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Clinical Trials/CTRI/2018/03/012668
CTRI/2018/03/012668CompletedPhase 3

Efficacy of a Unani formulation as topical application in Quruhal Rahim - An open labelled observational study

National institute of unani medicine1 site in 1 country30 target enrollmentStarted: January 25, 2017Last updated:

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Cervical erosion grading scale with three grades

Study Overview

Brief Summary

Cervical erosion is one of the commonest clinical entities seen in reproductive age group. An open observational study was carried out on 30 patients with vaginal discharge, low backache and cervical erosion on examination. Drugs Commiphora myrrha, lead carbonate, Astragalus sarcocola, bees wax and rose oil   were  given in the form of ointment for 14 days. The improvement in cervical erosion  was credited to the anti inflammatory, anti oxidant, cytotoxic, anti microbial, sedative, hemostatic  properties of research drug .

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Participant Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Married women in the age group 20- 40 yrs Patients with cervical erosion on per speculum examination Patients with vaginal discharge Patients with normal or inflammatory changes in pap smear.

Exclusion Criteria

  • Patients with premalignant or malignant changes in pap smear Frank growth on the cervix Pelvic inflammatory disease OC Pills and IUCD’s Systemic illnesses (UTI, TB, DM) & STD’s (Syphilis, HIV) Pregnant & lactating women.

Outcomes

Primary Outcomes

Cervical erosion grading scale with three grades

Time Frame: Two weeks

Secondary Outcomes

  • relief in vaginal discharge(and low back ache)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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