CTRI/2025/09/094793招募中2 期
An open label single arm clinical evaluation of Arogyavardhini Vati with Kumaryasava in the management of Yakriddalyudara (non alcoholic fatty liver disease)
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月25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
- 60
- 试验地点
- 1
- 主要终点
- Improvement in USG grading of fatty liver after 60 days Changes in LFT parameters (SGOT, SGPT, ALP, GGT etc.)
研究概览
简要总结
This study is a single arm clinical evaluation of Arogyavardhini vati and Kumaryasava in Yakriddalyudara ( non alcoholic-fatty liver disease). This will be conducted on 60 random selected patients from OPD13,14 of Kayachikitsa department of Patanjali Ayurveda Hospital, Haridwar.
First follow-up during treatment - 30th day and second follow-up at the end of treatment i.e. 60th day.
Assessment will be done on the basis of subjective and objective parameters as discussed earlier.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Grade I and II fatty liver Elevated SGOT, SGPT, ALP Newly diagnosed or treated NAFLD cases Controlled diabetes with fatty liver Willingness to participate and consent.
排除标准
- •Hepatitis B,C, autoimmune, drug-induced hepatitis, alcoholic liver disease Serious systemic illnesses Grade III fatty liver Pregnancy/lactation.
结局指标
主要结局
Improvement in USG grading of fatty liver after 60 days Changes in LFT parameters (SGOT, SGPT, ALP, GGT etc.)
时间窗: First follow-up 4 weeks | Second follow-up 8 weeks
次要结局
- Reduction in symptoms such as weakness, anorexia, indigestion, abdominal pain,constipation, vomiting, mild fever, fatigue, excessive thirst(Baseline, 30thday, 60th day)
研究者
MONIKA GIRI
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR
研究点 (1)
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