To See The Effect of Bhunimbadi Churna And Nyagrodhadi Churna In The Management Of Madhumeha (Type-2 Diabetes Mellitus)

Phase 3

Completed

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

• Registration Number: CTRI/2021/12/038915
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-17
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

1.Patients of either gender in the age group of 25-65 years

2. Patients with classical signs and symptoms of Madhumeha (Avarn-janya prameha)

3. Inclusion criteria based on blood Investigations

Fasting blood sugar (FBS) >126 mg/dl up to 300 mg/dl, and

Patients with random blood sugar level (RBS) >200 up to 450mg/dl, or

Postprandial blood sugar (PPBS) >200 mg/dl up to450 mg/dl, and

Glycosylated haemoglobin > 6.5%-16%

NOTE: In the above given criteria there is one should be present and HbA1c Must be > 6.5%.

Newly /early diagnosed cases to be included as per following criteria:

Patients who are not taking any conventional

medicine for more than two months, whose sugar

levels are raised and fall. within the inclusion criteria mentioned above and are willing to take Ayurvedic treatment

Patient accidently diagnosed in routine check-up or when appeared with other complaints in the hospital.

Early diagnosed diabetic patients (less than 2 year of diabetic history) and not taking any

pharmacological drugs since last two months.

Exclusion Criteria

1. Patients with acute/chronic liver disease with elevated liver enzymes.

2. Patients with history of alcohol abuse.

3. Patients having insulin dependent DM (type 1) and receiving insulin

4. Chronic complications like microvascular and macrovascular derangements.

5. Hyper or hypothyroidism

6. Patients reporting to be hypersensitive to any of the proposed trial drugs.

7. Pregnant women/ lactating mothers

8. Participation in other clinical studies in past 12 weeks.

9. Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics)

10. Patients Fails to Fall in Inclusion criteria of Blood sugar level.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reduction in HBA1C level <br/ ><br>2.Improvement in Signs and Symptoms of Madhumeha <br/ ><br>Timepoint: 90-120 Days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Reduction in Blood sugar fasting, post prandial, random (in mg/dl) <br/ ><br>2.Improvement in Quality of Life in DMT2 Patients <br/ ><br>Timepoint: 90-120 Days