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Cervicitis by Iontophoresis

Primary Purpose

CERVICITIS

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
IONTOPHORESIS
ORAL ANTIBIOTIC
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CERVICITIS

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: All patients have vaginal discharge. All patients have irregular vaginal bleeding, especially after sexual intercourse. All patients have dyspareunia. All patients have Lower abdominal pain. Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic. Group B: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic. Exclusion Criteria: Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone). Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels. In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation. It either should not be used or used with extreme caution during pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    EXPERIMENTAL ARM

    CONTROL ARM

    Arm Description

    Outcomes

    Primary Outcome Measures

    Difference in change in Urine Analysis and Cervical swab results in both groups
    Presence of Pus Cells in Urine Analysis and a Positive Cervical swab results

    Secondary Outcome Measures

    Full Information

    First Posted
    December 29, 2022
    Last Updated
    January 9, 2023
    Sponsor
    October 6 University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05675293
    Brief Title
    Cervicitis by Iontophoresis
    Official Title
    Effectiveness of Iontophoresis in Managing Uterine Cervicitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 15, 2023 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    October 6 University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to: Investigate effect of iontophoresis on managing uterine cervicitis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    CERVICITIS

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EXPERIMENTAL ARM
    Arm Type
    Experimental
    Arm Title
    CONTROL ARM
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    IONTOPHORESIS
    Intervention Description
    The process of increasing the penetration of drugs into the skin by application of an electric current
    Intervention Type
    Drug
    Intervention Name(s)
    ORAL ANTIBIOTIC
    Intervention Description
    Oral Antibiotic
    Primary Outcome Measure Information:
    Title
    Difference in change in Urine Analysis and Cervical swab results in both groups
    Description
    Presence of Pus Cells in Urine Analysis and a Positive Cervical swab results
    Time Frame
    7 Days difference between pre and post tests

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients have vaginal discharge. All patients have irregular vaginal bleeding, especially after sexual intercourse. All patients have dyspareunia. All patients have Lower abdominal pain. Group A: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic. Group B: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic. Exclusion Criteria: Patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone). Patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels. In the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation. It either should not be used or used with extreme caution during pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MARIAM HELMY, DEMONSTRATOR
    Phone
    01129985772
    Email
    MARIAMHELMYMHR@GMAIL.COM

    12. IPD Sharing Statement

    Learn more about this trial

    Cervicitis by Iontophoresis

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