A Clinical trial to study the Healing effect of Gopyadi ghritha as topical application in patients with diabetic ulcer
Phase 3
- Conditions
- Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
- Registration Number
- CTRI/2023/04/051611
- Lead Sponsor
- GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURAERNAKULAM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Ulcer diagnosed by clinical examination in Type 2 diabetes mellitus.
2)As per Wagner classification, diabetic ulcer of Grade 1,Grade 2 and Grade 3
3)Ulcer size within 10 Ã? 10 cms.
4)Participants within the age limit of 30 â?? 70 years irrespective of gender.
5)Participants with written informed consent
Exclusion Criteria
1)Gangrenous ulcer.
2)Ulcer with severe foul smell and slough
3)Participants with known systemic disorders like tuberculosis, leprosy, anaemia and bleeding disorders
4)Participants with uncontrolled diabetes mellitus
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Assessment of healing effect by reduction in ulcer size calculated by area and depth <br/ ><br>Timepoint: assessment on 0th 7th 14th 21st 28th 35th and 42nd day
- Secondary Outcome Measures
Name Time Method 1)Formation of granulation tissue assessed by grading <br/ ><br>2) Epithelialisation assessed by grading <br/ ><br>3)Reduction in discharge assessed by grading <br/ ><br>4)Reduction in pain assessed by grading <br/ ><br> <br/ ><br>Timepoint: assessment on 0th 7th 14th 21st 28th 35th and 42nd day