CTRI/2022/07/043661尚未招募2 期
A Randomised Controlled Clinical Study to Evaluate Efficacy of Saptachakra Churna (Salacia Reticulata) in Madhumeha w.s.r Type-2 DM
Dr Javeed Chougala1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月7日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of the treatment will be done based on detailed case proforma with objective parameters FBS and PPBS
研究概览
简要总结
This study is a randomised, single blind, parallel group, actively controlled clinical study with comparative standard drug - Amalaki Churna and Trial drug - Saptachakra Churna with the dosage 5gm churna with ushnodaka before food BID. This study is conducting in Madhumeha patients belongs to age group between 20yrs - 70yrs who gives written and verbal consent for undergoing clinical study. Study will be conducting in Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri. Intervention of the study is 30 days with day zero, day 11, day 21 and day 31 assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with FBS range Between
- •250 mg/dL and PPBS range between
- •350 mg/dL Type-2 Diabetes Mellitus will be selected for the study.
排除标准
- •Patients with High blood glucose levels FBS > 250mg/dL and PPBS > 350 mg/dL
- •Patients with complications like DKA, HHS, Diabetic Gangrene and Carbuncles
- •Gestational Diabetes, Patients on Insulin Type 2 Diabetes Mellitus.
- •Diabetes with other Endocrine Disorders are excluded from the study
- •Patients suffering from other Systemic Diseases which may interfere with study will be excluded.
结局指标
主要结局
Effect of the treatment will be done based on detailed case proforma with objective parameters FBS and PPBS
时间窗: 30 days
次要结局
- Effect of the treatment will be done based on detailed case proforma with subjective parameters such Prabhuta avila mutra, Ati Kshudha, Ati Trusha, Ati Sveda(30 days)
研究者
研究点 (1)
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