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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

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. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098792
Enrollment
500
Registered
2025-12-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: M628- Other specified disorders of muscle

Interventions

Intervention1: 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 add

Sponsors

Meghmani Lifesciences Limited,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Baseline, Post treatment week 12

Secondary

MeasureTime frame
- 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 Timepoint: Baseline, Post treatment week 12 and Week 24 ( if extended)

Countries

India

Contacts

Public ContactKalpana Sharma

Zyfis Lifesciences Private Limited

dimple.shah@zyfis.in09979724293

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026