Analytical Study & Randomized Comparative Trial of Gomutra Ark Bhavita Godhuma in the Management of Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
This study aims to evaluate the effect of Gomutra Ark Bhavita Godhuma, a cow urine processed wheat formulation, in the management of Type 2 Diabetes Mellitus. The study is divided into two phases. Phase 1 includes analytical testing of treated wheat to assess nutritional changes, carbohydrate fraction, starch and protein digestibility, mineral content, and antidiabetic enzyme inhibition. Phase 2 is a randomized open label comparative clinical trial with two groups of newly diagnosed Type 2 Diabetes Mellitus patients. The trial group will receive Gomutra Ark Bhavita Godhuma as diet along with Madhumehari Churna. The comparative group will receive only Madhumehari Churna with their normal diet. A total of 80 participants, 40 in each group, will be studied for a period of 90 days. Primary outcomes include changes in fasting blood sugar, postprandial blood sugar, and HbA1c levels. Secondary outcomes include analytical findings related to glycemic properties. The study aims to provide scientific evidence on whether Gomutra Ark Bhavita Godhuma can serve as an effective dietary support in the management of Type 2 Diabetes Mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with age group
- •70 years, newly diagnosed Type 2 Diabetes Mellitus of either sex. FBS 126mg/dl – 200mg/dl and PPBS 180mg/dl – 280mg/dl and HbA1c range between 6.5%.
- •10% Patient willing to participate in the study.
排除标准
- •Patient suffering from Type 1 Diabetes Mellitus and other complications of diabetes such as Diabetic neuropathy, Diabetic Retinopathy, Ischemic heart disease.
- •Patient with cardiovascular disease and other systemic illness.
- •Pregnant women and lactating mother.
- •Patients taking allopathic medications.
研究者
Swati
National Institute of Ayurveda, DeNoVo JAIPUR
