| CTRI Number |
CTRI/2023/09/058043 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study on Collagen Capsules (Chicken) for Adults with Pain in Joints due to wear and tear (osteoarthritis) |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/ORT/084/23 Version 01 27-Apr-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room No 1, Department of General Medicine,
Division of Research and Development
Plot No. 128, Sakthy Flats, NTR Garden Street,
Flats 01&02, Ground Floor, Rangarajapuram Main Road,
Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room No 1, Department of General Medicine,
Division of Research and Development
Plot No. 128, Sakthy Flats, NTR Garden Street,
Flats 01&02, Ground Floor, 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 |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room No 1, Department of General Medicine,
Division of Research and Development
Plot No. 128, Sakthy Flats, NTR Garden Street,
Flats 01&02, Ground Floor, Rangarajapuram Main Road,
Kodambakkam,
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Titan Biotech Limited
Unit II E-539-540, RIICO Industrial Area,
Phase III, Bhiwadi - 301019. Rajasthan. India
|
|
|
Primary Sponsor
|
| Name |
Titan Biotech Limited |
| Address |
Unit II E-539-540, RIICO Industrial Area,
Phase III, Bhiwadi - 301019. Rajasthan. India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
Room No 1, Department of General Medicine,
Division of Research and Development
Plot No. 128, Sakthy Flats, NTR Garden Street,
Flats 01&02, Ground Floor, Rangarajapuram Main Road,
Kodambakkam, Chennai-600024. Tamilnadu, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room No 1, Department of General Medicine,
Division of Research and Development
Plot No. 128, Sakthy Flats, NTR Garden Street,
Flats 01&02, Ground Floor, Rangarajapuram Main Road,
Kodambakkam, Chennai-600024.
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Dose: 40mg placebo
Dosage : One capsule to be consumed once a day
Treatment Duration : 90 days
Route of Administration : Oral
|
| Intervention |
Unstergen Capsules |
Dose : 40mg Chicken Collagen
Dosage : One capsule to be consumed once a day
Treatment Duration : 90 days
Route of Administration : Oral |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. WOMAC: Reduction by greater than equal to 10 total score from baseline
2. Pain NRS Scale : Reduction by greater than equal to 2 scores from baseline
3. Quality of Life Questionnaire : Total score of greater than equal to 15 by end of the study.
4. Global Rating of Change Scales : Score of greater than equal to +2 scores based on improvement in X RAY (Cohort Analysis)
|
1. WOMAC : Day 1, Day 45,Day 90
2. Pain NRS Scale : Day 1, Day 45,Day 90
3. Quality of Life Questionnaire : Day 45, Day 90
4. Global Rating of Change Scales : Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None. Not Applicable. |
None. Not Applicable. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2023 |
| Date of Study Completion (India) |
20/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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 |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design : A Double Blind, Prospective, Randomised,
Comparative, Placebo Controlled Clinical Study. Indication : Osteoarthitis of Knee Unspecified,
Osteoarthitis of Hip Unspecified Investigational Product : Unstergen Capsules (40 mg Chicken Collagen)
Comparator: Placebo
Dose : 40mg Capsule
Dosage : One capsule to be consumed once a day for 90 days Subject Population : Adult subjects between the ages of 30 and 65
years with confirmed diagnosis or known history of OsteoArthritis
(both ages and all sexes inclusive)
Number of Subjects : 45 Evaluable Subjects Treatment Arms
Treatment Arm I :
Unstergen Capsules
Treatment Arm II : Placebo : 16 Subjects
Treatment Duration : 90 days Assessments
1.WOMAC : Day
1, Day 45,Day 90
2. Pain NRS Scale : Day 1, Day 45,Day 90
3. Quality of Life Questionnaire : Day 45, Day 90
4. Global Rating of Change Scales : Day 90 Background of the study: Osteoarthritis (OA) is the
most prevalent chronic joint disease, affecting 30–50% of adults over 65 years.
The burden of disease is growing in relation to aging and the increasing levels
of obesity in the world population. It is a heterogeneous disease for which age
and obesity have been recognized as prominent risk factors; however, additional
critical factors have been identified, including genetics, mechanical stress,
injury and hormonal modifications. All joints may be affected but the most
common localizations are the knee and hip.
Purpose of the Study : Collagen is the most abundant protein found
in animals and is the key structural component in the connective tissues of
cartilage, tendons, and ligaments, as well as in a multitude of organs such as
blood vessels, bones, lung, heart, kidney, liver, teeth, and skin. Collagen
supplements are intended to replenish your body’s natural supply of the
protein. Dietary intake of collagen peptide has been shown to reduce
Osteoarthritis.
This clinical study is done to evaluate the safety and Effectiveness of “
Unstergen Capsules â€from Titan Biotech Limited as a Nutritional Supplement in
Adult Subjects with Osteoarthritis. |