“A Clinical Evaluation Of Ksharasutra Prepared By Using Sushrutokt Kshara In Comparision Of Apamarga Ksharasutra In The Management Of Bhagandara (Fistula-In-Ano)â€
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Pain 2.Tenderness 3.Tenderness
研究概览
简要总结
A computer generated randomized clinical trial Entitled with**“A Clinical Evaluation OfKsharasutra PreparedByUsingSushrutokt Kshara In Comparision Of Apamarga Ksharasutra In The Management Of Bhagandara (Fistula-In-Ano)*â€**contains 2 groups with 50 patients in each group. Group A patients will be treated with Ksharsutra prepared by using Sushrutokt Kshara and group B by standard Apamarga Ksharsutra.*Ksharasutra changesafter every 7 days till complete healing of fistulous tract (approx.3 months ) as per registered Groups.All the patients registered for the study will be followed up on the weekly basis till complete healing of fistulous tract(approx.3 months ),then patients will be followed up every month for further six months.Criteria of assessment parameters are Pain(VAS Grading) Tenderness Burning sensation Itching Pus Discharge Unit HealingTime (UHT) All Parameters Assessment will be done in every 7 days till complete healing of fistulous tract (Approx. 3 month).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of Bhagandara from
- •60 Years age group, irrespective of sex and economic status. 2.No major systemic disease involved. 3.Patients who have signs and symptoms of Bhagandara (Fistula-in-ano) like pidika, ruja, srava, kandu etc. 4.Patients who is agreed to sign the consent form.
排除标准
- •1.Patients belongs to less than 20 years and greater than 60 years of Age group.
- •2.Patient with known hypersensitivity to any of the components of the formulation.
- •3.High level fistula having internal opening in rectum or above anorectal ring.
- •4.Bhagandara (Fistula-in-ano) associated with one or more of the following conditions:- a.
- •Supra levator fistula in ano b.
- •Ulcerative Colitis c.
- •Uncontrolled Hypertension d.
- •Uncontrolled Diabetes Mellitus e.
- •Venereal diseases f.
- •HIV and Hepatitis B& C Patients.
- •g.CA rectum h.
- •Crohn’s disease i.Fistula other than ano-rectal area.
- •j.All other secondary Fistula-in-ano.
结局指标
主要结局
1.Pain 2.Tenderness 3.Tenderness
时间窗: All Parameters Assessment will be done in every 7 days till complete healing of fistulous tract (Approx. 3 month).
4.Itching
时间窗: All Parameters Assessment will be done in every 7 days till complete healing of fistulous tract (Approx. 3 month).
次要结局
- 5.Pus discharge 6. Unit healing time (U.H.T.)(All Parameters Assessment will be done in every 7 days till complete healing of fistulous tract (Approx. 3 month).)