CTRI/2025/08/092507招募中2 期
Evaluating the efficacy of Chandraprava Vati on purvarupa of Madhumeha(Prediabetes): An open label randomized clinical trial
Dr Sanjib Kumar Das1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2025年8月18日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- HbA1c should be less than 5.7%
研究概览
简要总结
Various studies conducted on prediabetic individuals for prevention of progression to diabetes which include pharmacology therapy, yoga, life style modification. However ADR of pharmacolgy therapy and hurdles in long term sustainability of other interventions are found to be hurdles. Hence there is need of safe and effective remedies for its prevention which Ayurveda can do.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Fulfill prediabetes diagnostic criteria HbA1c = 5.7-6.4% Capable and willing of giving signed consent form BMI (25-30) kg/m2.
排除标准
- •Patients with H/o prior use of medication to treat diabetes or diagnosed with diabetes Newly diagnosed patients Currently using oral hypoglycemic agents Decompensated cardiac, kidney, hepatic failure, endocrine disorder.
- •Patients having used any medication for DM or pre diabetes in last 1 month.
- •Pregnant and lactating females.
- •Who have participated in any other study within 1 month before this study conditions where there is an altered relationship between A1C and glycemia, such as; some hemoglobin variants, pregnancy (second and third trimesters and the postpartum period), glucose-6-phosphate dehydrogenase deficiency, HIV, hemodialysis, recent blood loss or transfusion, or erythropoietin therapy.
结局指标
主要结局
HbA1c should be less than 5.7%
时间窗: 6 month of study
次要结局
- Assessment of improvement in LFT, KFT, Lipid profile, CBC, HOMA-IR, HOMA-Beta,
研究者
Dr Sanjib Kumar Das
Affiliated to NCISM, Govt of India
研究点 (1)
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