CTRI/2022/10/046353招募中未知
A randomized double-blind placebo controlled clinical study for the comparative evaluation of efficacy and tolerability of commercial extract of Boswellia serrata in improving knee joint health in adult subjects with non/mild osteoarthritis
Daehan chemtech co.,Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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. Ambulatory, male and female subjects 40 to 75 years of age.
- •2. KL (Kellgren Lawrence) grade of 0 to 2.
- •3. At least 30 on 100mm visual analogue scale.
- •4. Subjects having mild-to-moderate pain in knee joint upon completion of 30 sec Chair Stand Test or 80 meter Fast-Paced Walk Test, and otherwise no knee pain at rest.
- •5. Subjects willing to refrain from taking Ibuprofen, Aspirin or other NSAIDS or any other pain reliever (OTC or prescription) during the entire trial.
- •6. Subjects willing to sign the informed consent and comply with study procedure
排除标准
- •1. Subjects with any possible signs / indication / history of arthritis, joint disorders including dislocations and quadriceps tendons tear.
- •2. Subjects with history of underlying inflammatory arthropathy or severe RA or OA.
- •3. Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders.
- •4. Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.
- •5. Subjects with BMI less than 18.5 or more than 30.
- •6. Subjects who consumed the medicines or supplements related with joint health within 30 days before screening visit.
- •7. Subjects who are not acceptable for the test by the judgment of PI.
- •8. Subjects with the history of tobacco smoking.
- •9. Subjects expecting the surgery during the study duration period.
- •10. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •11. Subjects having known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or sensitivity to herbal products.
- •12. Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
- •13. Subjects with history of gout.
- •14. Subjects who have taken corticosteroid, indomethacin, glucosamine+ chondroitin, within 90 days prior to the screening visit or intra-articular treatment / injections with corticosteroid or hyaluronic acid within 90 days preceding the screening visit.
- •15. Subjects with the history of congestive heart failure or any vascular conditions.
- •16. Subjects with the evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurologic diseases, or malignancies, hypothyroidism.
- •17. History of Systemic Lupus Erythematous (SLE).
- •18. High alcohol intake ( >2 standard drinks per day).
- •19. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •20. Participation in any other trials involving investigational or marketed products within 90 days prior to the screening visit.
- •21. Subjects who have consumed Acetaminophen / Paracetamol, Ibuprofen, Aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 30 days prior to the screening visit.
研究者
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