| CTRI Number |
CTRI/2025/12/098792 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study Assessing the Efficacy of Sarcoboost Supplementation in Enhancing Physical Performance, Respiratory Muscle Strength, and Health-Related Quality of Life in Patients With COPD-Related Sarcopenia |
|
Scientific Title of Study
|
A Randomized, Multicentric, parallel-group, Controlled Study to Evaluate the Effect of Sarcoboost Supplementation on Physical Performance, Respiratory Muscle Strength, and Quality of Life in Patients with Sarcopenia and COPD. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-25-004 Version 1.0 dated 06 Aug 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dimple Shah |
| Designation |
Head- Medical Affairs |
| Affiliation |
Zyfis Lifesciences Private Limited |
| Address |
Zyfis Lifesciences Pvt. Ltd.,
511, Silver Radiance 2, Nr. Shakti Arcade, Science City Rd, Sola, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
09979724293 |
| Fax |
|
| Email |
dimple.shah@zyfis.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dimple Shah |
| Designation |
Head- Medical Affairs |
| Affiliation |
Zyfis Lifesciences Private Limited |
| Address |
Zyfis Lifesciences Pvt. Ltd.,
511, Silver Radiance 2, Nr. Shakti Arcade, Science City Rd, Sola, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
09979724293 |
| Fax |
|
| Email |
dimple.shah@zyfis.in |
|
Details of Contact Person
Public Query
|
| Name |
Kalpana Sharma |
| Designation |
Project Manager |
| Affiliation |
Zyfis Lifesciences Private Limited |
| Address |
Zyfis Lifesciences Pvt. Ltd.,
511, Silver Radiance 2, Nr. Shakti Arcade, Science City Rd, Sola, Ahmedabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
09979724293 |
| Fax |
|
| Email |
kalpana.sharma@zyfis.in |
|
|
Source of Monetary or Material Support
|
| Meghmani Lifesciences Limited, 501, 502, Siddhivinayak Tower-B, B/h. DCP Office, S.G. Highway, Makarba, Ahmedabad, Gujarat - 380051, India |
|
|
Primary Sponsor
|
| Name |
Meghmani Lifesciences Limited, |
| Address |
501, 502, Siddhivinayak Tower-B, B/h. DCP Office, S.G. Highway, Makarba, Ahmedabad, Gujarat - 380051, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vaishal Dineshbhai Sheth |
Lungs Care Clinic |
Room No. 608, 6th Floor, Department of Respiratory Medicine, Lungs Care Clinic, Merlin Pentagon Complex, Mahalaxmi, Mahalaxmi Five Rd, Near Jain Merchant, Paldi, Ahmedabad, Gujarat 380007
Ahmadabad
GUJARAT |
9925965133
drvsheth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KKMH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5g Sarcoboost (3g CaHMB + 300mg Magnesium + 600 IU Vitamin D) + Resistance Training + Balanced Diet |
Administered once daily for twelve weeks,
with the option to extend usage for an additional 3 months if continuing in the follow-up phase.
|
| Comparator Agent |
Placebo + Resistance Training + Balanced Diet |
3 times a week |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects aged between 45 and 70 years (both ages inclusive)
2. Diagnosed COPD (GOLD Stage II-III)
3. Diagnosed Sarcopenia (AWGS criteria and Indian consensus)
4. Subjects who are willing to comply with all protocol-specified requirements, including study visits, procedures, and follow-up assessments.
5. Include patients in Gold stage 1. |
|
| ExclusionCriteria |
| Details |
1. Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug
2. Acute exacerbation in past 4 weeks
3. Patients with any other co-morbid conditions barring physical activities which limit or preclude their ability to undergo study assessment
4. Active malignancy
5. Severe heart failure (NYHA Class IV)
6. Known allergy to study supplements
7. Participation in another trial within 3 months
8. Patients with Chronic Renal Failure
9. Patients with severe cases of Sarcopenia
10. Patients on Testosterone therapy/ any other pharmacological therapy for Sarcopenia
11. Patients with Hypothyroidism |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of Sarcoboost on physical performance (SPPB test), O2 saturation and 6 Minute Walk Test (6MWT) in patients with Sarcopenia and COPD. |
Baseline, Post treatment week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Changes in SPPB, O2 saturation and 6MWT
- Change in respiratory muscle strength (MIP/MEP, where feasible) and pulmonary function (as measured by spirometer)
- Changes in Handgrip strength
- Changes in quality of life (SGRQ)
- Changes in calf circumference over the study duration.
- Incidence of adverse events
|
Baseline, Post treatment week 12 and Week 24 ( if extended) |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 multicentric, randomized, parallel-group clinical study evaluates the efficacy and safety of Sarcoboost supplementation in 500 patients with Sarcopenia and COPD. Participants receive either Sarcoboost plus resistance training and a balanced diet or placebo with the same supportive regimen. The study assesses improvements in physical performance (SPPB, 6MWT), oxygen saturation, respiratory muscle strength (MIP/MEP), pulmonary function, handgrip strength, calf circumference, and quality of life (SGRQ) over 12 weeks, with an optional 24-week extension. Safety, tolerability, and adverse events are closely monitored through scheduled visits, patient diaries, and clinical assessments to determine overall treatment benefit. |