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Clinical Trials/CTRI/2025/08/092452
CTRI/2025/08/092452Not yet recruitingNot Applicable

Effect of lajjalu kera in fissure-in-ano

Vyshnavi MS1 site in 1 country30 target enrollmentStarted: August 20, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Pain,

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pain,

Time Frame: assessment on 0th 8th 15th day | assessment on 30th day

Bleeding

Time Frame: assessment on 0th 8th 15th day | assessment on 30th day

Burning sensation

Time Frame: assessment on 0th 8th 15th day | assessment on 30th day

Sphincter spasm

Time Frame: assessment on 0th 8th 15th day | assessment on 30th day

length of ulcer

Time Frame: assessment on 0th 8th 15th day | assessment on 30th day

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Vyshnavi MS
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Vyshnavi M S

Government ayurveda medical college pariyaram kannur

Study Sites (1)

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