| CTRI Number |
CTRI/2022/07/043919 [Registered on: 12/07/2022] 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
|
Study on "Isocure" - A nutritional powdered supplement to treat joint pain in adults.
|
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Isocure†of Essen Fooddies India Pvt. Ltd. as a Nutritional Supplement in Adult Subjects with Joint Pain. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/NUT/063/20 Version 01 03May22 |
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 |
#180/109, G1&G2, RR Villa,
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 |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
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 |
#180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Essen Fooddies India Pvt. Ltd. |
|
|
Primary Sponsor
|
| Name |
Essen Fooddies India Pvt Ltd |
| Address |
KINFRA Park, Kakkancherry
Malappuram 673635,
Kerala, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
#180/109, G1&G2, RR Villa,
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 |
Department of General/Family Medicine
Room no 7. #180/109, G1&G2, RR Villa,
Rangarajapuram Main Road, Kodambakkam,
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 |
Isocure |
Route of Administration : Oral
Formulation : Liquid
Dose : 1 sachet (35.71g) in 150ml cold water
Dosage : OD for 3 months
|
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects between the ages of 21 and 65 years (both ages and all genders inclusive) with active joint pain.
2. 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.
3. Subjects who have a pain score of 2-5 on a 10 point VAS at the time of screening in a minimum of one joint.
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 participate in any other clinical trial during participation in the current trial.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to the ingredients of the investigational product
2. Subjects who are on collagen supplements in any form.
3. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product.
4. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
5. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
6. Subjects on remission from cancer of any type less than 5 years at the time of screening
7. Subjects who are planning a pregnancy and/or currently breastfeeding.
8. Subjects who have participated in a clinical study less than 1 month before screening.
9. 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.
10. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
11. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. WOMAC Scale : Reduction of 20% from baseline
2. Pain Scale: Reduction of 20% from baseline
3. IP Feedback Questionnaire : Total Score of 20
|
1. WOMAC Scale : Day 1, Day 45, Day 90
2. Pain Scale: Day 1, Day 45 Day 90
3. IP Feedback Questionnaire : Day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/07/2022 |
| Date of Study Completion (India) |
08/01/2023 |
| 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
|
None. Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Design : Open Label, Prospective, Non-Randomised,
Non-Comparative, Single Arm Clinical Study
Indication : Nutritional Supplement for Adults with Joint Pain
Investigational Product Details
Name : Isocure
Route of Administration : Oral
Formulation : Powdered Nutritional Formulation
Dose : 1 sachet (35.71g) in 150ml cold
water
Dosage : OD for 3 months
Subject Population : Adult subjects between the ages of 21 and 65 years
(both ages and all genders inclusive) with active joint pain.
Treatment Arms : One. Non Comparative Single Arm
Study
Number of Subjects : 50 Subjects
Efficacy Assessments:
1. WOMAC Scale : Day 1, Day 45, Day 90
2. Pain Scale: Day 1, Day 45 Day 90
3. IP Feedback Questionnaire : Day 90
Safety Assessments:
1. Clinical Safety : CBC, Serum Biochemistry
2. Monitoring of Adverse Events
Background of the study: Joint
pain is a discomfort that arises from any joints. Joint pain may be due to
advanced age, participation in activities that put pressure in the joint and
obesity. The larger prevalence of joint
pain among people has impacted their daily activities and the ability to do
work. Current pharamacolgical treatment
such as mild pain
relievers, like acetaminophen, and nonsteroidal anti-inflammatory drugs, such
as ibuprofen, can provide partial or complete relief of moderate joint and
muscle pain despite their adverse effects on
long-term usage. An alternative treatment with nutritional supplements with
higher levels of safety and effectiveness are needed. 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 join pain. In addition, collagen peptide also has been shown to exert a
beneficial effect on skin, hair, nail and muscle health.
Purpose of the Study : Isocure by Essen Fooddies comes with the advantage of
having collagen peptide as its key component that helps in maintaining healthy
joints and muscles. |