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Clinical Trials/CTRI/2024/08/072679
CTRI/2024/08/072679Not yet recruitingPhase 2/3

A Randomized Control Trial On Application of Tiladi Lepam in the Management of Parikartika (Fissure in Ano)

Dr Jaya Shankari S1 site in 1 country30 target enrollmentStarted: January 20, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Reducing pain

Study Overview

Brief Summary

Fissure in Ano is characterised by pain and burning sensation in the anal region. This condition can be correlated with Parikartika. In the present scenario, incidence of anal fissure is very high, due to unhealthy food habits. The prevalence of anal fissure is around 18% in India. In Chennai, due to intake of spicy food and mixed dietary habits, the patients with anal fissure are found to be very high. This is a very common condition in Shalya tantra OPD of SJSACH. There are various treatment modalities in modern medicine for Fissure in Ano. The need for a simple, cost effective, patient friendly method is necessary. In Ayurveda, various treatment ways are available for Parikartika (Fissure in

Ano), where 85% of results are observed in conservative management.

Tiladi lepam is a non-irritant, easily available and very convenient to use. The ingredients of Jatyadi tailam like haridra, karanja are kustaghna and krimighna and hence it can be attributed to check wound infection. The Neem and Daruharidra of Jatyadi taila are

proven drugs to check bacterial growth and promotes wound healing.

This is a Randomized Control study to evaluate the efficacy of Tiladi lepam and Jatyadi tailam in Parikartika.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Pain during defecation Passage of fresh blood or bright streaks of blood along with stool Hypertonicity assessed by digital examination.

Exclusion Criteria

  • Patients diagnosed cases of crohns disease diverticulitis ulcerative colitis Severe anal stenosis Congenital anomalies of rectum and anal canal Patients diagnosed with malignancy Immuno compromised patients suffering from HIV Syphilis TB Uncontrolled Diabetes mellitus and Hypertension Localised infection Pregnant women.

Outcomes

Primary Outcomes

Reducing pain

Time Frame: 14 days

Arrest bleeding

Time Frame: 14 days

To attain normal tonicity

Time Frame: 14 days

Secondary Outcomes

  • To improve the quality of life(15 days)

Investigators

Sponsor
Dr Jaya Shankari S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Jaya Shankari S

Sri Jayendra Saraswati Ayurveda College and Hospital

Study Sites (1)

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