CTRI/2021/10/037187
Recruiting
未知
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.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Sponsor
- OmniActive Health Technologies
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 ââ?°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.
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 ââ?°Â¥140 mm Hg and Diastolic Blood Pressure ââ?°Â¥ 90 mm Hg).
Outcomes
Primary Outcomes
Not specified
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