aetiopathological and clinical study of Madhumeha with special reference to Type 2 Diabetes Mellitus

Phase 3

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2022/09/045137
• Lead Sponsor: School of Ayurveda Hospital DY Patil University

Brief Summary

This study is a randomised double blind contro parallel group aims to study aetiopathology of madhumeha and Upashayatmak effect of guduchi swaras on glucose level of diabetes patients . One group 50 patients given giloy swaras 15 ml x bd with honey and another group 50 patients control group given metformin -500mg xbd with water .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Inclusion Criteria – Patients between age group 30 to 60 years.
• Newly Diagnosed cases of Diabetes mellitus less than 6months FBS- 130-160 mg/dl and PP- 150- 220mg/dl HbA1c.

Exclusion Criteria

• Patients of age less than 20 years and above 60 years.
• Pregnant woman 3.
• Patients with serious disorders like MI, CHF, cirrhosis of liver, severe complicated DM.
• Patients taking drugs like corticosteroids, antidepressant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sample Size-100 patients	Time Points | Completion of trail- 2 Years | Duration of trail-90 days | Follow up-15 days | 30 days | 45 days | 60 days | 75 days | 90 days
Group-2	Time Points | Completion of trail- 2 Years | Duration of trail-90 days | Follow up-15 days | 30 days | 45 days | 60 days | 75 days | 90 days
Group A -50 patients and GroupB-50 patients	Time Points | Completion of trail- 2 Years | Duration of trail-90 days | Follow up-15 days | 30 days | 45 days | 60 days | 75 days | 90 days
Test- Paired T Test	Time Points | Completion of trail- 2 Years | Duration of trail-90 days | Follow up-15 days | 30 days | 45 days | 60 days | 75 days | 90 days
Wilcoxon matched pairs	Time Points | Completion of trail- 2 Years | Duration of trail-90 days | Follow up-15 days | 30 days | 45 days | 60 days | 75 days | 90 days
Signed rank test	Time Points | Completion of trail- 2 Years | Duration of trail-90 days | Follow up-15 days | 30 days | 45 days | 60 days | 75 days | 90 days

Trial Locations

Locations (1)

DY Patil university, School of Ayurveda hospital,; 🇮🇳 Mumbai, MAHARASHTRA, India

DY Patil university, School of Ayurveda hospital,

🇮🇳Mumbai, MAHARASHTRA, India

Dr Rekha

Principal investigator

9932080905

drsinghrekha@gmail.com