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临床试验/CTRI/2024/04/065495
CTRI/2024/04/065495尚未招募3 期

A comparative trial on vibhitaka and apamarga pratisarneeya teekshna kshara in abhyantara arsha (wsr third degree internal haemorrhoids)

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: 2024年4月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Changes in the symtoms of post operative pain, bleeding, size of pile mass, colour of pile mass, anal sphincter tonicity

研究概览

简要总结

The patient will be placed in a lithotomy position on the operation table and the perianal area will be cleaned with aseptic solutions. Then draping will be done with a sterilized cut sheet. After local anesthesia, lubricated Arshoyantra, pile masses will be re-assessed for their numbers, positions and sizes. One pile mass at a time will be selected. The pile mass will be scraped or rubbed and cleaned with cotton swab soaked with warm water. Then the Vibhitakaksharor ApamargaKshar will be applied over the pile mass with the help of DarvimukhaShalakaunder direct vision. As soon as applying the Kshar the opening of the Arsho Yantra will be closed by cotton swab and wait for a period of a hundred Matra Kala. When the colour of pile mass is looked like PakwaJambuPhala, the extra Ksharwill be washed out with freshly prepared NimbuSwarasa. Later the anal packing will be done with YashtimadhuTaila Pichu. All the pile masses will be applied in a single sitting.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

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 Patients of Internal Arshabetween the ages of 20 yrs to 60 yrs.
  • 2 Patients of Internal Arshawhich are Mridu, Prasrita, Avagada and Uchchhrita.
  • 3 Patients of Internal Arshahaving Pittajaand Raktajaorigin.
  • 4 Diagnosed case of Internal Haemorrhoidsof third degree.

排除标准

  • Patients of Arsha, age less than 20 yrs.
  • and more than 60 yrs.
  • • Patients with other systemic illnesses like uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis and Retrovirus positive.
  • 1.First, Second, Fourth degree Internal Piles.
  • 2.External Haemorrhoids and other associated Ano-rectal diseases.
  • • Pelvic pathology and Pregnancy.

结局指标

主要结局

Changes in the symtoms of post operative pain, bleeding, size of pile mass, colour of pile mass, anal sphincter tonicity

时间窗: on 7th day, 14th day, 21st day and 28th day

次要结局

  • Improve in quality of life(Weekly for 4 weeks)

研究者

申办方类型
Government medical college

研究点 (1)

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