跳至主要内容
临床试验/CTRI/2025/02/080012
CTRI/2025/02/080012尚未招募不适用

A Randomized controlled clinical study to evaluate the efficacy of vrisha ksharasutra with apamarga ksharasutra in the patients of bhagandara(fistula-in-ano).

S.V.Ayurvedic College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Accessing unit

研究概览

简要总结

The Bhagandara has been explained in all Brihatrayee and laghutrayee’s. But specially Acharya Sushruta has given a very detailed description about the etiopathogenesis, classification (S.S.Ni.4) complication, management and other aspects of Bhagandara.

AcharyaSushruta has described surgical approach like excision of fistulous track in detail (S.S.Su 25/3, S.S. Ci 8/6) but also felt the necessity of para-surgical approach like Kshara Sutra (S.S.Ci 17/32, C.S.Ci 12/97. Chakradatta –Arshavyadhi adhikara). Since he was not satisfied with only surgical excision in specific patients who are emaciated, weak and frightful, he then advised Kshara Sutra. He also explained method of preparation of kshara sutra.

In the present research is to study the efficacy of Vrisha Kshara Sutra is the best treatment opinion for the management of Bhagandara is taken from reference of Sushruta Samhita (Su.Su.). Hence the process of Vrisha Kshara preparation is done as mentioned in the Sushruta Samhita sutra sthana 11th chapter.The ingredients of Vrisha ksharasutra consists of Vrisha kshara, snuhi kshira, haridra churnam. Acharya Sushruta in sutrasthana Ksharapaka vidhi adhayaya  has mentioned 21drugs can be used for the preparation of Kshara among which Vrisha is selected in the preparation of Kshara Sutra as the kshara has properties, Chedana, Bhedana, Lekhana, anti-bacterial, anti-microbial, anti-inflammatory, anti-spasmodic, anti hemorrhagic, anti-helminthic.

Lacunas, If any:

Kshara sutra is well known treatment procedure accepted and also in practice since ages. But the standard Apamarga Kshara Sutra is causing pain during its stay in tract and its availability in particular season. To overcome this situation, the present study is selected.

Need for the study:

To lead the patient to get relief from this painful condition and to improve the quality of life by adopting a para surgical procedure which is free from surgical complications and recurrences.

Scope of the study:

. Plant is ready for use in all seasons ,easy for the preparation of Ksharasutra in batches instantly when required.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)

入选标准

  • 1.Patients irrespective of Gender and religion from the age group of 20 to 60 years.
  • Patients Patients with signs and symptoms of Bhagandhara.
  • Patients who are diagnosed as Fistula-in-ano.

排除标准

  • Concomitant Ano-rectal conditions like ulcerative colitis, malignancy, Crohn’s disease, multiple fistulae.
  • Tuberculosis.
  • Obstructive Uropathies.
  • 5.Systemic diseases like CAD, Portal hypertension.
  • 6.Patients with uncontrolled blood sugars.

结局指标

主要结局

Accessing unit

时间窗: Accessing the pain, discharge, itching, unit | cutting time and tenderness for every one week until | cut open of a track. The efficacy is calculated by | comparing the both subjecive and objective | parameters of both ksharasutras each other.

cutting time and tenderness for every week until

时间窗: Accessing the pain, discharge, itching, unit | cutting time and tenderness for every one week until | cut open of a track. The efficacy is calculated by | comparing the both subjecive and objective | parameters of both ksharasutras each other.

cut open of a track. The efficacy is calculated by

时间窗: Accessing the pain, discharge, itching, unit | cutting time and tenderness for every one week until | cut open of a track. The efficacy is calculated by | comparing the both subjecive and objective | parameters of both ksharasutras each other.

comparing the both subjecive and objective

时间窗: Accessing the pain, discharge, itching, unit | cutting time and tenderness for every one week until | cut open of a track. The efficacy is calculated by | comparing the both subjecive and objective | parameters of both ksharasutras each other.

parameters of both ksharasutras each other.

时间窗: Accessing the pain, discharge, itching, unit | cutting time and tenderness for every one week until | cut open of a track. The efficacy is calculated by | comparing the both subjecive and objective | parameters of both ksharasutras each other.

次要结局

  • Complete healing time, reoccurrences & any(other complications like incontinency, discharge,)

研究者

发起方
S.V.Ayurvedic College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DrAnakarla Harish Kumar

S.V. Ayurvedic College and Hospital

研究点 (1)

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