Immuno-modulatory effect of Ritu Haritaki along with Gud In healthy individual during the Greeshma Ritu – A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes from baseline measurements in IgG antibody investigation
研究概览
简要总结
The study is randomized control trial to compare the effect of Haritaki with Gud in Greeshma Ritu as a immunomodulator and other group with placebo. In one group Haritaki(3gm) with Gud(6gm) will be given daily early morning empty stomach and follow up on 0th , 20th , 40th , 61st day will be done. In another group , placebo (Roasted wheat flour) in 3gm dose is given and follow up done on 0th , 20th , 40th , 61st day . The trial will be conducted in Ch. brahm prakash ayurved charak sansthan with outcome i.e taking Ritu Haritaki in Greeshma Ritu has an immunomodulatory effect and Changes from baseline measurements in IgG antibody investigation will be seen .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy volunteers of either sex in age group 18-30 year 2.Participants willing to give a written consent.
排除标准
- •Patients with concurrent Hepatic Dysfunction or Renal Dysfunction ,uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Neurological disorders, endocrine disorders, etc.) or known cases of malignancy.
- •Contraindications of haritaki mention in charak Samhita and bhavprakash
- •Women who are planning for conception / pregnant or lactating.
- •Patients suffering from Psychosis/depressive illness
- •History of hypersensitivity to any of the trial drugs or their ingredients.
- •Patient taking participation in any other clinical trial.
结局指标
主要结局
Changes from baseline measurements in IgG antibody investigation
时间窗: 0th , 61st day
次要结局
- Changes in WHO quality of life scale
研究者
Dr Rohit Mandal
Chaudhary Brahm Prakash Ayurved Charak Sansthan