| CTRI Number |
CTRI/2024/11/077249 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Cosmix No Nonsense Plant Protein on Muscles gain and weight loss |
|
Scientific Title of Study
|
A double blind Randomized clinical study to study the effect of Cosmix No Nonsense Plant Protein on Muscles gain and weight loss on subjects with Muscle Training |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT 391 Version 1.0 dated 30 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gaurav Gupta |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
2nd Floor room 2, Sports Rehab Area, CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9810799698 |
| Fax |
|
| Email |
dr.gpmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India, 250002 |
|
|
Primary Sponsor
|
| Name |
Cosmix Wellness Pvt Ltd |
| Address |
215/2, S3 Harohalli industrial area, Kanak pura Road, Ramnagar-502112 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Gupta |
CCFT laboratories |
2sd Floor room 2, Rehab Area, CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
Meerut
UTTAR PRADESH |
9810799698
dr.gpmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Test Product: Cosmix No Nonsense Plant Protein with Enzymes |
Test Product: Cosmix No Nonsense Plant Protein, Dose: 1 scope per day 30 minutes post Exercise, Rout of Administration: Oral, Duration: 28 Days |
| Comparator Agent |
Test Product: Cosmix No Nonsense Plant Protein without Enzymes |
Test Product: Cosmix No Nonsense Plant Protein, Dose: 1 scope per day 30 minutes post Exercise, Rout of Administration: Oral, Duration: 28 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Male or Female 18 to 50
2) Subjects willing to give written informed consent
3) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
4) Are free of any systemic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
5) Are willing to join the training program throughout the study duration. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
2. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
3. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
4. Have participated in any interventional clinical trial in the previous 90 days.
5. Have a known sensitivity to any of the constituents of the test product including sensitivities to any ingredient
6. Have used, are using, or are planning to use
immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Muscle Thickness |
Day 0, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Body Fat |
Day 0, Day 28 |
| Change in the weight |
Day 0, Day 28 |
| Change in the Resting Metabolism |
Day 0, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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)
|
A single arm registered clinical study Assessments Muscle Measurement- Hamstring, Biceps, Chest with circumference measure Bioelectrical impedance analysis BIA for Body fat, and resting metabolism Subject’s Assessment Questionnaire for digestion, AE’s, Taste, Ease of Use, etc, as % users experienced X parameter. Assessment timepoints: 4 weeks
|