TO study the effects of a compound unani formulation (Qurs-i-Kafur) in the patients of Type -2 Diabetes.

Phase 2

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2025/04/084318

Lead Sponsor: Central Council for Research in Unani Medicine (CCRUM),110058 New Delhi

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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%.

Exclusion Criteria

1. Pregnant and lactating mothers.
1. 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3)2-Hour PPBG levels	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	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	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	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	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)

Secondary Outcome Measures

Name	Time	Method
A)Arbitary scale for the evaluavation of the subjective parameters which include	1)Polydypsia

Trial Locations

Locations (1): Regional Research Institute of Unani Medicine(RRIUM)
🇮🇳
JAMMU, & KASHMIR, India
Regional Research Institute of Unani Medicine(RRIUM)
🇮🇳JAMMU, & KASHMIR, India
DrZaffar Hussain
Principal investigator
07006021996
hussainzaffar6@gmail.com