Randomized controlled clinical trial to evaluate the efficacy of Nimba Kshara Pratisaran in the management of Post Operative Partial Fistulectomy Hypergranulated Wound
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- To reduce signs and symptoms of hypergranulation i.e. Pain, Itching, Size of Wound, Margin, Height of granulation tissue till 28 days
Study Overview
Brief Summary
Hypergranulation is excessive granulation that rises above the wound surface. In post operative partial fistulectomy procedure, Hypergranulation is seen near the external opening of fistula.
Pratisarneeya kshara is used in the wound with symptoms like indurations, itching, and have raised hypertrophied granulation tissue.
Nimba kshara pratisaran is having Tridosh nashana, chedana, bhedana, lekhana and ropana properties which is useful for wound healing.
A Study will be conducted on 92 diagnosed patients having classical signs and symptoms of Hypergranulation in post operative partial fistulectomy wound.
Written informed consent will be taken.
Inital assessment on 1st day, then randomization will be done.
Group allocation with Group A and
Follow up on 7th, 14th, 21st, 28th day.
Observations and result will be noted.
Statistical analysis
Discussion and conclusion
Summary.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 16.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Clinically diagnosed Patients having classical signs of hypergranulation in post operative partial fistulectomy wound , selection will be irrespective of sex, religion, and socioeconomic status, Age between 16-70 years.
- •Wound size upto length of 4cm into 1 cm.
Exclusion Criteria
- •Patients with malignant ulcers.
- •Patients below age 16 and above 70 years.
- •Gangrenous wond.
- •Bleeding disorders.
- •Patients suffering from DM, HTN.
Outcomes
Primary Outcomes
To reduce signs and symptoms of hypergranulation i.e. Pain, Itching, Size of Wound, Margin, Height of granulation tissue till 28 days
Time Frame: Baseline, 7th day, 14th day, 21st day, 28th day
Secondary Outcomes
- To reduce the size of wound.(Baseline, 7th day, 14th day, 21st day, 28th day)
Investigators
Dr Snehal Shivaji Kayande
CSMSS Ayurved Mahavidyalaya and Rugnalaya