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临床试验/CTRI/2015/04/005719
CTRI/2015/04/005719招募中2 期

Open labelled, active controlled, randomized evaluation of the effect of Vidangadi Ghanavati in Prameha vis a vis Diabetes Mellitus (Type II).

PDEAs College of ayurved and research centre nigdi pune1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月26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
Assesment of symptoms and effest on BSL Fasting and Post prandial, Urine sugar and glycosylated haemoglobin HbA1c

研究概览

简要总结

The syndrome Diabetes Mellitus has largely been covered under the broad heading of Prameha. It is one of the most common metabolic disorder encountered in clinical practice. A number of factors are known to be important for development of Diabetes mellitus, including obesity, excessive caloric diet, and sedentary life style. Two main types of diabetes are Type I and Type II. Now it is no more a disease related to classes but it is also affecting masses.

Vidangadi Ghana Vati is a classical formulation mentioned in Bhaishajya Ratnavali that consists of Vidang, Shala, Arjun, Katphala, Kadamba, Lodhra , Asana and Kutaj. Vidanga is of Kashay, Katu rasa and ushna having Ushnaveerya. Shalvruksha has kashayras, rukshaguna and is known pramehaghna. Arjun possesses kashay rasa and is laghuruksha. Katphal is of kashay, tikta, katu rasa and ushna virya having laghuruksha guna. Kadamb which is of madhur, kashayras and Lodhra is kashay and laghu ruksha. Asana which is of Kashay, tikta rasa and laghu ruksha guna and known pamehaghna, and Kutaj which is of Tikta – Kashaya rasa, Laghu ruksha guna causes kaphaghna and kledaghna effects by shoshan karma. Hence this combination possesses properties of a potent medicine useful in Santarpan janya Prameha. To make it suitable and palatable in proposed study ghanavati of Vidangadi Kwatha will be used. Hence this study is designed to evaluate the effect of Vidangadi Ghanavati in Prameha vis a vis Diabetes Mellitus (type II).

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Open Label

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Either a known diabetic on treatment or a newly diagnosed diabetic.
  • 2.Patients presenting classical symptoms of Prameha.
  • 3.Patient with fasting blood sugar up to 250 mg% and post prandial blood sugar up to 500 mg%.
  • 4.Patient showing good, fair and moderate control in HbA1c test.

排除标准

  • 1.Patients with fasting blood sugar above 250 mg% and post prandial blood sugar above 500mg%.
  • 2.Insulin Dependent Diabetes Mellitus (IDDM) and those who are under insulin therapy.
  • 3.Pregnant and lactating mothers.
  • 4.Patients with acute complications like Hyperglycemic coma, Ketoacidosis, and infections like gangrene.
  • 5.Patients with chronic complications like Nephropathy, Neuropathy and Retinopathy.

结局指标

主要结局

Assesment of symptoms and effest on BSL Fasting and Post prandial, Urine sugar and glycosylated haemoglobin HbA1c

时间窗: 90 days (3 months)

次要结局

  • Assessment of Lipid profile, Body weight and body mass index.(90 days (3 months))

研究者

发起方
PDEAs College of ayurved and research centre nigdi pune
申办方类型
Private medical college

研究点 (1)

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