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临床试验/CTRI/2025/08/092452
CTRI/2025/08/092452尚未招募不适用

Effect of lajjalu kera in fissure-in-ano

Vyshnavi MS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月20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
30
试验地点
1
主要终点
Pain,

研究概览

简要总结

Fissure-in-ano is a painful anorectal condition commonly causing bleeding per rectum and affecting a large portion of the population. It can be acute, with recent tears and sphincter spasm, or chronic, with inflamed and scarred margins. While acute cases may heal with conservative measures like sitz baths and topical agents, chronic fissures often require surgical treatment, which may lead to complications such as bleeding or incontinence. In Ayurveda, the condition is correlated with Parikartika, described with symptoms like cutting pain, burning sensation, and difficulty in defecation. Classical treatments include Pichabasti, Anuvasana Basti, and application of medicated oils to pacify Vata and Pitta. This study evaluates the effect of Lajjalu Kera Taila—a formulation using Lajjalu (Mimosa pudica), known for its wound-healing and hemostatic properties, and Kera Taila (coconut oil), which is anti-inflammatory and lubricating. anal instillation of lajjalu kera done  for 14 days in 30 patients aged 18–65 years with fissure-in-ano at Government Ayurveda College, Pariyaram. The results showed significant reduction in symptoms, suggesting that this Ayurvedic approach is a safe, effective, and economical alternative to conventional surgical management.

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 65.00 Year(s)(—)
性别
All

入选标准

  • The diagnosis will be confirmed by a Linear ulcer at the long axis of anal canal either at the posterior or anterior midline along with any of the two mentioned below Pain during and after defecation in the anal region Burning sensation after defecation Blood streaks on the stool Age group between 18 to 65 years.

排除标准

  • Participants with known case of Ca rectum Ca anus Participants with fistula in ano Known case of fissure secondary to tuberculosis Inflammatory bowel disease syphilis and other systemic disease pertaining to Colo-rectum will be excluded from the study Patients with diseases like HIV & Hepatitis B Bleeding disorders Patients with uncontrolled DM.

结局指标

主要结局

Pain,

时间窗: assessment on 0th 8th 15th day | assessment on 30th day

Bleeding

时间窗: assessment on 0th 8th 15th day | assessment on 30th day

Burning sensation

时间窗: assessment on 0th 8th 15th day | assessment on 30th day

Sphincter spasm

时间窗: assessment on 0th 8th 15th day | assessment on 30th day

length of ulcer

时间窗: assessment on 0th 8th 15th day | assessment on 30th day

次要结局

未报告次要终点

研究者

发起方
Vyshnavi MS
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vyshnavi M S

Government ayurveda medical college pariyaram kannur

研究点 (1)

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