AN OPEN LABEL RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF NAGAVALLI VARTH WITH DICLOFENAC SUPPOSITORY IN THE MANAGEMENT OF CHRONIC FISSURE-IN-ANO
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Nagavalli Varthi will result in significant pain reduction and healing of chronic fissure-in-ano compared to Diclofenac suppository.
Study Overview
Brief Summary
THIS STUDY HAS BEEN TAKEN UP TO EVALUATE THE EFFICACY OF NAGAVALLI VARTHI WITH DICLOFENAC SUPPOSITORY IN THE MANAGEMENT OF CHRONIC FISSURE-IN ANO
H0 - There is no significant difference between the efficacy of Nagavalli Varthi and Diclofenac suppository in the management of Chronic fissure-in-ano.
H1 - There is significant difference between the efficacy of Nagavalli Varthi and Diclofenac suppository in the management of Chronic fissure-in-ano.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 21.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed case of chronic fissure-in-ano duration greater than six weeks Parikarthika, sadaha, parikartana, anilasanga Age group: 21 to 70 years, both genders willing to participate Complaints of pain during defecation, bleeding per rectum, burning sensation, post-defecation Single posterior anterior fissure on clinical examination.
- •Willing to give written informed consent.
- •Willing to comply with the treatment protocol and follow-up visits.
Exclusion Criteria
- •Acute fissure-in-ano duration less than 6 weeks.
- •Pregnant women Known allergy or hypersensitivity to any components of diclofenac Psychiatric illness or cognitive impairment Patients suffering from systemic diseases like hepatitis, tuberculosis, HIV Patient with associated anorectal disease like fistula in ano, hemorrhoids, polyp, abscess and malignancy.
Outcomes
Primary Outcomes
Nagavalli Varthi will result in significant pain reduction and healing of chronic fissure-in-ano compared to Diclofenac suppository.
Time Frame: 14 days
Severe pain to moderate pain
Time Frame: 14 days
From moderate to mild pain
Time Frame: 14 days
Significant healing of ulcer
Time Frame: 14 days
Secondary Outcomes
- Improvement in physical and psychological health
Investigators
Dr Nadhi Suresh
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH