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临床试验/CTRI/2025/09/095212
CTRI/2025/09/095212尚未招募3 期

A clinical study of effect of Marma Chikitsa, Nisha-amalaki and Shilajatu on the cases of newly diagnosed Type 2 Diabetes Mellitus.

Institute of Medical Science Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2025年10月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
225
试验地点
1
主要终点
1.blood sugar profile

研究概览

简要总结

225 cases of Diabetes Mellitus will be included in the interventional study which will be randomly divided into 3 groups of 75 in each group. one group will be controlled group prescibed  Metformin(500mg) OD before meal with water for a period of 3 month. Second group will be prescibed Nisha amalaki churna 6gm BD and Shiljatu capsule 500mg BD respectively with lukewarm water for a period of 3 month.  third group will be prescibed Nisha amalaki churna 6gm BD and Shiljatu capsule 500mg BD respectively with lukewarm water for a period of 3 month, three follow ups of marma chikitsa(kurpara marma) will be done at the interval of one month for over a period of 3 month.

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
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient having clinical feature and diagnostic criteria of diabetes mellitus 2.Pateint having fasting glucose level 126-200mg per dl(greater than 7.0mmolpermol) 3.Pateint having Hba1c 6.5to10 percent(greater than 48mmol/mol) 4.Pateint having post prandial blood glucose level 200 to 300mgperdl.

排除标准

  • 1.Pateint suffering from complications and other chronic diseases 2.Pateint having fasting glucose level less than126more than200mg per dl 3.Pateint having post prandial blood glucose level less than 200 more than 300mgperdl 4.Pateint having Hba1clower than 6.5 greater than10 percent 5.Pateint already on therapy for other cause 6.Pregnant and lactating women.

结局指标

主要结局

1.blood sugar profile

时间窗: 3 months with Follow up at 1 month interval

2.lipid profile

时间窗: 3 months with Follow up at 1 month interval

3.physically examination

时间窗: 3 months with Follow up at 1 month interval

次要结局

  • Grading Scale for diabetic symptoms(months with Follow up at 1 month interval)

研究者

发起方
Institute of Medical Science Banaras Hindu University
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

ARUNA SINGH

Banaras Hindu University

研究点 (1)

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