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临床试验/CTRI/2024/08/073025
CTRI/2024/08/073025尚未招募3 期

AN OPEN LABELLED CLINICAL STUDY TO EVALUATE THE EFFECT OF ERANDA KARKATI KSHEERA PAPAYA LATEX BASED CHITRAKA KSHARASUTRA IN THE MANAGEMENT OF BHAGANDARA W.S.R TO FISTULA IN ANO

SDM College of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月7日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To find out Unit Cutting time of Chitraka Ksharasutra by changing the ksharasutra every weekly until the tract gets completely cut through and until wound heals

研究概览

简要总结

The Indian Council of Medical Research (ICMR) conducted randomized multi-centric clinical trials on

Ksharasuthra therapy and found that, the recurrence of anal fistula was only 4% as compared to 11% in patients

who had undergone conventional surgery [7]

According to Classics, Snuhi Ksheera is used in the preparation of Ksharasutra. But Snuhi is not available

throughout the year, the time for collection is in Adana Kala particularly in Shishira Ritu, Snuhi coagulates

within few minutes of collection, hence in order to overcome these lacuna Eranda Karkati Ksheera (Papaya

latex) is used, as it easily available, has binding properties and can be preserved for long duration [8]

.

After the establishment of Ksharasutra as an effective treatment methodology, it has been a constant

endeavour of Ayurvedic surgeons to bring in innovative and effective changes in the preparation of

Ksharasutra. This work of preparation of Eranda Karkati Ksheera (Papaya latex) based Chitraka Ksharasutra

is also a step in the same direction

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with clinical signs and symptoms of Bhagandara or Fistula in ano as explained in Ayurvedic and modern text books.

排除标准

  • Patients suffering from systemic diseases like uncontrolled diabetes, Chronic Renal, Hepatic, Cardiac disorders Patients suffering from secondary fistula due to carcinoma, ulcerative colitis, Tuberculosis Patients suffering from infectious disease like H.I.V, Hepatitis-B.
  • High anal fistula.

结局指标

主要结局

To find out Unit Cutting time of Chitraka Ksharasutra by changing the ksharasutra every weekly until the tract gets completely cut through and until wound heals

时间窗: St Mark Anal incontinence score | Discharge in Perianal region | Itching in Perianal region

次要结局

  • Observing UCT of fistulous track,(Anal incontinence)

研究者

发起方
SDM College of Ayurveda
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Adarsh Shahapurkar

SDM College of Ayurveda Kuthpady Udupi

研究点 (1)

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