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临床试验/CTRI/2024/10/074800
CTRI/2024/10/074800尚未招募2 期

Comparative clinical evaluation of Snuhi-Apamarga kshar sutra and Guggulu -Nimba kshar sutra in Bhagandara(Fistula-in-ANO)

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Subjective Parameters–

研究概览

简要总结

In this trial we are selecting patients of Bhagandara (Fistula-in-Ano) and dividing them into two groups with 30 patients in each group. In 1st group, we will do intervention with standard Snuhi-Apamarga kshar sutra ligation of fistula tract and in 2nd group, we will do intervention with Guggulu- Nimba kshar sutra ligation of fistula tract. Comparative study to be done on the basis of assessment based on subjective and objective parameters. Subjective parameters includes Burning sensation , Itching, Discharge, Pain and Inflammation and Objective parameters includes unit cutting time

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient age ranging between
  • 60 years Clinical Signs and Symptoms of all types of Bhagandara. Patient diagnosed as well as recurrent cases of Fistula in -Ano.

排除标准

  • • HBsAg, HCV and HIV positive patients. • Secondary fistulas due to:.
  • Crohn’s disease
  • Ulcerative colitis
  • Carcinoma of Rectum
  • Pelvic Abcess
  • Tuberculosis
  • Osteomyelitis of Pelvic Bone.
  • Patient having uncontrolled Diabetes and Hypertension.
  • Other systemic disorder.

结局指标

主要结局

Subjective Parameters–

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

Itching

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

Burning sensation

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

Discharge

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

Pain

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

Inflammation

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

Objective parameters-

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

unit cutting time

时间窗: Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed

次要结局

  • Subjective Parameters-(Itching)

研究者

发起方
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anuj

Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan

研究点 (1)

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