A comparison between Nimbadi Ghana Vati and Phalatikadi Ghana Vati in Madhumeha (Diabetes mellitus 2).

Phase 2

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

• Registration Number: CTRI/2023/04/051750
• Lead Sponsor: ALL INDIA INSTITUTE OF AYURVEDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

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

Inclusion Criteria

1.Either gender in the age group 30-60 yrs with classical signs and symptoms of Madhumeha.

2.Patients fulfilling the general diagnostic criteria for diabetes mellitus.(as per diabetic protocol by MOA/AIIA).

3.RBS more than or equal to 200 to 450 mg/dl.

4.FBS more than or equal to 126 to 350 mg/dl.

5.PPBS more than or equal to 200 to 450 mg/dl.

6.Glycosylated haemoglobin more than or equal to

6.5% to 15%.

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

- patients accidentally diagnosed in routine check-up or when appeared with other complaints in the hospital.

- early diagnosed diabetic patients ( < 3yrs of diabetes) and not taking any pharmacological drugs.

- patients who used to take conventional medicines and stopped taking them for 3 months & were willing to take Ayurvedic Medicines.

Exclusion Criteria

1.Patients having insulin dependent DM(type1) and receiving OHA.

2.Age <30yrs and >60yrs, pregnant women and lactating mothers.

3.Excessive blood sugar:FBS >350mg/dl and PPBS >450mg/dl.

4.Emergency conditions in cases of DM, chronic complications and patients with other diseases such as chronic liver diseases, thyroid disorders, hypertension, CKD, heart diseases etc.

5.Patients who were not fit for yoga.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the level of Glycosylated haemoglobin (HbA1c). <br/ ><br>Timepoint: (DAY-0)(DAY-7)(DAY-14)(DAY-30)(DAY-45)(DAY-60)(DAY-75)(DAY-90) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Improvement in the signs and symptoms of Madhumeha after 90days. <br/ ><br>2.Reduction in the level of FBS & PPBS at 30th,60th and 90th day of the study . <br/ ><br>3.Improvement in the quality and quantity of urine after 90 days. <br/ ><br>4. Improvement in the quality of life after a period of 90days. <br/ ><br>Timepoint: (DAY-0)(DAY-7)(DAY-14)(DAY-30)(DAY-45)(DAY-60)(DAY-75)(DAY-90)