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

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. - nill

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084318
Enrollment
60
Registered
2025-04-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Qurs-i-Kafur 10.5 grams will be given in thre divided doses(each tablet will contain 875mg) for 90 days.: It is a classical unani formulation taken from Al Qabadeen. The formulation co

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1) 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

Exclusion criteria: 1) Pregnant and lactating mothers. 2) 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

Design outcomes

Primary

MeasureTime frame
1)HbA1C 2)Fasting blood glucose levels 3)2-Hour PPBG levels 4)Fasting urine for glucose and ketones estimation 5)Mean blood glucose levelsTimepoint: 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

MeasureTime frame
A)Arbitary scale for the evaluavation of the subjective parameters which include 1)Polydypsia 2)Polyuria 3)Polyphagia 4)Loss of weight 5)Loss of libido 6)Giddiness 7)Nocturia 8)Fatigue 9)Burning sensation in palms and soles 10)VAS for the Pain B)Lipid ProfiLe,CBC with ESR,LFT,KFT,Na+,K+ and ECG C)Assessement of Quality of life with MDQoL-17Timepoint: A)Subjective parameters are to be evaluated at baseline,15th,30th,45th,60th,75th and 91ist day B) Lipid Profile,CBC with ESR,LFT,KFT,Sodium, potassium and ECG at the baseline and 91ist day of the study. C)Assessement of Quality of life with MDQoL-17 at baseline and 91ist day.

Countries

India

Contacts

Public ContactShugufta Hamid

Department of Moalajat Regional Research Institueof Unani Medicine ,Naseem bagh,University of Kashmir

hussainzaffar6@gmail.com7006021996

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026