Clinical Study on Three Doses of Bioactive Collagen Peptide vs Conventional Collagen Peptide vs Placebo in Knee Joint Osteoarthritis.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2021/04/032912
- Lead Sponsor
- itta Gelatin India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 106
1. Adults between 30 and 65 years of age with confirmed diagnosis or known history of Osteoarthritis, with moderately active lifestyle-both ages and all sexes inclusive-.
2. Subject with Grade II or III of Kellgren Lawrence-KL Grade.
3. Subject with pain on walking in one or both knees for the past 6 months. Pain Scale score greater than or equal to 4 at the time of screening.
4. Subjects who are ambulatory, requiring but not currently receiving or not satisfied with anti-inflammatory or anti-analgesic drugs.
5. Subject or LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
6. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
1. Subjects with known hypersensitivity or vegetarians or vegans who object to consumption of animal origin investigational product.
2. Subjects with contraindications to MRI- pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implant, suspicion of metallic foreign body, claustrophobia.
3. Subjects with known hypersensitivity to NSAID, aspirin, COX-2 inhibitors and other analgesic medicine.
4. Subjects who have had hyaluronic acid injections, upto 6 months prior to enrolment.
5. Subjects who have had Intra-Articular Steroid, upto 3 months prior to enrolment.
6. Subjects with immunocompromised state complications.
7. Significant-requiring surgical correction-valgus or varus deformity of the knee, ligamentous laxity or meniscal instability.
8. Concomitant inflammatory or any other disease or condition which may affect joints-e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudo gout, chondrocalcinosis etc.
9. History of surgery in any joint or any clinical concern for a sub-acute infectious process in the target joint.
10. History of surgery in the target joint or planned surgery or any lower extremity joint.
11. Clinically significant venous or lymphatic stasis present in the leg-s-.
12. Clinically apparent tense effusion or inflammation at the target knee.
13. Any musculoskeletal condition that would impede measurement of efficacy at the target joint.
14. Subjects with uncontrolled diabetes, hypertension or congestive heart failure.
15. Any significant medical condition-e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor-e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation.
16. Females who are pregnant or lactating or planning to become pregnant during the study period.
17. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
18. Subjects who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. WOMAC: Reduction by greater than or equal to 20 scores <br/ ><br>2. Pain Scale: Reduction by greater than or equal to 4 scores. <br/ ><br>3. Quality of life Questionnaire: improvement by greater than or equal to 10 scores 4. Objective Assessment Based on XRay: Physician s Impression of Change Scale: Score of 2 or 1. <br/ ><br>5. Serum cTx: Reduction of 10% <br/ ><br>6. SOS Medication: Frequency, Dose and Dosage of SOS Medication. <br/ ><br>7. MRI Analysis: MOAKS: Improvement of greater than or equal to 10% for cohort <br/ ><br>Timepoint: 1. WOMAC Scale: Day 1, Day 30, Day 60 and Day 90 <br/ ><br>2. Pain Scale-VAS: Day 1, Day 30, Day 60 and Day 90 <br/ ><br>3. Quality of life Questionnaire: Day 1, Day 30, Day 60 and Day 90 <br/ ><br>4. Objective Assessment Based on XRay: Day 90 <br/ ><br>5. Serum CTX: Day 1 and Day 90 <br/ ><br>6. MRI Analysis: MOAKS: Day 1 and Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable