Health Condition 1: null- TYPE II DIABETES MELLITUS
Conditions
Interventions
Intervention1: Study Drug: A Polyherbal Unani Formulation (Powder): Patients will be givenUnani Formulation (Powder) in the dose of 6g
twice daily orally with water ½ hr before meals.
Control Interv
Sponsors
CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD
Eligibility
Inclusion criteria
Inclusion criteria: 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 1. 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. Burning sensation in palm and soles 9. Sadr (Giddiness) 10. Naqs al-Shahwa (Loss of Libido)
Exclusion criteria
Exclusion criteria: 1. Subjects with Fasting Plasma Glucose (FPG) level >150 mg/dl and /or PostprandialPlasma Glucose level >250 mg/dl 2. Diabetes Mellitus associated with complications of Ketoacidosis 3. Diabetes Mellitus Type-I/ Secondary Diabetes Mellitus/ 4.Patients on Insulin therapy 5. Significant Pulmonary/Cardiovascular/Hepato-renal dysfunction 6. Pregnant and lactating women
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 FPGand Postprandial Plasma Glucose (2-hPG) level 2. Decrease inHbA1c level by â?¥1% as compared to baseline Improvement in symptoms of ZayÄ?bÄ«á¹usSukkariQismSÄ?ni(Diabetes Mellitus Type 2) on Visual Analogue Scale (VAS)Timepoint: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of Safety 2. Adverse Effects (AEs) The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit and also by investigations (done at week 0 and 12). 3. Haemogram: Hb%, TLC, DLC, ESR 4. LFTs: S. Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase 5. KFTs: Serum Creatinine, Blood Urea Nitrogen (BUN) 6. Urine Examination: Routine & Microscopic Timepoint: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk | — |
Countries
India
Contacts
Public ContactProf Qamar Uddin
CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD
Outcome results
None listed