A clinical trial to compare the effects of coded Unani research drug UNIM-221 with allopathic drug Metformin in patients with Diabetes Mellitus Type II

Phase 2

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complicationsHealth Condition 2: null- Ziabetus Sukkari Qism e Sani (Diabetes Mellitus Type II)

• Registration Number: CTRI/2013/10/004092
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 624

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢Improvement in signs and symptoms of diabetes mellitus <br/ ><br>â?¢Reduction in fasting and 2 hr plasma glucose level <br/ ><br>â?¢Decrease in HbA1c level by â?¥1% as compared to baseline <br/ ><br> <br/ ><br>Timepoint: 12 WEEKS

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessments for safety <br/ ><br>ï?· Improvement in the feeling of well-being of the patientTimepoint: 12 WEEKS