Management of Diabetic Foot Ulcers using comprehensive ayurvedic treatment protocol.

Phase 2

• Conditions: Health Condition 1: E106- Type 1 diabetes mellitus with other specified complicationsHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2022/09/045716
• Lead Sponsor: Ayurveda Mahavidyalaya College and Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

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

Inclusion Criteria

1. Subjects who are Madhumehi (Diabetic) with the clinical features of Duṣṭa vra�a (Diabetic

foot ulcer) with Type I or Type II Diabetes Mellitus will be included.

2. Subjects will be selected irrespective of age and gender.

3. Subjects with or without Hypertension will also be included.

Exclusion Criteria

1. Subjects with Madhumehajanya Duṣṭa vra�a with associated features of gangrene will be

excluded.

2. Subjects with Madhumehajanya Duṣṭa vra�a involving bone will be excluded.

3. Subjects with other systemic diseases like HIV, HBsAg, any Malignancy, DVT, Tuberculosis

etc will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of the proposed comprehensive treatment protocol in the management of Madhumehajanya Dushta VranaTimepoint: Outcomes will be assessed: <br/ ><br>1. Before starting the intervention <br/ ><br>2. After 3rd day (After Deepana and Pachana) <br/ ><br>3. After 4th day (After Sadhyo Virechana) <br/ ><br>4. Here onwards Every 5 days once for 1 month(study period) or till complete healing of the wound (whichever is earlier) <br/ ><br> <br/ ><br>Follow up is done once a week for 1 month after completion of the treatment duration or complete healing of the wound (whichever is earlier)

Secondary Outcome Measures

Name	Time	Method
To formulate a comprehensive treatment protocol for the management of <br/ ><br>Madhumehajanya duṣṭa vraá¹�a vis-� -vis Diabetic foot ulcer. <br/ ><br>Timepoint: 5 days