Clinical study to evaluate safety and efficacy of Unani formulation Safoof-e-Ziabetus Dulabi in Type 2 Diabetes Mellitus

â??A Randomized Standard Controlled Clinical Study to Compare the Safety and Efficacy of a Unani Formulation Safoof-e-Ziabetus Dulabi with Metformin in DhayÄ?bÄ«á¹us HÄ?rr Qism ThÄ?nÄ« (Type 2 Diabetes Mellitus)â?? - T2DM

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020838

Enrollment

120

Registered

2019-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Study Drug: Safoof-e-Ziabetus Dulabi: Patients will be given Unani compound Formulation (Powder) in the dose of 6g twice daily orally with water Â½ hr before meals. Intervention2: Stu

Eligibility

Inclusion criteria

Inclusion criteria: i) Patients of any sex in the age group between 25 and 60 years ii) Fasting Plasma Glucose levels between 126 and 175 mg/dL or Post pandrial Plasma Glucose levels between 200 and 250 mg/dL (2 hours after ingestion of 75 gm of glucose in 300 ml of water) or iii)HbA1C level>=6.5 % and iv) Presence of any of the following symptoms and signs of diabetes mellitus: 2. Utash Mufrit(Polydipsia) 3. Kasrat al-Bawl (Polyuria) 4. Kasrat al-Ishtiha (Polyphagia) 5. Bawl Layli (Nocturia) 6. Iâ??ya(Fatigue) 7. Naqs al-Wazn (Loss of Weight) 8. Sozish-e-Kaf-e-Dast-o-Pa (Burning sensation in palm and soles) 9. Sadr (Giddiness) 10. Naqs al-Shahwa (Loss of Libido

Exclusion criteria

Exclusion criteria: Any of the following: 1. Subjects with fasting plasma glucose level >175 mg/dl and /or 2. Post-pandrial plasma glucose level >250 mg/dl 3. Subjects on Insulin therapy 4. Diabetes Mellitus-Type I 5. Secondary Diabetes Mellitus 6. Diabetes Mellitus associated with complications of Ketoacidosis. 7. Ischemic Heart Disease/ Hypertension/ Hyperlipidemia 8. Liver disorders 9. Impaired Renal function tests 10. Obese Subjects â?? BMI >30 11. Pregnant and lactating women 12. Any infective disorder requiring long-term treatment 13. Drug addicts/ Alcoholics 14. Malignancy/ Epilepsy

Design outcomes

Primary

Measure	Time frame
Assessment of Response to Therapy 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: 1. Reduction in FPG and Postprandial Plasma Glucose (2-h PG) level 2. Decrease inHbA1c level by â?¥1% as compared to baseline Improvement in symptoms of DhayÄ?bÄ«á¹us HÌ£Ä?rr Qism ThÄ?nÄ« (Type 2 Diabetes mellitus) on Visual Analogue Scale (VAS) Timepoint: At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.	—

Measure

Time frame

Assessment of Response to Therapy 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: 1. Reduction in FPG and Postprandial Plasma Glucose (2-h PG) level 2. Decrease inHbA1c level by â?¥1% as compared to baseline Improvement in symptoms of DhayÄ?bÄ«á¹us HÌ£Ä?rr Qism ThÄ?nÄ« (Type 2 Diabetes mellitus) on Visual Analogue Scale (VAS) Timepoint: At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.

—

Secondary

Measure	Time frame
Haematological and biochemical assessments for safety. i)Serious Adverse Event (SAE) ii)Adverse Event / Adverse Drug Reaction (AE/ADR) iii)Laboratory Abnormalities as AEs Haemogram, Liver Function Test(LFT), Kidney Function Test(KFT), Lipid profile, Thyroid profile, Complete Urine Examination (CUE): Routine & Microscopic, Erythrocyte Sedimentation Rate(ESR), Electrocardiogram(ECG) Timepoint: The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit i.e At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk and also by investigations (done at week 0 and 12).	—

Measure

Time frame

Haematological and biochemical assessments for safety. i)Serious Adverse Event (SAE) ii)Adverse Event / Adverse Drug Reaction (AE/ADR) iii)Laboratory Abnormalities as AEs Haemogram, Liver Function Test(LFT), Kidney Function Test(KFT), Lipid profile, Thyroid profile, Complete Urine Examination (CUE): Routine & Microscopic, Erythrocyte Sedimentation Rate(ESR), Electrocardiogram(ECG) Timepoint: The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit i.e At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk and also by investigations (done at week 0 and 12).

—

Countries

India

Contacts

Public ContactProf Dr M A Faroqui

Govt. Nizamia Tibbi College

drfaroqui@gmail.com8309160124

Outcome results

None listed

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