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

Completed

Conditions: Osteoarthritis of knee, unspecified,

Registration Number: CTRI/2021/10/037187

Lead Sponsor: OmniActive Health Technologies

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 Sponsorâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 135

Inclusion Criteria

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 â‰¤ 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.

Exclusion Criteria

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 â‰¥140 mm Hg and Diastolic Blood Pressure â‰¥ 90 mm Hg).
11.Subject with a history of uncontrolled diabetes.
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.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in WOMAC Index	Visit 7 (Day 84)

Secondary Outcome Measures

Name	Time	Method
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 - 1Î²	Visit 4 (Day 5), Visit 7 (Day 84)
Mean change in endurance from baseline as assessed by distance covered over a time of 6 minutesâ€™ 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)

Trial Locations

Locations (4): Chopda Medicare & Research Centre
🇮🇳
Nashik, MAHARASHTRA, India
K. R. Hospital attached to Mysore Medical College and Research Institute
🇮🇳
Mysore, KARNATAKA, India
Royal Hospital
🇮🇳
Pune, MAHARASHTRA, India
Sahyadri AsthirogBalrog Dental Nursing Home and Maternity Center
🇮🇳
Aurangabad, MAHARASHTRA, India
Chopda Medicare & Research Centre
🇮🇳Nashik, MAHARASHTRA, India
Dr Aniket Shah
Principal investigator
9822910309
draniket@gmail.com