Clinical study for safety and effectiveness of Unani formulation in Diabetes Mellitus

Phase 2

Recruitment & Eligibility

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

PPPlasmaGlucoselevels between 200and 250 mg/dL

(2 hours after ingestion of 75 gm of glucose in 300 ml of water)

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

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

Primary Outcome Measures

Name	Time	Method
Assessment of Response to Therapy <br/ ><br>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: <br/ ><br>1.Reduction in FPGand Postprandial Plasma Glucose (2-hPG) level <br/ ><br>2.Decrease inHbA1c level by â?¥1% as compared to baseline <br/ ><br>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 Outcome Measures

Name	Time	Method
1. Assessment of Safety <br/ ><br>2. Adverse Effects (AEs) <br/ ><br>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). <br/ ><br>3. Haemogram: Hb%, TLC, DLC, ESR <br/ ><br>4. LFTs: S. Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase <br/ ><br>5. KFTs: Serum Creatinine, Blood Urea Nitrogen (BUN) <br/ ><br>6. Urine Examination: Routine & Microscopic <br/ ><br>Timepoint: at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk