| CTRI Number |
CTRI/2019/06/019856 [Registered on: 25/06/2019] Trial Registered Prospectively |
| Last Modified On: |
13/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
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Clinical Study on Collagen Peptide of Titan Biotech Limited for OsteoArthritis in Adults. |
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Scientific Title of Study
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A Double Blind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Collagen Peptide of Titan Biotech Limited in the Treatment of OsteoArthritis in Adult Subjects. |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| AHC/ORT/054/19 Version 01 31-May-19 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Principal Investigator |
| Affiliation |
Aurous HealthCare R & D India Private Limited |
| Address |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Principal Investigator |
| Affiliation |
Aurous HealthCare R & D India Private Limited |
| Address |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Principal Investigator |
| Affiliation |
Aurous HealthCare R & D India Private Limited |
| Address |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
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Source of Monetary or Material Support
|
| Titan Biotech Limited
Unit I: A-902 A, RIICO Industrial Area, Phase III, Bhiwadi - 301019. Rajasthan. India. |
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Primary Sponsor
|
| Name |
Titan Biotech Limited |
| Address |
Unit I: A-902 A, RIICO Industrial Area,
Phase III, Bhiwadi - 301019.
Rajasthan. India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
180/109, G1 and G2, RR Villa, Rangarajapuram Main Road, Chennai- 600024 |
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room No. 1
180/109, G1, RR Villa, Rangarajapuram main road, Kodambakkam
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
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Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Intervention |
Collagen Peptide (Bovine) |
10g of product to be dissolved in warm water and consumed once a day, for 90 days |
| Intervention |
Collagen Peptide (fish) |
10g of product to be dissolved in warm water and consumed once a day, for 90 days |
| Comparator Agent |
Placebo |
10g of product to be dissolved in warm water and consumed once a day, for 90 days |
|
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Inclusion Criteria
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| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
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| ExclusionCriteria |
| Details |
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).
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/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.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
1. WOMAC Scale: Reduction by ≥15 scores by end of treatment period.
2. Visual Analogue Scale: Reduction by ≥3 scores by end of treatment period.
3. Quality of life Questionnaire: Improvement by ≥10 scores by end of treatment period.
4. Clinical Global Impression Scale based on X Ray Impression: Score of ≤3 by end of treatment
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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
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Secondary Outcome
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| Outcome |
TimePoints |
| Not applicable |
Not applicable |
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Target Sample Size
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Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
28/06/2019 |
| Date of Study Completion (India) |
10/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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Nil |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
Study Design: Double Blind, Prospective, Placebo Controlled, Randomised, Three Arm Clinical Study
Indication: OsteoArthritis
Investigational Product Test 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.
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