An open labelled non-randomized phaseII clinical trial to evaluate the effectiveness of Mezhugu kalimbu(External therapy)in the management of Narambu kiranthi (varicose Ulcer)
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Dr DHINAKARAN T
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.
Overview
Brief Summary
This study is an open labelled non randomised phase II clinical trial to evaluate the effectiveness of MEZHUGU KALIMBU ( external therapy) in the management of NARAMBU KIRANTHI( varicose ulcer).This trial drug will be an external application for daily 15 days in 40 patients.The trial period of 24 moths will be carried out in government Siddha medical College and hospital, palayamkottai, Tirunelveli 627002, Tamilnadu,The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.In clase of any adverse events is noticed and it will be referred to pharmacovigilence department,and further management of patients will be given OPD patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient who are willing to take external therapy alone Patient who are willing for admission and stay in IPD or willing to attend OPD.
- •Patients who are willing to give blood samples for laboratory investigations.
Exclusion Criteria
- •Pregnant and lactating women Severe renal, hepatic, cardiac disease Malignant ulcers Uncontrolled diabetes Syphilitic ulcers Ischemic ulcers Traumatic ulcers.
Outcomes
Primary Outcomes
The outcome of the study will be assessed by reduction in the margins(size) of the wound and better healing.
Time Frame: 15 days
Secondary Outcomes
No secondary outcomes reported
Investigators
DHINAKARAN T
Government siddha medical College and hospital, palayamkottai