AN OPEN LABEL RANDOMIZED CLINICAL STUDY TO COMPARE THE EFFICACY OF NAGAVALLI VARTH WITH DICLOFENAC SUPPOSITORY IN THE MANAGEMENT OF CHRONIC FISSURE-IN-ANO
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nagavalli Varthi will result in significant pain reduction and healing of chronic fissure-in-ano compared to Diclofenac suppository.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Nagavalli Varthi will result in significant pain reduction and healing of chronic fissure-in-ano compared to Diclofenac suppository.
时间窗: 14 days
Severe pain to moderate pain
时间窗: 14 days
From moderate to mild pain
时间窗: 14 days
Significant healing of ulcer
时间窗: 14 days
次要结局
- Improvement in physical and psychological health
研究者
Dr Nadhi Suresh
SRI SRI COLLEGE OF AYURVEDIC SCIENCE HOSPITAL AND RESEARCH