Assessment of a polyherbal unani formulation in comparison to standard treatment for type 2 diabetes mellitus (ziabetus): A randomized control clinical trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is an open label, randomized, parallel group, active controlled trial for the evaluation and comparison of PHUF ziabetus powder and metformin in type 2 diabetes mellitus patients in the respect of safety and efficacy. PHUF ziabetus powder will be given orally 5 gram twice a day in empty stomach for 90 days in 30 patients. Control group will be treated with Metformin 500mg . Dose will be one tablet twice a day after meal for 90 days in 30 patients. The study will be conducted in Government Tibbi College and Hospital Kadam Kuan , Patna Bihar.
Primary outcomes will be reduction in polyuria, polydipsia, tiredness and burning sensation in palms or soles. Body weight will be constant or increased.
There will be also reduction in fasting plasma glucose and post prandial plasma glucose. HbA1c comparison will be done be before and after trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjective Parameters are Polyuria, Polydipsia, Tiredness/ Fatigue, weight loss and burning sensation in palms or soles.
- •Objective Parameters are fasting plasma glucose range 126-150 mg/dl, post prandial plasma glucose range 200- 250 mg/dl and HbA1c range 6.5 to 8 percent.
排除标准
- •Severe anemia ( Hemoglobin less than 8gram percent in females and hemoglobin less than 10 gram percent in males).
- •Uncontrolled hypertension and CAD patients.
- •Any chronic major illness like tuberculosis, CVA, thyroid disease.
- •Pregnant and lactating women.
- •Chronic hepatic and renal disorders patients.
- •Patients having any type of malignancy, autoimmune and immunodeficiency disorders.
- •Patients with congenital anomaly, mentally retarded and bed ridden.
研究者
Dr Md Zahid
Government Tibbi College and Hospital Kadam Kuan Patna