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临床试验/CTRI/2023/11/059441
CTRI/2023/11/059441尚未招募3 期

A clinical study to evaluate the efficacy of Gomutra haritaki yog in the management of prameha(Madhumeha)W.S.R. Diabete mellitus type 2

Madan Mohan Malviya Govt Ayurved College Udaipur1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月11日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Symptoms like

研究概览

简要总结

This is a parallel group study to evaluate the efficacy of  gomutra haritaki in the management of diabetes mellitus type 2.In this study,group A,50 patients will be administered with gomutra haritaki, 5 gm, od for the duration of 3 months.And group B,50 patients will be advised to follow pathya-apathya of prameha for 3 months

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
25.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •The patients having clinical sign & symptoms of the Prameha (Madhumeh) & willing for trial.
  • •The patients who ages in between 25 – 70 years will be selected 3.international diagnosis criteria for diabetes (WHO) (A) Patient having F.B.S. level >125 mg/dl <250 mg/dl (6.9 mmol/lit.) (B) P.P.B.S. level >180 mg/dl to <350 mg/dl (10 mmol/lit.) will be selected for the trial
  • •Either sex of different socio-economic groups.

排除标准

  • •IDDM patients
  • •Gestational diabetes.
  • •Diabetes Mellitus produced due to other illnesses like Acromegaly, Cushing’s syndrome, pancreatic disorders etc.
  • •Acute complications Diabetic Keto-acidosis & hyperglycemic hyperosmolar coma.
  • •Pregnant & Lactating Mother.
  • •History of severe unstable angina, MI, CVA, Renal failure.

结局指标

主要结局

Symptoms like

时间窗: 3 months

Polyurea, Turbidity, burning sensation in palm and sole, polydipsia, fatigue, general weakness, polyphagia, sugar in the urine, and cramps will be analyzed

时间窗: 3 months

次要结局

  • fasting blood sugar & post prandial blood sugar will be analyzed(1 month & 2 months)

研究者

发起方
Madan Mohan Malviya Govt Ayurved College Udaipur
申办方类型
Government medical college

研究点 (1)

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