Clinical Study on Collagen Capsules (Chicken) for Adults with Pain in Joints due to wear and tear (osteoarthritis)
- Conditions
- Health Condition 1: M169- Osteoarthritis of hip, unspecifiedHealth Condition 2: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2023/09/058043
- Lead Sponsor
- Titan Biotech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method