A study to compare efficacy and safety of coded Unani formulation UNIM D 2000 with Metformin in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)

Phase 3

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2021/07/034986
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM

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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of either gender in the age group of 18-65 years

2.HbA1c level >= 7%

3.Both newly diagnosed and known case of Type 2 DM may be included

4.Fasting plasma glucose levels between 126 and 200 mg/dl

Or

5.2hr plasma glucose levels between 200 and 300 mg/dl

And

6.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)

Iya (Fatigue)

Naqs al-Wazn (Loss of Weight)

Burning sensation in palm and soles

Sadr (Giddiness)

Naqs al-Shahwa (Loss of Libido)

Duf al Hadm

Bawl-e-raqueeque (lighter urine) with Kasrat

al-Bawl

Bawl-e-sufed (colourless urine) with Kasrat

al-Bawl

Exclusion Criteria

1.HbA1C >= 8%

2.Subjects with fasting plasma glucose level >200 mg/dl and /or PP plasma glucose level >300 mg/dl

3.Family history of Type 1 DM

4.Known cases of Metabolic syndrome

5.Diabetes Mellitus-Type 1 or subjects on Insulin therapy

6.Diabetes Mellitus associated with complications of Ketoacidosis

7.Patients on systemic corticosteroids/ disease modifying agents

8.Known cases of Ischemic Heart Disease/ Hyperlipidemia

9.Liver disorders SGPT >105 IU/L

10.Impaired renal function tests

11.Obese Subjects â?? BMI >35

12.Pregnant and lactating women

13.Known cases of Malignancy & Epilepsy

14.Known cases of any disorder requiring long-term treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II)Timepoint: 12weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessmentTimepoint: 12weeks