Evaluation of the safety & efficacy of Zandu Chyawanprash debility & symptoms associated with weak immunity
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Kasa - Cough symptom score
研究概览
简要总结
Zandu Chyawanprash is a Classical Ayurvedic medicine and traditional poly-herbal Rasayana formulation marketed in India from decades for the management of general debility and symptoms associated with weak immunity. To further validate these findings, we intend to evaluate the efficacy and safety of this product using clinical parameters. The study’s objective is to validate the clinical efficacy of Zandu Chyawanprash on the basis of scientific parameters and to evaluate the safety of Zandu Chyawanprash. The study will be conducted at Main Campus, Faculty of Ayurveda, Uttarakhand Ayurved Hospital, Harrawala.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject having any three symptoms among Kasa (Cough), Svarabheda (Hoarseness of voice), Agnimandya (Digestive impairment), Smritidaurbalya (Cognitive issues), Daurbaly (Weak strength, stamina & low energy), Kshin Anamaya (Weak immunity – Frequent illness such as common cold, body ache), Apraharsh (decreased vigour) Age- 18 years- 65 Years of either sex Co-operative and fully conscious.
排除标准
- •Diabetes mellitus, Severe bronchial Asthma /COPD, Any symptomatic cardiac disease, Chronic debilitating conditions like hepatic/ renal insufficiency Carcinogenic condition (Confirmed through history/clinical examination), Any acute illness/ serious illness, Fever/ delirium, hypertension, Known hypersensitivity or allergy to one or more of the herbal ingredients, Recent (less than 1 month) participation in a clinical trial, Recent (less than 1 month) use of any Herbal/Ayurvedic drugs, Other debilitating neurological or psychiatric disorders, Any condition likely to hinder the compliance with the protocol.
结局指标
主要结局
Kasa - Cough symptom score
时间窗: Day 0, Day 30, Day 60, Day 75
Agnimandya - Severity of the symptoms of indigestion on the basis of Likert scale
时间窗: Day 0, Day 30, Day 60, Day 75
Smritidaurbalya – Verbal recall
时间窗: Day 0, Day 30, Day 60, Day 75
Daurbalyata - Visual Analouge Scale score
时间窗: Day 0, Day 30, Day 60, Day 75
Kshin Anamay (Weak immunity) – History of frequent illness
时间窗: Day 0, Day 30, Day 60, Day 75
Stress & Anxiety – Hamilton anxiety rating scale
时间窗: Day 0, Day 30, Day 60, Day 75
次要结局
- Hemoglobin, TLC, DLC, ESR, SGPT, SGOT, Urea, Creatinine, FBS(Day 0, Day 30, Day 60)
研究者
Prof Radha Ballabh Sati
Uttarakhand Ayurved University, Faculty of Ayurveda, Main Campus, OPD no. 11