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Clinical Trials/CTRI/2021/03/032042
CTRI/2021/03/032042Not yet recruitingNot Applicable

Clinical and scientific evaluation of Gudabhransa (Prolaps of Rectum) and its management

DrNagesh Kumar Yadav1 site in 1 country30 target enrollmentStarted: December 4, 2021Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Wexner Incontinence score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is a randomized trial done in India for Clinical and scientific evaluation of Gudabhransa (Prolapse of Rectum) and its management through Ayurvedic oral drug therapy, Basti therapy and surgical procedure, modified thiersch EACKS method. The primary outcome measures the Wexner incontinence score at 3 months.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
10.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Partial prolapse of rectum Mucosal Prolapse patients not willing for major surgery.

Exclusion Criteria

  • •Prolapse haemorrhoids Carcinoma of rectum Complete rectal prolapse Cystocoel Rectocoel Colitis Uncontrolled diabetic mellitus Immuno-compromised patients Sentinel Tag Haemorrhoid HIV/HBsAg positive subjects Patient with any systemic infection.

Outcomes

Primary Outcomes

Wexner Incontinence score

Time Frame: 3 months

Secondary Outcomes

  • ANAL TONE BY PER RECTAL DIGITAL EXAMINATION(1 month)
  • ANAL TONE BY anal manometry(1 month)

Investigators

Sponsor
DrNagesh Kumar Yadav
Sponsor Class
Other [Phd Student]

Study Sites (1)

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