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临床试验/CTRI/2019/01/017351
CTRI/2019/01/017351已完成1/2 期

Randomized controlled trial of Kushtadi Churna Vati as an add-on effect in the management of Madhumeha

The Principal MAMs Sumatibhai Shah Ayurved College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月2日最近更新:

试验速览

阶段
1/2 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha.

研究概览

简要总结

Randomized controlled trial of Kushtadi Churna Vati as an add-on effect in the management of Madhumeha. Diabetes mellitus is a long term metabolic disorder that is characterized by high blood sugar, insulin resistance and relative lack of insulin. We have developed newer medicines ,but we come across limitations of OHA, therefore there is a need for traditional need for the better management of DM. Considering all above things the study will be carried out in comparison with conventional modern treatment. Patients will be divided in two groups containing 30 each. All the drugs having Pramehaghna properties as well as having Kaphahara, vatahara, Medohara and kledashoshak properties. Thus they can be helpful in reducing the symptoms and Samprapti Vighatan of the disease.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • A known Diabetic on treatmenet and a newly diagnosed Diabetes.
  • Patient with fasting blood sugar upto 220mg% and post prandial blood sugar upto 300mg% 3.patient having HBA1C upto 10 4.Patient having fasting blood sugar in between 221 to 250 and post prandial 301 ton 350 will be included , if HBA1C is upto
  • If the patient is taking ayurvedic medicine for Madhumeha , washing period for them will be 8 days.

排除标准

  • Patients with fasting blood sugar above 220 mg% and post prandial blood sugar above 300mg%.
  • Patient who is already taking Ayurvedic management for Madhumeha.
  • Diabetes Mellitus Type-I ,Acromegaly, Cushing’s syndrome and pancreatic disorder.
  • Those who are under Insulin therapy.
  • Pregnant and lactating mothers.
  • Patients with acute complications like Hyperglycemic coma, Ketoacidosis and infections like gangrene.
  • Patients with K/C/O Nephropathy, Neuropathy and Retinopathy.
  • Patients with gastrointestinal diseases, Liver diseases, tumors, conditions like cardiovascular disease, acute myocardial infarction, immune-compromised disease(HIV).

结局指标

主要结局

To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha.

时间窗: 3 months

次要结局

  • 1)To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha on the basis of subjective parameters.(2)To evaluate the efficacy of Kushtadi Churna vati in reducing the elevated Blood Sugar Levels in Madhumeha in fasting state.)

研究者

发起方
The Principal MAMs Sumatibhai Shah Ayurved College
申办方类型
Private medical college

研究点 (1)

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