Preclinical and Clinical Study to Evaluate the Vranaropana Karma (Wound Healing Activity) of Sarala (Pinus roxburghii Sargent) Exudate
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- The safety and clinical efficacy of the test drug by monitoring the wound area, wound appearance, TC, DC, ESR, Hb%
Overview
Brief Summary
This clinical study, which will take place at the OPD of the IPGAER at SVSP Hospital, is a randomized, parallel-grouped control trial of a test drug comparing the safety and efficacy of Mupirocin for 28days in 20 patients suffering from different type of wounds. The primary outcome of this research is to evaluate the therapeutic efficacy of the test drug for its potential wound healing activity. The secondary outcome is to determine the safety of the test drug on quality of life among the patients suffering from different dermal injury.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •The clinical study will be single blind clinical study, with two groups of patients (male and female both) suffering from acute wound, partial fistulectomy wound in the OPD and IPD of the hospital at IPGAER, Kolkata.
Exclusion Criteria
- •Age below 20years or above 60years
- •Pre-existing diabetes mallitus
- •History of severe trauma
- •Pregnancy and lactating mother
- •Excessive P/R bleeding
- •Sexually transmitted disease
- •Malignancy
- •Patient with H/O multiple surgical intervention.
Outcomes
Primary Outcomes
The safety and clinical efficacy of the test drug by monitoring the wound area, wound appearance, TC, DC, ESR, Hb%
Time Frame: 28 days
Secondary Outcomes
- Safe, Effective, Economical wound healing ayurvedic drug for the suffering patients(28 days)
Investigators
Dr Amit Kumar Taraphdar
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital