A Clinical Study to Evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Zayabitus Sukkari Qism Sani (Diabetes Mellitus Type 2)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of Response to Therapy
研究概览
简要总结
Diabetes mellitus is a metabolic disorders of multiple etiology, characterized by hyperglycemia with disturbance of carbohydrates, fats, and protein metabolism resulting from defects in insulin secretion and insulin action. The cost of diabetes care is high and is escalating worldwide. It is estimated 673 billion USD spent due to diabetes (2). The number of people withdiabetes mellitus is increasing in every country, half of the people with diabetes mellitus do not know they have it. It is estimated by International Diabetes Federation (IDF) that193 million people with diabetes are undiagnosed and are therefore more at risk of developing complications. One in 15 adults is estimated to have glucose tolerance, and one in 7th birth is affected by gestational diabetes mellitus (GDM). Number of men was affected 215.2 million and women 199.5 million in 2015, half of the people who die from diabetes mellitus are under the age of 60 year. This disorder is frequently associated with long term complication such as atherosclerosis Ischemic Heart Disease (IHD) Chronic renal failure, diabetes ketoacidosis. Worldwide prevalence of diabetes was estimated to 415 million in 2015 but in India alone 69.1 million and in China 114 million people. On account of its complication, it is leading cause of morbidity and mortality. Due to these complications, diabetes mellitus has become global problem despite of advancement of modern science. Several anti-diabetics agents are already being used such as glibenclamide,gliclazide, glimepiride, metformin, etc. But these drugs are associated with certain side effects like purpura, disulfiram-like reaction, flu like symptoms, lactic acidosis, hepatic dysfunction.
There are a number of classical compound formulations used for the management of Diabetes Mellitus in Unani system of medicine. To validate safety and efficacy of a polyherbal formulation comprising Gurmarbuti, Gilo Khushkand Maghz TukhmJamun, the present study entitled “**A Clinical Study to Evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Zayabitus Sukkari Qism Sani (Diabetes Mellitus Type 2)â€**has been designed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •i) Patients of any sex in the age group between18 and 65 years ii) Fasting PlasmaGlucose levels between 126 and 150 mg/dL or PPPlasmaGlucoselevels between 200and 250 mg/dL (2 hours after ingestion of 75 gm of glucose in 300 ml of water) or HbA1C level≥6.5 %(3) and
- •Presence of any of the following symptoms and signs of diabetes mellitus:
- •Utash Mufrit(Polydipsia)
- •Kasrat al-Bawl (Polyuria)
- •Kasrat al-Ishtiha (Polyphagia)
- •Bawl Layli (Nocturia)
- •I’ya(Fatigue)
- •Naqs al-Wazn (Loss of Weight)
- •Burning sensation in palm and soles
- •Sadr (Giddiness)
- •Naqs al-Shahwa (Loss of Libido).
排除标准
- •Subjects with Fasting Plasma Glucose (FPG) level >150 mg/dl and /or PostprandialPlasma Glucose level >250 mg/dl
- •Diabetes Mellitus associated with complications of Ketoacidosis
- •Diabetes Mellitus Type-I/ Secondary Diabetes Mellitus/ 4.Patients on Insulin therapy
- •Significant Pulmonary/Cardiovascular/Hepato-renal dysfunction
- •Pregnant and lactating women.
结局指标
主要结局
Assessment of Response to Therapy
时间窗: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk
Clinical assessment will be done at 2, 4, 6, 8, 10, and 12 weeks and the response to treatment will be assessed using the following parameters:
时间窗: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk
1.Reduction in FPGand Postprandial Plasma Glucose (2-hPG) level
时间窗: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk
2.Decrease inHbA1c level by ≥1% as compared to baseline
时间窗: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk
Improvement in symptoms of ZayÄbÄ«á¹usSukkariQismSÄni(Diabetes Mellitus Type 2) on Visual Analogue Scale (VAS)
时间窗: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk
次要结局
- 1. Assessment of Safety(2. Adverse Effects (AEs))
