Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified Health Condition 2: M628- Other specified disorders of muscle
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
Zyfis Lifesciences Private Limited