跳至主要内容
临床试验/CTRI/2024/06/068947
CTRI/2024/06/068947尚未招募Phase 3 4

Clinical comparative study to evaluate the efficacy of IFTAK procedure and application of trivratyadi taila after IFTAK procedure in the management of bhagandar(fistula in ano)

Post Graduate Institute Of Ayurved Jodhpur Rajasthan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月30日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To assess the clinical efficacy of application of Trivratyadi Taila after IFTAK procedure compared to only IFTAK procedure in the management of Bhagandar fistula in ano

研究概览

简要总结

Study Type                                             :      Interventional , comparative clinical study

Sample size                                           :      40(20 patients in each group)

40 patients fulfilling the inclusion criteria are fit for the study, should be randomly selected:

Group A- IFTAK procedure is done by interception of fistulous tract by creating a window opening at 6 o’clock position and application of ksharsutra through window.

Group B- IFTAK procedure is done same as group A with application of  Trivratyadi Taila  5 ml for Taila Pooran in Fistulous tractslowly under all aseptic precaution.

Duration of study                             :      2 Months

Follow up â€“ weekly after finishing the trial treatment protocol period

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Blind fistula in ano.
  • Low anal fistula in ano.
  • All type tract of Crypto glandular fistula in ano
  • Recurrent fistula in ano.
  • Complex fistula in ano.

排除标准

  • Bhagandara present with tuberculosis.
  • Regional Ileitis
  • Any malignancies related with fistula in ano.
  • Chronic/acute ulcerative Colitis.
  • HIV& HbsAg Positive patient.
  • Crohn’s disease
  • Fecal Fistula & Uretero-Vaginal Fistula
  • Non-Crypto glandular Fistula in ano.

结局指标

主要结局

To assess the clinical efficacy of application of Trivratyadi Taila after IFTAK procedure compared to only IFTAK procedure in the management of Bhagandar fistula in ano

时间窗: 60 days

次要结局

  • To understand the IFTAK procedure & to rule out the efficacy of application of Trivratyadi Taila after IFTAK in management of Bhagandar(60 days)

研究者

发起方
Post Graduate Institute Of Ayurved Jodhpur Rajasthan
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Maninder Singh Sisodiya

Post Graduate Institute Of Ayurved Jodhpur Rajasthan

研究点 (1)

Loading locations...

相似试验