Evaluation of Comparative efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath versus standard treatment (Tab Metformin) in the management of Diabetes Mellitus Type II (Prameha): A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To assess and compare the efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath and Tab Metformin over Blood sugar levels (Fasting and Post prandial), Urine Sugar level in Diabetes Mellitus Type II
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 48 days treatment period and at Day follow up period baseline, 16th and 48th day.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to give written informed consent Patient with either sex having age between 20 to 60 years Patients recently diagnosed for uncomplicated NIDDM (less than 6 months) and having 1 Fasting blood sugar level 126 to 200 mg per dl 2 Post meal blood sugar level 140 to 300mg per dl Patients with type-2 DM for 6 months but not taking any other anti-hypoglycemic drugs Diabetic Patients suffering from controlled hypertension Systolic blood pressure not more than 140 mmHg or an average Diastolic Blood Pressure not more than 90 mmHg Patient fit for Vasti Karma as per the Ayurvedic classics Newly Diagnosed Diabetic patients who are not willing for Allopathic medications.
排除标准
- •Patients suffering from IDDM (Insulin dependent diabetes mellitus) and patients with Type-2 Diabetes on insulin therapy Patients suffering from Juvenile Diabetes or Gestational diabetes (2024 ICD-10-CM Diagnosis Code O24.4) Impaired glucose tolerance (2024 ICD-10-CM Diagnosis Code R73.02) DM with complications Retinopathy, Nephropathy, neuropathy, previous history of coma Patients suffering from any current acute illness, uncontrolled hypertension Pregnant and Lactating women Anorectal Pathologies.
结局指标
主要结局
To assess and compare the efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath and Tab Metformin over Blood sugar levels (Fasting and Post prandial), Urine Sugar level in Diabetes Mellitus Type II
时间窗: at baseline | 16 day | 48 day
次要结局
- Comparison and assessment of efficacy of Phalatrikadi Vasti followed by Phalatrikadi Kwath and Tab Metformin over Blood sugar levels (Fasting and Post prandial), Urine Sugar level in Diabetes Mellitus Type II(at baseline)
研究者
Dr Prasad Rukminikant Mirge
Mahatma Gandhi Ayurveda College Hospital and Research Centre salod wardha, Maharashtra, India 442001