A randomised controlled clinical trial to evaluate the efficacy of Rasanjanadi Lepa in mangament Of Nadi Vrana (Pilonidal Sinus)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Dr Sarvagya Pathak
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Wound dimension
Overview
Brief Summary
This study is Randomised ,Parallel group, active controlled trial to evaluate the safety and efficacy of Rasanjanadi lepa, in 172 patient aged between 16 to 45 years , over a period of 18 months. The patient will be of 21 days . During the trial assessment will be done on 0th , 7th, 14th, 21th, 28th days . After trial , follow up will be done after 43rd , 58th, 73rd, & 88th day after cessation of procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 16.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age group of patient 16 to 45 years.
- •Patient diagnosed with Pilonidal Sinus & Abscess as per diagnostic criteria .
- •Patient capable of reading , completing, and assigning the consent from participating in the study.
Exclusion Criteria
- •Presenting with dry & hard ulcer Presenting with Vatadhik Lakshan pregnant and lactating women Addiction to drugs and alcohol Abnormal bleeding from the wound using drugs that affect wound healing such as corticosteroids Using antibiotics prior to surgical intervention Not continuing the proposed treatment until the end of the study or request to leave the study History of severe allergy or anaphylactic shock caused by similar treatment Patient who has undergone organ transpiration Known case of connective tissue disease Known allergies to herbal drugs.
Outcomes
Primary Outcomes
Wound dimension
Time Frame: 21 days
Depth of wound
Time Frame: 21 days
Wound excaudate quantity
Time Frame: 21 days
Improvement in other symptoms or Pilonidal Sinus
Time Frame: 21 days
Bacterial load by culture & sensitivity test
Time Frame: 21 days
CRP
Time Frame: 21 days
Time period
Time Frame: 21 days
Wound volumetry
Time Frame: 21 days
Secondary Outcomes
- Improvement in other symptoms like pain(After analysing all the parameters the result will be assessed on the basis of symptomatic relief and improvement.)
Investigators
Dr Sarvagya Pathak
Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre , Gangoh-247341.