Clinical study to evaluate the safety and therapeutic effects of Qurs-i-Kafur in the management of Dhayabitus Harr(Type-2 Diabetes mellitus):Randomized,Single Blind,Standard Controlled Study.
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
- 3)2-Hour PPBG levels
研究概览
简要总结
Diabetes mellitus refers to a group of common metabolic disorders that shares the phenotype of hypergiycemia.Several distinct tyoes of Diabetes mellitus are caused by the complex interaction of genetics and environmental factors.Diabetes is a major health issue that has reached alarming levels.Today more than half a billion people are living with the Diabetes mellitus and it is one of the fastest growing global health emergencies of 21th century.The increased prevalence of the disease together with it’s complications like end stage renal disease,non -traumatic lower extremity amputations,adult blindness and many more make diabetes a nasty disease,as these complications lead to the increased morbidity,disability,mortality and present a great threat for the economies of all the countries especially the developing ones .Therefore it the need of an hour to bring the altrenative medicine into the practice,so that a safer and effective way of treatment can be established.Our Unani scholars have discribed Diabetes in various unani books and a number of single and compound formulations have been used by them which include,Tukhm-i-Hulba,Kalonji,Aqaqiya,Gul-i-surkh.Qurs-i- Dhayabitus,Qurs -i-Tabasheer,Qurs-i-Gulnar,Safoof-i-Hindi etc .In addition to this,one of the drugs that has been mentioned in the Unani texts,is Qurs-i-Kafur,hence this trail titled as Clinical study to evaluvate the safety and efficacy of Qurs-i-Kafur, in the management of Dhayabitus Harr ( Type -2 Diabetes mellitus) a randomized single blind standard controlled study has to be conducted to evaluate the Qurs-i-kafur,on the scienticfic parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 18-70 years 2) Patients irrespective of gender 3) Fasting plasma glucose levels between 126-150 mg/dl OR 4) 2-hour post-prandial plasma glucose level between 200-250 mg/dl OR 5) HbA1c level between 6.5-8%.
排除标准
- •Pregnant and lactating mothers.
- •Subject with the fasting glucose level more than 150 mg/dl 3)Post-prandial glucose level more than 250 mg/dl 4) HbA1c more than 8 5) Subjects on insulin therapy 6) Known cases of Type-2 Diabetes mellitus with complications of ketoacidosis, Diabetic Nephropathy, Diabetic retinopathy 7) Known cases of Type-1 Diabetes mellitus / Gestational Diabetes mellitus 8) Known cases of significant pulmonary, cardio-vascular, hepato- renal dysfunction 9) Uncontrolled hypertension 10) Known cases of polycythemia, iron deficiency aneamia, hemoglobinopathies 11) Patient not willing to attend treatment schedule regularly 12)Patients on double or triple combination therapy for Type-2 Diabetes mellitus.
结局指标
主要结局
3)2-Hour PPBG levels
时间窗: 1)HbA1C (At baseline And 91ist day of the Study) | 2)Fasting blood glucose levels(at baseline,15th,30th,45th,60th,75th and 91ist day of the study ) | 3)2-Hour PPBG levels(At baseline,15th day,30th day,45th day,60th day,75th day and 91ist day of the study) | 4)Fasting urine for glucose and ketones estimation (At baseline and 91ist day of the study) | 5)Mean blood glucose levels(At Baseline and 91ist day of the study)
1)HbA1C
时间窗: 1)HbA1C (At baseline And 91ist day of the Study) | 2)Fasting blood glucose levels(at baseline,15th,30th,45th,60th,75th and 91ist day of the study ) | 3)2-Hour PPBG levels(At baseline,15th day,30th day,45th day,60th day,75th day and 91ist day of the study) | 4)Fasting urine for glucose and ketones estimation (At baseline and 91ist day of the study) | 5)Mean blood glucose levels(At Baseline and 91ist day of the study)
2)Fasting blood glucose levels
时间窗: 1)HbA1C (At baseline And 91ist day of the Study) | 2)Fasting blood glucose levels(at baseline,15th,30th,45th,60th,75th and 91ist day of the study ) | 3)2-Hour PPBG levels(At baseline,15th day,30th day,45th day,60th day,75th day and 91ist day of the study) | 4)Fasting urine for glucose and ketones estimation (At baseline and 91ist day of the study) | 5)Mean blood glucose levels(At Baseline and 91ist day of the study)
4)Fasting urine for glucose and ketones estimation
时间窗: 1)HbA1C (At baseline And 91ist day of the Study) | 2)Fasting blood glucose levels(at baseline,15th,30th,45th,60th,75th and 91ist day of the study ) | 3)2-Hour PPBG levels(At baseline,15th day,30th day,45th day,60th day,75th day and 91ist day of the study) | 4)Fasting urine for glucose and ketones estimation (At baseline and 91ist day of the study) | 5)Mean blood glucose levels(At Baseline and 91ist day of the study)
5)Mean blood glucose levels
时间窗: 1)HbA1C (At baseline And 91ist day of the Study) | 2)Fasting blood glucose levels(at baseline,15th,30th,45th,60th,75th and 91ist day of the study ) | 3)2-Hour PPBG levels(At baseline,15th day,30th day,45th day,60th day,75th day and 91ist day of the study) | 4)Fasting urine for glucose and ketones estimation (At baseline and 91ist day of the study) | 5)Mean blood glucose levels(At Baseline and 91ist day of the study)
次要结局
- A)Arbitary scale for the evaluavation of the subjective parameters which include(1)Polydypsia)