Clinical Study on Collagen Peptide of Titan Biotech Limited for OsteoArthritis in Adults.
- Conditions
- Osteoarthritis of knee, unspecified,
- Registration Number
- CTRI/2019/06/019856
- Lead Sponsor
- Titan Biotech Limited
- Brief Summary
**Study Design:** Double Blind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study **Indication:** OsteoArthritis **Investigational Product T****est 1:** Collagen Peptide (Fish Source) **Investigational Product** **Test 2:** Collagen Peptide (Bovine Source) **Comparator:** Placebo **Study Population:** 72 Subjects ; Adults between 30 and 65 years of age with confirmed diagnosis or known history of OsteoArthritis (both ages and all sexes inclusive). **Treatment Duration:** 3 months (90 days)
**RESULTS OF THE CLINICAL STUDY**
**WOMAC SCALE** **Bovine Collagen :** 100% of Subjects have achieved a reduction of >=15 scores in WOMAC score in 90 Days. (Z = 4.80, p = 0.000 < 0.05). End Point Achieved **Fish Collagen :** 100% of Subjects have achieved a reduction of >=15 scores in WOMAC score in 90 Days. (Z = 4.90, p = 0.000 < 0.05) End Point Achieved **Placebo :** 0% of Subjects have achieved a reduction of >=15 scores in WOMAC score in 90 Days. (Z = –5.00, p = 1.00 > 0.05) End Point NOT Achieved **Fish Collagen vs Placebo :** 100% of Subjects in Fish Collagen have achieved a reduction of >=15 scores, while none of subjects have achieved such reduction in “Placebo group†in WOMAC score in 90 days. **Bovine Collagen vs Placebo :** 100% of Subjects in Bovine Collagen have achieved a reduction of >=15 scores, while none of subjects have achieved such reduction in “Placebo group†in WOMAC score in 90 days. **Bovine Collagen vs Fish Collagen :** 100% of Subjects in both treatment arms have achieved a reduction of >=15 scores in WOMAC score in 90 Days. However, the final average reduction WOMAC Score at the end of 90 days is as follows.Bovine Collagen : 19.52 Scores reduced.Fish Collagen : 18.08 Scores reduced. Thus, clinically Bovine Collagen is better than Fish Collagen in reducing WOMAC Scores
**Visual Analog Scale:** **Bovine Collagen:** 100% of Subjects have achieved a reduction of >=3 scores in Pain Scale in 90 Days. (Z = 4.80, p = 0.000 < 0.05). End Point Achieved. **Fish Collagen:** 100% of Subjects have achieved a reduction of >=3 scores in Pain Scale in 90 Days. (Z = 4.90, p = 0.000 < 0.05). End Point Achieved. **Placebo:** 0% of Subjects have achieved a reduction of >=3 scores in Pain Scale in 90 Days. (Z = –5.00, p = 1.00 > 0.05) End Point NOT Achieved. **Fish Collagen vs Placebo :** 100% of Subjects in Fish collagen have achieved a reduction of >=3 scores, while none of subjects have achieved such reduction in “Placebo groupâ€in Pain Scale in 90 Days. **Bovine Collagen vs Placebo :** 100% of Subjects in Bovine collagen have achieved a reduction of >=3 scores, whereas while none of subjects have achieved such reduction in “Placebo group†in Pain Scale in 90 Days. **Bovine Collagen vs Fish Collagen:** 100% of subjects in both treatment arms have achieved a reduction of >=3 scores in Pain Scale in 90 days. (Z = 4.80, p = 0.000 < 0.05) End Point Achieved.However, the final average reduction Pain Score at the end of 90 days is as follows.Bovine Collagen : 5.55 Scores reduced. Fish Collagen : 5.22 Scores reduced. Thus clinically, Bovine Collagen is better than Fish Collagen in reducing Pain associated with Osteoarthritis
**Quality Of Life Questionnaire:** **Bovine Collagen:** 100% of Subjects have achieved a improvement of >=10 Scores in Quality of Life Questionnaire in 90 Days. (Z = 4.80, p = 0.000 < 0.05). End Point Achieved. **Fish Collagen:** 100% of Subjects have achieved a improvement of >=10 Scores in Quality of Life Questionnaire in 90 Days. (Z = 4.90, p = 0.000 < 0.05). End Point Achieved. **Placebo:** 0% of Subjects have achieved a improvement of >=10 Scores in Quality of Life Questionnaire in 90 Days. (Z = –5.00, p = 1.00 > 0.05) End Point NOT Achieved **Fish Collagen vs Placebo :** 100% of Subjects in Fish Collagen have achieved a reduction of >=10 scores, while none of subjects have achieved such reduction in “Placebo group†in Quality of Life Questionnaire in 90 Days. **Bovine Collagen vs Placebo :** 100% of Subjects in Bovine Collagen have achieved a reduction of >=10 scores, while none of subjects have achieved such reduction in “Placebo group†in Quality of Life Questionnaire score in 90 Days. **Bovine Collagen vs. Fish Collagen:** 100% of Subjects in both treatment arms have achieved a improvement of >=10 Scores in Quality of Life Questionnaire in 90 Days. (Z = 4.80, p =0.000 < 0.05). End Point Achieved. However, the final improvement in Quality of Life Questionnaire at the end of 90 days is as follows. Bovine Collagen : 15.18 Scores improved. Fish Collagen : 13.29 Scores improved. Thus clinically, Bovine Collagen is better than Fish Collagen in improving Quality of Life in adults with Osteoarthritis.
**Clinical Global Impression – Improvement scale** **Bovine Collagen**: 100% of Subjects have achieved a score of <=3 Scores in Clinical Global Impression of Change in 90 Days. (Z = 4.80, p = 0.000 < 0.05). End Point Achieved **Fish Collagen:** 100% of Subjects have achieved a score of <=3 Scores in Clinical Global Impression of Change in 90 Days. (Z = 4.90, p = 0.000 < 0.05). End Point Achieved **Placebo:** 0% of Subjects have achieved a score of <=3 Scores in Clinical Global Impression of Change in 90 Days. (Z = –5.00, p = 1.00 > 0.05) End Point NOT Achieved. **Fish Collagen vs Placebo :** 100% of Subjects in Fish Collagen have achieved a reduction of <=3 scores, while none of subjects have achieved such reduction in “Placebo group†in Clinical Global Impression of Change score in 90 Days. **Bovine Collagen vs Placebo :** 100% of Subjects in Bovine Collagen have achieved a reduction of <=3 scores, while none of subjects have achieved such reduction in “Placebo group†in Clinical Global Impression of Change score in 90 Days. **Bovine Collagen vs Fish Collagen:** 100% of Subjects in both treatment arms have achieved a score of <=3 Scores in Clinical Global Impression of Change. However, the average Clinical Global Impression Scale at the end of 90 days is as follows.Bovine Collagen : 1.87 Scores improved. Fish Collagen : 2.75 Scores improved. Thus both statistically and clinically, Bovine Collagen is better than Fish Collagen as per Clinical Global Impression of Change. In Osteoarthritis in 90 days (t = -6.07, p-value =0.000<0.05).
**Safety Results of the clinical study:** No adverse event was reported in this clinical study. The safety investigations also showed no clinical difference from baseline to end of the study.
**Overall Study Conclusion:** Overall, it is concluded that both Bovine Collagen and Fish Collagen was effective in the management of Pain and Symptoms of Osteoarthritis. However, clinically Bovine Collagen is deemed clinically better than Fish Collagen for the treatment of OsteoArthritis. No adverse event was reported upon consumption of both Bovine Collagen and Fish Collagen. The safety investigations also showed no clinical difference from baseline to end of the study. Based on the results of this Clinical Study Report, Bovine Collagen Peptide and Fish Collagen Peptide of Titan Biotech Limited/Stalwart Nutritions Pvt. Ltd is recommended as a safe and effective therapy in the management of OsteoArthritis in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 78
- 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 Kellergen Lawrence (KL) Grade.
- 3.Subject with pain (VAS score ≥4) on walking in one or both knees 24 hours prior to screening.
- 4.Subjects with BMI ≤35 at the time of screening.
- 5.Subjects who are ambulatory, requiring but not currently receiving or not satisfied with anti-inflammatory or anti-analgesic drugs.
- 6.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
- 7.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
- 1.Subjects with known hypersensitivity to investigational product or its constituents.
- 2.Subjects with known hypersensitivity to NSAID, aspirin, COX-2 inhibitors and other analgesic medicine.
- 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.Significant (requiring surgical correction) valgus or varus deformity of the knee, ligamentous laxity, or meniscal instability.
- 7.Concomitant inflammatory or any other disease/condition which may affect joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis etc.).
- 8.History of sepsis in any joint or any clinical concern for a sub-acute infectious process in the target joint.
- 9.History of surgery in the target joint.
- 10.Planned surgery on any lower extremity joint.
- 11.Clinically significant venous or lymphatic stasis present in the leg(s).
- 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/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.
- 16.Females who are pregnant or lactating or planning to become pregnant during the study period.
- 17.Subjects who 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 4.Clinical Global Impression Scale based on X Ray Impression: Score of ≤3 by end of treatment 1.WOMAC Scale: Day 1, Day 45, Day 90 | 2.Visual Analogue Scale: Day 1, Day 45, Day 90 | 3.Quality of life Questionnaire: Day 1, Day 45, Day 90 | 4.Clinical Global Impression Scale based on X Ray Impression: Day 1, Day 45, Day 90 1.WOMAC Scale: Reduction by ≥15 scores by end of treatment period. 1.WOMAC Scale: Day 1, Day 45, Day 90 | 2.Visual Analogue Scale: Day 1, Day 45, Day 90 | 3.Quality of life Questionnaire: Day 1, Day 45, Day 90 | 4.Clinical Global Impression Scale based on X Ray Impression: Day 1, Day 45, Day 90 2.Visual Analogue Scale: Reduction by ≥3 scores by end of treatment period. 1.WOMAC Scale: Day 1, Day 45, Day 90 | 2.Visual Analogue Scale: Day 1, Day 45, Day 90 | 3.Quality of life Questionnaire: Day 1, Day 45, Day 90 | 4.Clinical Global Impression Scale based on X Ray Impression: Day 1, Day 45, Day 90 3.Quality of life Questionnaire: Improvement by ≥10 scores by end of treatment period. 1.WOMAC Scale: Day 1, Day 45, Day 90 | 2.Visual Analogue Scale: Day 1, Day 45, Day 90 | 3.Quality of life Questionnaire: Day 1, Day 45, Day 90 | 4.Clinical Global Impression Scale based on X Ray Impression: Day 1, Day 45, Day 90
- Secondary Outcome Measures
Name Time Method Not applicable Not applicable
Trial Locations
- Locations (1)
Raam Clinic
🇮🇳Chennai, TAMIL NADU, India
Raam Clinic🇮🇳Chennai, TAMIL NADU, IndiaDr VT SriraamPrincipal investigator9840909155md@auroushealthcare.com