CTRI/2018/04/013087RecruitingPhase 2
Evaluation of therapeutic efficacy of Elathy chooranam(internal medicine) and Pathirasara virana poochu thailam (external medicine)in the treatment of Silai pun (varicose ulcer)
National Institute of Siddha1 site in 1 country40 target enrollmentStarted: July 27, 2017Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- National Institute of Siddha
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction of Ulcers
Study Overview
Brief Summary
This study is a single arm trial to evaluate the efficacy of Elathy chooranam and Pathirasara virana puchu thailam in the treatment of Silai pun (varicose ulcer) in adults. The trial drug Elathy chooranam with milk as adjuvant and Pathirasara virana poochu thailam as external appication is administered for 45 days. The study has got approval of Institutional Ethics Committee.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢Presence of ulcers with varicose veins •With or without Pain, Itching, Edema, Fibrinous exudates in the lesions •Hyper pigmentation •Eczema around the ulcer •Inflammation & Induration.
Exclusion Criteria
- •â€¢Diabetes Mellitus.
- •â€¢Hansen’s disease.
- •â€¢Diabetic ulcer •Gangrene •Tuberculous ulcer •Any other systemic illness.
Outcomes
Primary Outcomes
Reduction of Ulcers
Time Frame: 1-45 days
Secondary Outcomes
- •Reduction of associated symptoms of Varicosity(•The basic siddha principles will be assessed before and after the treatment.)
Investigators
Study Sites (1)
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