| CTRI Number |
CTRI/2024/02/062298 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate the efficacy of Gremin in Healthy Humans. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Study to Evaluate the Effect of Gremin® on Endurance, Muscle Performance and Muscle Protection in Healthy Human Subjects. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-ZH-123 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan M E |
| Designation |
Professor of General Medicine |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drmohanbgsresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ZeusHygia LifeSciences Private Ltd,
First Floor, Plot No.47, Raviraja Industries,
Technocrats Industrial Estate, Balanagar,
Hyderabad, Telangana-500037
India |
|
|
Primary Sponsor
|
| Name |
ZeusHygia LifeSciences Private Ltd |
| Address |
First Floor, Plot No.47, Raviraja Industries, Technocrats Industrial Estate, Balanagar, Hyderabad, Telangana-500037 India |
| Type of Sponsor |
Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohan M E |
BGS Global Institute of Medical Sciences |
Department of General medicine,
5th Floor, Research Ward,
No.67,BGS Health and Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA |
9482164779
drmohanbgsresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Hematological and Biochemical Parameters. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gremin 500mg |
Oral Administration of single 500 mg Gremin capsule once a day for 14 days |
| Comparator Agent |
Placebo 500mg |
Oral Administration of single 500 mg Placebo capsule Once a day for 14 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderate physically active (regular aerobic exercise for at least 2-3 hours per week)
2. Body Mass Index (BMI) ≤ 30 kg per m2
3. Subjects with no known musculoskeletal pathology
4. Subjects who are non-smokers
5. Female subjects of childbearing age, agree to use approved birth control methods during the
study and have a negative urine pregnancy test (UPT) at screening
6. Subjects willing to adhere to their routine diet, physical activity, and general lifestyle
throughout the study
7. Must be willing and able to give informed consent and comply with the study procedures
|
|
| ExclusionCriteria |
| Details |
1. Subjects currently on or taken in the prior month any anti-inflammatory or analgesic or antioxidant drugs
2. Subjects having symptoms of viral infection
3. Subjects with history of abnormal liver or renal function tests, laboratory findings suggestive of an active inflammatory or infectious
process and presence of any known disease in last 3 months.
4. Subjects with history of
- Uncontrolled or serious medical illness including diabetes, liver disease, hypertension
- Cardiac Disease or Neurological Problems
- Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes)
- Gastrointestinal tract bleeding or peptic ulcer disease
- Psychiatric disorders or current alcoholism or drug abuse
- Drug abuse, smoking, abuse or addiction to alcohol
- Eating disorder such as bulimia or binge eating
- Endocrine abnormalities including stable thyroid disease
- Any major surgery, including cardiovascular surgery and surgery of oesophagus, stomach or duodenum, bariatric surgery
5. Subjects with open wounds
6. Subjects with injury involving skeletal system or deep soft tissue injury in last 3 months
7. Subjects on steroids or ergogenic users since past 3 months
8. Subjects who maybe allergic to any of the natural constituents of the Investigational Product
9. Pregnant and lactating women
10. Known HIV or Hepatitis B positive or any other immuno-compromised state
11. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
12. Any additional conditions that in the Investigators opinion that may interfere with subject
treatment, assessment or compliance with the protocol and would warrant exclusion from the
study or prevent the subject from completing the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in endurance, Isometric muscle strength and fatigue |
Baseline, Day 7, Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in Biomarkers |
Baseline, Day 7, Day 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a randomized (1:1), double-blind, placebo-controlled, parallel-group clinical study. Healthy moderately active subjects meeting all inclusion and no exclusion criteria will be screened in the study. After passing the eligibility criteria, subjects will be randomized to receive Gremin®, 500 mg or placebo once a day after meals for a period of 14 days. Eligible subjects will undergo baseline assessments: endurance assessment by physical performance tests, isometric muscle strength test, and fatigue assessments. All assessments will be repeated at follow-up visit (Day 7) and end of study visit (Day 14). Blood samples will be collected for biomarker analysis and safety assessments. |