CTRI/2023/09/058043尚未招募3 期
A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Unstergen from Titan Biotech Limited as a Nutritional Supplement in Adult Subjects with Osteoarthritis - NI
Titan Biotech Limited0 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
- 3 期
- 状态
- 尚未招募
- 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. Adult subject between the ages of 30 and 65 years with confirmed diagnosis or known history of OsteoArthitis (both ages and sexes inclusive)
- •2. Subjects who have a pain score 5-7 on a 10point NRS at the time of screening in a minimum of one joint .
- •3. Subjects who are willing to abstain form the use of herbal, allopathic or other nutritional supllements that are indicated at improving osteoarthitis ,Bone health,joint pain.
- •4. Subjects who are ambulatory requiring but not currently receiving or not satsified with anti -inflammatory or anti analgesic drugs.
- •5. Subjects who are willing to give infromed consent for participation ,able to comphrend and understand the responsibilites during screening and treatment period.
- •6. Subject who are willing not to participate in any other clinical trail during participation in the current trail.
排除标准
- •1. Subjects with known hypersensitivity to the ingredients of theinvestigational product.
- •2. Subjects who are on collagen supplements in any form.
- •3. Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment.
- •4. Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment.
- •5. Subjects with immunucompromised state complications.
- •6. History of surgery in the target joint.
- •7. Planned surgery on any lower extremity joint.
- •8. Clinically significant venous or lymphatic stasis present in the leg(s).
- •9. Clinically apparent tense effusion or inflammation at the target knee.
- •10. Any musculoskeletal condition that would impede measurement of efficacy at the target joint.
- •11. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product.
- •12. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
- •13. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •14. Subjects on remission from cancer of any type less than 5 years at the time of screening.
- •15. Subjects who are planning a pregnancy and/or currently breastfeeding.
- •16. Subjects who have participated in a clinical study less than 1 month before screening.
- •17. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g. planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •18. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •19. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
研究者
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