CTRI/2020/07/026603尚未招募未知
A prospective, interventional, randomized, double-blind, multiple dose, parallel, placebocontrolledstudy to assess the efficacy of dietary supplement capsules of OmniActive HealthTechnologies, India, on joint health and muscle strength of subjects.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
- •Postmenopausal for at least 1 year.
- •Surgically sterile (bilateral tubal ligation/bilateral
- •oophorectomy/hysterectomy has been performed on the
- •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
排除标准
- •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
- •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
- •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
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