Effectiveness of Nishatriphala Ghan Capsule along with Metformin and Dietery & lifestyle changes in Managing Type 2 Diabetes Compared to Metformin and Lifestyle Changes Alone.

Phase 2

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

• Registration Number: CTRI/2024/08/072328
• Lead Sponsor: All India Institute Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

Patients :-

1)Of either gender in the age group of 26-60 years with classical signs and symptoms of Madhumeha (Type 2 DM).

2)Fulfilling the General Diagnostic Criteria (GDC) for diabetes mellitus along with dyslipidemia.

3)Willing to follw DSDL.

4)Diagnosed with T2DM(less than 5yrs)taking conventional medicine(Metformin)

5)With Blood Sugar Range-

Random blood sugar level (RBS) more than or equal to 200 mg/dl up to 300mg/dl or/and

Fasting blood sugar (FBS) more than or equal to 126 mg/dl up to 180 mg/dl or/and

Postprandial blood sugar (PPBS) more than or equal to 200 mg/dl up to 300 mg/dl or/and

Glycosylated haemoglobin range 6.5%-9.5%.

6)With Deranged Lipid Profile :-

Cholesterol Total more than200 mg/dl or/and

Triglycerides-TGL more than150 mg/dl or/and

Cholesterol HDL less than 40 mg/dl or/and

Cholesterol LDL more than100 mg/dl

Exclusion Criteria

1)Patients taking insulin either type 1 or type 2 DM.

2)Pregnant women/ lactating mothers.

3)Emergency conditions in cases of DM.

4)Complications of type 2 DM.

5)Patients with other diseases such as chronic liver disease, thyroid disorders, hypertension, CKD, heart diseases etc.

6)Patients were reported being hypersensitive to the proposed trial drug.

7)Patient taking only Ayurvedic medicine for Madhumeha.

8)Patient taking Conventional medicine for T2DM other than Metformin.

9)Participation in other clinical studies in the past 12 weeks.

10)For any reason, the investigator may consider a subject inappropriate for participation in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified