CTRI/2026/02/104434尚未招募2/3 期
An Open-Label Randomized Controlled Clinical Study to Evaluate the Effect of Shivagutika Rasayana versus Sharapunkadi Churna in the Management of Non-Alcoholic Fatty Liver Disease w.s.r. to Kaphaja Yakritodara
SDM College of Ayurveda Hospital and Reseach Centre Udupi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月1日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This study is the Randomized, Open Label, Parallel Group single centred trial comparing the efficacy of Shivagutika rasayana and Sharapunkadi Churna in 100 subjects with Non-Alcoholic Fatty Liver Disease in India. The study includes 63-65 days of intervention (mrudu virechana+medication) and 30 days of follow up period. Total duration of study: 93-95 days. The primary outcome measures will be changes in USG Abdomen for Liver, Biochemical analysis including Liver Function Test and Lipid profile. Secondary outcome measures includes Body Mass Index (BMI), Blood Pressure, Waist Circumference, BRAD Score, Quality of life scale (HRQoL).
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient fitting into the diagnostic criteria.
- •Subjects fit to undergo treatment protocol as per the study protocol and voluntarily give written informed consent.
排除标准
- •Patients with history of alcohol intake.
- •Patients with recent positive history of other liver diseases such as viral hepatitis, autoimmune hepatitis, Wilsons disease, alpha 1 antitrypsin deficiency, hemochromatosis.
- •Patients having fasting blood sugar (FBS) more than 200 mgdl and postprandial blood sugar (PPBS) more than 250 mgdl, despite taking oral hypoglycemic agents, Stage II hypertension, i.e., systolic blood pressure more than 160 mmHg and diastolic blood pressure more than 100 mmHg, despite taking antihypertensive drugs Any other conditions, which in the opinion of the investigator/s, makes the patient unsuitable for enrollment or could interfere with his/her participation and completion of the study.
研究者
Shreyashri N Suvarna
SDM College of Ayurveda Hospital and Research Centre Udupi
研究点 (1)
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