| CTRI Number |
CTRI/2023/07/054764 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Fish Collagen from Athos Collagen Pvt. Ltd to treat Joint Pain |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Randomised, Non-Comparative Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “FiColla†from Athos Collagen Private Limited as a Nutritional Supplement in Adult Subjects with Joint Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/ORT/081/23 Version 01 26-Apr-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sriraam VT |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room No 1,
Department of General Medicine,
Research Division
No. 128,Shakthy Flats,NTR Garden Street, Flats 01 and 02 ,Ground Floor Rangarajapuram main road, Kodambakkam,
Chennai
TAMIL NADU
600034
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sriraam VT |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room No 1,
Department of General Medicine,
Research Division
No. 128,Shakthy Flats,NTR Garden Street, Flats 01 and 02 ,Ground Floor Rangarajapuram main road, Kodambakkam,
Chennai
TAMIL NADU
600034
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sriraam VT |
| Designation |
Investigator |
| Affiliation |
Aurous HealthCare R&D India Pvt. Ltd. |
| Address |
Room No 1,
Department of General Medicine,
Research Division
No. 128,Shakthy Flats,NTR Garden Street, Flats 01 and 02 ,Ground Floor Rangarajapuram main road, Kodambakkam,
Chennai
TAMIL NADU
600034
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Athos Collagen Private Limited
319,Blue Eminence, Opp.Sangini Gardenia, Jahangirpura-Dandi Road ,Surat,395005,Gujarat. |
|
|
Primary Sponsor
|
| Name |
Athos Collagen Private Limited |
| Address |
319,Blue Eminence, Opp.Sangini Gardenia, Jahangirpura-Dandi Road, Surat,395005,Gujarat. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
128,Shakthy Flats,N TR Garden Street,
Flats 01 and 02 ,Ground Floor
Rangarajapuram main road, Kodambakkam,
Chennai, 600024.Tamil Nadu.
|
|
|
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,
Research Division
No. 128,Shakthy Flats,NTR Garden Street,
Flats 01 and 02 ,Ground Floor
Rangarajapuram main road, Kodambakkam,
Chennai, 600024.Tamil Nadu.
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: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FiColla of Athos Collagen Pvt. Ltd. |
Dose : 4 gm in one sachet
Dosage : One sachet to be emptied into 100ml luke warm water, mixed well and consumed immediately.
Treatment Duration : 90 days
Route of Administration : Oral
|
| Comparator Agent |
Not Applicable. Single Arm Non Comparative Study. |
Not Applicable. Single Arm Non Comparative Study. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects between ages of 35 and 66 years both ages and all genders inclusive with active joint pain not attributed to a specific diseases or disorder
2. Subjects who have a pain score of 5 to 7 on a 10 point NRS at time of screening in a minimum of one joint.
3. Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements that are indicated at improving joint pain, joint and muscle health.
4. Subjects who are willing to give informed consent for participation , able to comprehend and understand the responsibilities during screening and treatment period.
5. Subjects who are willing not to participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to the ingredients of the investigational product. Subjects who are on collagen supplements in any form.
2. Subjects who are vegetarians or vegans who object to consumption of animal origin investigational product.
3. Subjects who have active infections diseases or disorder that will prevent them from satisfying the responsibilities of the study.
4. Subjects with a history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
5. Subjects remission from cancer of any type less than 5 years at the time of screening 6. Subjects who are planning a pregnancy and or currently breastfeeding.
subjects who have participated in a clinical study less than 1 month before screening.
7. Any significant medical condition such as 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.
8. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
9. Subjects who in the opinion of the investigator are not eligible for enrollment in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
WOMAC :Reduction of Total Score greater than equal to 10 from baseline
Pain NRS Scale : Reduction of Total Score greater than equal to 2 from base line
Global Rating of change Scale :Reduction of Total Score greater than equal to 2 from base line based on improvement in Xray
IP Feedback Questionnaire: Total score greater than or equal to 15 by the end of the study
|
WOMAC: Day 1,Day 45,day 90
Pain NRS Scale: Day 1,Day 45,Day 90
Global Rating of Change scale: Day 90
IP Feedback Questionnaire: Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "29"
Final Enrollment numbers achieved (India)="29" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/07/2023 |
| Date of Study Completion (India) |
10/11/2023 |
| 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
Modification(s)
|
Study Design : Open Label, Prospective ,Non Randomized ,Non Comparative Single Arm Clinical Study Indication : Pain in Unspecified Joint Investigational Product : FiColla Comparator: Not Applicable .Single Arm Non Comparative Study Dose/Dosage
Dose: 4gm in One sachet.
Dosage: One sachet to be emptied into 100 ml luke warm water, mixed well and consumed immedaitely for 90 days Subject Population : Adult subjects between the ages of 35 and 65 years both ages and all genders inclusive with unspecified joint pain not attributed to a specific diseases or disorder Number of Subjects : 30 Evaluable Subjects Treatment Arms: I Treatment Duration: 90 days Efficacy Assessments
1. Pain NRS : Day 1, Day 45, Day 9
2. WOMAC: Day 1, Day 45,Day 90
3. Global Rating of Change Scale: Day 90
4. IP feedback Questionnaire: Day 90 Safety Assessments
1. Clinical Safety: CBC, Serum Biochemistry
2. Monitoring of Adverse Events Background of the study: Pain is the most common and compelling reason for seeking medical care. Patients seek medical care for evaluation and symptom relief of pain because it interferes with activities of daily living,causes emotinal distress and resuts in lack of confidence in ones health. Purpose of the Study : FiColla is a marine collagen supplement, fish collagen peptide exerts a possitive effect on collagen synthisis, collagen quality and matrix mineralization in an osteoblastic cell culture system, likely by upregulating the gene expression of the respective collagen modifying enzymes. This suggests the potential utility of FCP as a biomaterial for bone healing and regeneration. FiColla is a 100 percent fish collagen peptide from Athos Collagen Pvt.Ltd. that is aimed at effectively treatment for joint pain in adults |