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临床试验/CTRI/2024/07/070520
CTRI/2024/07/070520尚未招募3 期

An open label randomized comparative clinical study to evaluate the efficacy of Bahumutrantaka Rasa and Chandrakala Vati in Madhumeha vis-a-vis Type 2 Diabetes Mellitus

Dr Sharanya R1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月1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
40
试验地点
1
主要终点
To compare the efficacy of Bahumutrantaka Rasa and Chandrakala Vati in Madhumeha vis-à-vis Type 2 Diabetes Mellitus.

研究概览

简要总结

Prameha is characterized by *‘Prabhuta’*and â€˜Avila’ MootrataMadhumeha is a type of Vataja Prameha, characterized by the passage of excessive urine having quality similar to Madhu. It is one among the Astamahagada.

Type 2 Diabetes Mellitus is a heterogeneous condition characterized by varying degrees of Insulin resistance and β-cell dysfunction. It is one of the lifestyle disorders whose prevalence is rising more rapidly in almost all countries.

In the present scenario, Santarpanajanya Vikaras are given much importance as it is a very common set of disorders. A sedentary lifestyle such as lack of exercise, sleeping during the daytime, consumption of excessive sweets and oily food, change in dietary habits precipitate the Santarpanajanya Vikaras such as Prameha.

India is topped in the world with the highest number of people with Diabetes Mellitus. India has around 101 million people living with Diabetes and another 136 million people in Pre-Diabetes stages.About 422 million people worldwide have Diabetes. Diabetes Mellitus is fast-growing public health challenge of the 21st century as the prevalence rate will be >30% in the next 35 years. India is gaining the status of a potential epidemic with >62 million Diabetic individuals and is expected to double this number by the year 2040.

Management of T2DM encompasses lifestyle adjustments, medications and in certain instances insulin therapy. Pharmacotherapy includes a range of oral hypoglycemic drugs. Despite the considerable advancements made in the control of T2DM, there are still problems that persist. These challenges encompass the requirement of treatment strategies, for the mitigation of medication-related adverse effects, mitigation of complications associated with the condition, potential for enhancing positive outcomes in T2DM subjects.

Medicines used in the study, Bahumutrantaka Rasa and Chandrakala Vati being herbomineral formulations have Mehahara property, their efficacies are evaluated and compared in the subjects diagnosed with Madhumeha vis-à-vis Type 2 Diabetes Mellitus.

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
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group between 30-70 years irrespective of gender. 2.Non-insulin dependent. 3.FBS level greater than 126 mg/dl. 4.PPBS level greater than 200mg/dl. 5.HbA1C greater than 7%.
  • upto 10%. 6.Subjects taking Allopathic oral Anti-diabetic drugs.

排除标准

  • 1.Subjects with diagnosed cases of severe systemic diseases like Cardiac Disease, Renal Function Impairment and Pulmonary Tuberculosis.
  • 2.Subjects having complications of Diabetes like Ketoacidosis, Nephropathy and Diabetic wounds.
  • 3.Known subject of any active malignancy.
  • 4.Pregnant women and lactating mothers.

结局指标

主要结局

To compare the efficacy of Bahumutrantaka Rasa and Chandrakala Vati in Madhumeha vis-à-vis Type 2 Diabetes Mellitus.

时间窗: Pre test - 0th day | Mid test - 31st day | Mid test -61st day | Post test - 91st day

次要结局

  • To evaluate the efficacy of Bahumutrantaka Rasa in Madhumeha vis-à-vis Type 2 Diabetes Mellitus.(To evaluate the efficacy of Chandrakala Vati in Madhumeha vis-à-vis Type 2 Diabetes Mellitus.)

研究者

发起方
Dr Sharanya R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sharanya R

Rajiv Gandhi University of Health Sciences

研究点 (1)

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