at Screening Visit.
3. Subject with a previous history of knee osteoarthritis for more than 3 years.
4. Subject with a previous history of any knee joint replacement surgery.
5. Subject with moderate to severe knee osteoarthritis in Grade III or IV as per Kellgren and Lawrence Scale.
6. Subject 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. Subject with history of hypothyroidism and have thyroid deficiency except euthyroid.
8. History of allergy or sensitivity to Curcumin, and related compounds or any component of the formulation.
9. Subject with use of any immunosuppressive drugs in the last 3 months (including steroids).
10. Subject with poorly controlled hypertension (Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg).
11. Subject with a history of uncontrolled diabetes.
12. Subject with a history of restless leg syndrome.
13. Subject with evidence of malignancy.
14. Use of glucocorticoid injection or Hyaluronic Acid injection in the affected joint within 3 months prior to enrolment.
15. Subject with a chronic pain syndrome and in the judgment of the investigator is unlikely to respond to any therapy.
16. Subject with a 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. Subject with a history of diabetic neuropathy.
19. Subject with history of deep vein thrombosis.
20. Subject with history of major chronic hepatic, cardiovascular, neurological, or immunosuppressive conditions or the presence of any infections.
21. Subject with history of bilateral hip joint replacements.
22. Subject with current use of 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. Subject who smoke or consume tobacco products.
25. Subject who has been treated with any investigational product or investigational device within a period of 3 months prior to study entry.
26. Subject 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 and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change from baseline in WOMAC Index  Visit 7 (Day 84) 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change from baseline in WOMAC Index   Visit 4 (Day 5) 
Mean change in joint pain from baseline as determined by VAS-pain score   Visit 4 (Day 5), Visit 7 (Day 84) 
Mean change in the inflammation from baseline as determined by serum hsCRP and serum IL - 1β   Visit 4 (Day 5), Visit 7 (Day 84) 
Mean change in endurance from baseline as assessed by distance covered over a time of 6 minutes’ walk on the treadmill   Visit 7 (Day 84) 
Mean change in muscle strength from baseline as assessed by knee flexor and extensor strength readings on Hand-Held Dynamometer (HHD)   Visit 7 (Day 84) 
Mean change in Range of Motion (ROM) from baseline in degrees measured by goniometer  Visit 7 (Day 84) 
Mean change in cartilage health from baseline as determined by serum COMP, Serum CTX-II, and serum MMP-3  Visit 7 (Day 84) 
Mean change from baseline in the rescue medication usage (Paracetamol)   Visit 7 (Day 84) 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="135" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2021 
Date of Study Completion (India) 05/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  publishing the data

  6. For how long will this data be available start date provided 31-05-2022 and end date provided 30-07-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

OmniActive Health Technologies, India (Sponsor) is developing a nutritional supplement - Curcuwin Ultra+. This randomized, double-blind, parallel, placebo-controlled, clinical interventional study has been designed to establish efficacy and safety of Curcuwin Ultra+, manufactured by OmniActive Health Technologies, India (Sponsor), in the treatment of adult subjects with mild knee OA.

Placebo group is included to confirm the sensitivity of the study and minimize the possibility of a false positive result of the study.

Allocation ratio of 1:1:1 for Sponsor’s Curcuwin Ultra+ 250 mg capsules (Test Product 1) or Curcuwin Ultra+ 500 mg capsules (Test Product 2) or Placebo capsules during the treatment period is considered in this study.

 
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