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临床试验/CTRI/2025/07/091622
CTRI/2025/07/091622尚未招募不适用

Effect of topical application of triphala kumari kalka in third and fourth degree haemorrhoids

Dr Mary Grace P S1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2025年8月10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
17
试验地点
1
主要终点
Bleeding per rectum

研究概览

简要总结

This study evaluates the effect of a classical Ayurvedic formulation Triphala Kumari Kalka in managing advanced stages of Arsha like third and fourth degree hemorrhoids through topical application. Both ingredients are well documented in classical texts Charaka Samhita and Bhaishajya Ratnavali in the context of Arsha Chikitsa for their Shothahara or anti inflammatory and Ropana or wound healing properties. The study follows a non randomized, single arm, open label, pre post design in a well defined group of patients. The intervention is classical, safe and does not require surgical intervention, which makes it a promising conservative alternative. Proper ethical clearance has been obtained and patient consent will be taken in written form. Equal quantity of Haritaki, Vibheetaki and Amalaki are made in to fine powder. Mix it with equal quantity of freshly collected pulp of Aloe Vera, till it attain a paste form. Patient in lithotomy position. Clean the haemorrhoid mass and perianal region with Triphala kashaya.Prepared Lepa apply on the surface of the haemorrhoid mass in 6.5mm or ¼ angula thickness. Cover the same with sterile cotton pad. Lepa will be kept in Situ till next defecation or for 1 hour. Internally 1 tsp Triphala choornam with warm water provided as BID. Outcome measures include pain, bleeding per rectum, prolapse size, burning sensation and pruritus ani. Continue the treatment twice daily for 21 days. Assess the parameters on 0th day, 5 th day, 10th day, 15th day and 22nd day. Follow up on 45th day. During visit patient will be assessed on clinical features listed in the assessment criteria and also will be clinically examined and the same will be documented.

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

  • Clinically diagnosed cases of 3rd and 4th degree Haemorrhoids.
  • Bleeding and non-bleeding Haemorrhoids.
  • Participants who give written informed consent.

排除标准

  • 1.Haemorrhoids associated with known case of malignancy.
  • Prolapsed rectum.
  • Diagnosed case of HIV/AIDS, HBsAg and other STD 4.

结局指标

主要结局

Bleeding per rectum

时间窗: on 5th 10th 15th 22nd days

Burning Sensation

时间窗: on 5th 10th 15th 22nd days

Pruritus ani

时间窗: on 5th 10th 15th 22nd days

Size of Prolapsed Pile mass

时间窗: on 5th 10th 15th 22nd days

Pain

时间窗: on 5th 10th 15th 22nd days

次要结局

未报告次要终点

研究者

发起方
Dr Mary Grace P S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mary Grace P S

Government Ayurveda College Kannur

研究点 (1)

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