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.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects aged between 45 and 70 years (both ages inclusive)
- •Diagnosed COPD (GOLD Stage II-III)
- •Diagnosed Sarcopenia (AWGS criteria and Indian consensus)
- •Subjects who are willing to comply with all protocol-specified requirements, including study visits, procedures, and follow-up assessments.
- •Include patients in Gold stage 1.
排除标准
- •Patients with known history of intolerance, hypersensitivity or any other contraindication to study drug
- •Acute exacerbation in past 4 weeks
- •Patients with any other co-morbid conditions barring physical activities which limit or preclude their ability to undergo study assessment
- •Active malignancy
- •Participation in another trial within 3 months
- •Patients with Chronic Renal Failure
- •Patients with severe cases of Sarcopenia
- •Patients on Testosterone therapy/ any other pharmacological therapy for Sarcopenia
- •Patients with Hypothyroidism.
研究者
Dr Dimple Shah
Zyfis Lifesciences Private Limited