A clinical study to evaluate the effect of a Unani Polyherbal formulation in the treatment of Diabetes Mellitus Type 2

Phase 2

Completed

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

• Registration Number: CTRI/2022/09/045501
• Lead Sponsor: Ayurvedic and Unani Tibbia College and Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Patient with Fasting Blood sugar more than or equal to 126mg/dl,

2. Post prandial Blood sugar more than or equal to 200 mg/dl, 3.

Random Blood sugar more than 200 mg/dl with clinical features of diabetes,

4. Patient with HbA1c more than or equal to 6.5,

5. Patient willing to participate in the study, sign the understood consent form and ready to follow the instructions

Exclusion Criteria

1. Patient with a Fasting Blood sugar of more than 400 mg/dl,

2. Pregnant and lactating women,

3. Patient with Anaemia (Hb <10gm/dl),

4. Hepatic and Renal impairment,

5. Uncontrolled Infection (TB, UTI, etc.) 6. Malignancy or taking Chemotherapy,

7. Patient having Diabetes Insipidus,

Diabetes Mellitus Type 1, Cushings

syndrome and Acromegaly,

8. Patient taking any medication which

raises the blood sugar level e.g;

Steroids , Diuretics , Oral

contraceptive pills etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Develop a safe, efficacious <br/ ><br> and cost-effective drug for <br/ ><br> Type 2 Diabetes Mellitus on <br/ ><br> scientific parameters. <br/ ><br>2.Evaluate the hypoglycaemic <br/ ><br> control of Test drug for <br/ ><br> acheiving a safe range of <br/ ><br> blood sugar on HbA1c <br/ ><br> parameter. <br/ ><br>3.Evaluate the efficacy of <br/ ><br> test drug in comparison to <br/ ><br> a standard hypoglycaemic <br/ ><br> agent.Timepoint: 1.Clinical examination and subjective evaluation would be done at baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks and 13 weeks. <br/ ><br>2.To evaluate efficacy- Blood sugar (F and PP) at the baseline, 1 Month, 2 Months, 3 Months. HbA1c at baseline and 3 months. <br/ ><br>3.To Evaluate safety- Haemogram, LFT and KFT at the baseline, 8th day and after 13 weeks.

Secondary Outcome Measures

Name	Time	Method
Evaluate the effect of Test drug on Insulin resistance.Timepoint: At the baseline, 1 month, 2 months and 3 months.