Randomised comparative clinical trial to evaluate the efficacy of Chandrakala gutika and Mamajjaka Ghanavati in the management of madhumeha with special reference to Diabetes Mellitus type II
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be the change in FBS/PPBS levels from baseline to the end of the treatment period.
研究概览
简要总结
Diabetes mellitus (DM) is defined as a disturbance of intermediary metabolism, manifesting as a chronic sustained hyperglycemia primarily due to either an absolute or relative lack of insulin. It is a metabolic disorder characterized by polyuria, polydipsia, weight loss, fatigue etc., sometimes associated with complications of retina, kidney, and nervous system. India has already become the “ Diabetes Capital” of the world, with over 3 crore affected patients, which is a tip of iceberg. Despite the availability of conventional treatments like Metformin, achieving optimal glycemic control in T2DM remains a challenge for many patients. Additionally, concerns regarding side effects and long-term sustainability of pharmacological interventions signifies the need for exploring alternative therapies. Though there are so many ongoing and completed studies on efficacy of Ayurvedic management of DM, most of them shows is effective in reducing the subjective parameters and no much change is observed in FBS, PPBS and is recommended to carry out the study in a larger number of patients. Investigating the efficacy of Chandrakala gutika in comparison to Mamajjaka Ghanavati offers an opportunity to diversify treatment options and potentially improve outcomes. Therefore, keeping all these facts in mind, it has been decided to conduct a clinical study entitled as “RANDOMISED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF CHANDRAKALA GUTIKA AND MAMAJJAKA GHANAVATI IN THE MANAGEMENT OF MADHUMEHA WITH SPECIAL REFERENCE TO DIABETES MELLITUS TYPE II”
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient aged between 30 to 65 years
- •Patient having symptoms of Madhumeha
- •Patient with FBS in range of 126mg/dl to 250mg/dl and PPBS in range of 200mg/dl to 350 mg/dl or both and HbA1c less than 10%
- •Patient consuming oral-hypoglycemic agents for a duration more than 1 year and having poor glycemic control
- •Patient with chronicity less than 5 years
- •Patient with willingness to participate in the study and provide informed consent.
排除标准
- •Pregnant and lactating women
- •Patient with type 1 diabetes
- •Patient with FBS more than 250mg/dl PPBS more than 350 mg/dl
- •Patients with Madhumeha upadrava or asadhya laxana
- •Patients with DM 2 on insulin therapy and Drug induced diabetes mellitus
- •Patients with hepatic impairment.
- •Uncontrolled hypertension.
结局指标
主要结局
The primary outcome of the study will be the change in FBS/PPBS levels from baseline to the end of the treatment period.
时间窗: Baseline to the end of the treatment period.
次要结局
- Secondary outcomes will include changes subjective parameters, HbA1c, liver function tests, renal function tests, and incidence of adverse events(Baseline, 45th day ,end of the treatment period.)
研究者
Chinmayi MK
National Institute of Ayurveda, Deemed to be university, Jaipur