Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: null- Ziabetus Sukkari Qism e Sani (Diabetes Mellitus Type II)
Conditions
Interventions
Intervention1: UNIM-221: � 10 gm BD orally with water ½ hr before meals.
Duration of therapy: 12 weeks
Control Intervention1: Metformin: 500 mg BD orally with water ½ hr before meals.
Duration of
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex in the age group of 18-65 years. 2. Fasting plasma glucose levels between 126 and 150 mg/dl or 3. 2hr plasma glucose levels between 200 and 250 mg/dl (2 hours after ingestion of 75 gm of glucose in 300 ml of water) or 4. HbA1c level >=6.5% and 5. Presence of any of the following symptoms and signs of diabetes mellitus: • Utash mufrit (Polydipsia) • Kasrat al-Bawl (Polyuria) • Kasrat al-Ishtiha (Polyphagia) • Bawl Layli (Nocturia) • Iâ??ya (Fatigue) • Naqs al-Wazn (Loss of Weight) • Burning sensation in palm and soles • Sadr (Giddiness) • Naqs al-Shahwa (Loss of Libido)
Exclusion criteria
Exclusion criteria: • Subjects with fasting plasma glucose level 150 mg/dl and /or PP plasma glucose level 250 mg/dl • Subjects on Insulin therapy • Diabetes Mellitus-Type I • Secondary Diabetes Mellitus • Diabetes Mellitus associated with complications of Ketoacidosis • Patients on systemic corticosteroids/ disease modifying agents • Ischemic Heart Disease/ Hypertension/ Hyperlipidemia • Liver disorders SGPT 105 IU/L • Impaired Renal function tests • Anemia Hb 8 gm/dl in Males and Hb 6 gm/dl in females • Obese Subjects â?? BMI 30 • Pregnant and lactating women • Drug addicts/ Alcoholics • Malignancy/ Epilepsy Any infective disorder requiring long-term treatment • Patient on any other treatment including use of alternative medicine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Improvement in signs and symptoms of diabetes mellitus â?¢Reduction in fasting and 2 hr plasma glucose level â?¢Decrease in HbA1c level by â?¥1% as compared to baseline Timepoint: 12 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and biochemical assessments for safety ï?· Improvement in the feeling of well-being of the patientTimepoint: 12 WEEKS | — |
Countries
India
Contacts
Public ContactDr Abdul Hannan
Central Council for Research in Unani Medicine (CCRUM)
Outcome results
None listed