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临床试验/CTRI/2019/06/019828
CTRI/2019/06/019828已完成4 期

A CLINICAL EVALUATION OF VASA KSHARASUTRA IN THE MANAGEMENT OF BHAGANDARA (FISTULA-IN-ANO)

NAtional Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月7日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Reduction in the Unit Cutting Time (UCT) of the Fistulous Tract

研究概览

简要总结

Objectives

a.       To evaluate the efficacy of Vasa Ká¹£arasutra in the management of  Bhagandara(Fistula-in-Ano).

 b.      To compare the efficacy of Vasa Ká¹£arasutra with conventional Apamarga Ká¹£arasutra in the management of Bhagandara(Fistula-in-Ano).

Results and conclusions

v Bhagandara(Fistula-in-ano) is a disease which was mentioned since the time of Vedas and Purana.

vKsharasutra treatment is the most suitable and effective modality in the treatment of Bhagandara.

v Ksharasutra method can be known as a treatment which is safe, effective with minimum or no recurrence.

v The people suffering from constipation, Mandagni, having irregular dietary habits, are prone to this disease and the incidence of Bhagandara (Fistula-in-ano) is more in males as compared to females.

v The prevalence of Bhagandara is more in the middle age group with who does not have proper hygiene.

v Both types of Ksharasutras are cost effective and easily applicable.

v Both types were found to be very much effective in reduction of discharge, pain, itching, burning sensation, tenderness and oedema. Inter group compression showed there was no difference between the groups.

v Vasa Ksharasutra is having significant less UCT when compared with the Apamarga Ksharasutra.

v Both the variety shows less recurrences.

v Necrosis, anal incontinence and stenosis were not reported in either group.

v Finally we can conclude Vasa Ksharasutra is an alternative for Apamarga Ksharasutra and by comparing UCT can decide it’s having much better action than Apamarga Ksharasutra.

研究设计

研究类型
Observational

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.Male or female between age 20 to 60 years and willing to give their written Informed consent.
  • 2.No major systemic disease involved.
  • Patients who have signs and symptoms of Bhagandara (Fistula-in-ano).

排除标准

  • Bhagandara (Fistula-in-ano) associated with one or more of the following conditions:- Ulcerative Colitis Uncontrolled Hypertension Uncontrolled Diabetes Mellitus Veneral diseases HIV and Hepatitis B patients Crohn’s disease Fistula other than ano-rectal area.
  • All other secondary Fistulae-in-ano.

结局指标

主要结局

Reduction in the Unit Cutting Time (UCT) of the Fistulous Tract

时间窗: 90 days

次要结局

  • Reduction in pain, itching and amount of discharge of the Fistulous Tract.(90 Days)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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