Cervicitis by Iontophoresis

January 9, 2023 updated by: MARIAM HELMY, October 6 University

Effectiveness of Iontophoresis in Managing Uterine Cervicitis

The purpose of the study is to:

Investigate effect of iontophoresis on managing uterine cervicitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. All patients have vaginal discharge.
  2. All patients have irregular vaginal bleeding, especially after sexual intercourse.
  3. All patients have dyspareunia.
  4. All patients have Lower abdominal pain.
  5. Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic.
  6. Group B: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic.

Exclusion Criteria:

  1. Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone).
  2. Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels.
  3. In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation.
  4. It either should not be used or used with extreme caution during pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL ARM
Device: IONTOPHORESIS
The process of increasing the penetration of drugs into the skin by application of an electric current
Active Comparator: CONTROL ARM
Drug: ORAL ANTIBIOTIC
Oral Antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in change in Urine Analysis and Cervical swab results in both groups
Time Frame: 7 Days difference between pre and post tests
Presence of Pus Cells in Urine Analysis and a Positive Cervical swab results
7 Days difference between pre and post tests

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

December 29, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IONTOPHORESIS FOR CERVICITIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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