The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

April 8, 2016 updated by: Zhou Xin, First Affiliated Hospital, Sun Yat-Sen University

Objective：To evaluate the effect and safety of the traditional chinese medicine oil agent on senile atrophic compared as compared to estriol cream in aged woman.

Design: A randomized double-blind controlled trial.

Setting: The hospital ward.

Participants: 200 postmenopausal woman with senile vaginitis (mean age 56).

Intervention: The traditional chinese medicine oil and estriol cream were separately intravaginal administrated in treatment group and control group for 3 weeks，follow-up 1 month.

Measurement: symptom improving(pain and itch) and onset time, edema-size of vaginal wall, vaginal discharge, and PH changes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

80 postmenopausal women living in the communities near the hospital with AV (atrophic vaginitis) symptoms were recruited for this clinical trial. Patients with AV receiving external treatment and requiring hospitalization were randomized in a double-blind, single-centre trial. Subjects received CHCO (Chinese Herbal Compound Ointment) topical vaginal application in experimental group, while estriol in control group. The dosage of medicine for single treatment once a day in two group is 0.5g.The total time for therapy is 3 weeks in two groups. Assessment indicators：vagine PH, sIgA and IL-1βchanges, the degree of symptoms improving, onset time, edema-size of vaginal wall, vaginal discharge, and relapses and retreatment effect.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • 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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Sun-Yat Sen University
        • Contact:
        • 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

46 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal women
  • With typical clinical manifestations: virginal genital itching or burning sense, Increased vaginal secretions, a yellow, a serious bloody pus-like leucorrhea, or sexual intercourse pain
  • Gynecological examination: Vaginal epithelium atrophy，Vaginal folds flat or disappear， mucosal hyperemia， superficial ulceration
  • Both ALT and AST are normal or less than 2 times, bilirubin is normal
  • Serum creatinine level is within the normal range
  • ECG is normal;

Exclusion Criteria:

  • Gynecological and breast Oncology, endometrial hyperplasia(≥5mm)
  • Estrogenic drugs or probiotics used in four week
  • Participate in other clinical trials;Thrombotic diseases
  • Abnormal vaginal bleeding without clear diagnose
  • Estriol allergy
  • Severe pneumonia, tuberculosis, lung abscess, myocarditis
  • heart,liver or kidney failure(NYHA class III-IV,ALT to AST ratio twice more than upper limit of normal
  • sexually transmitted diseases;mental disorders

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chinese Herbal Compound Ointment
This kind of CHCO composed of several chinese herbs,dong quai,angelica,resina draconis and lithospermum.The dosage of medicine for single treatment once a day in two group is 0.5g,The total time for therapy is 3 weeks.
Drug: Chinese Herbal Compound Ointment
Active Comparator: Estriol
The dosage of medicine for single treatment once a day in two group is 0.5g,The total time for therapy is 3 weeks in two groups.
Drug: Estriol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
symptom questionnaire scores
Time Frame: 77days
77days
sign questionnaire scores
Time Frame: 77days
77days

Secondary Outcome Measures

Outcome Measure
Time Frame
recurrence rate retreatment effect
Time Frame: Within 28days after treatment
Within 28days after treatment
retreatment effective rate
Time Frame: Within 56days after treatment
Within 56days after treatment
PH value of vaginae secretion
Time Frame: 49days
49days
sIgA value of vaginae secretion
Time Frame: 49days
49days
IL-1βvalue of vaginae secretion
Time Frame: 49days
49days

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital, Sun Yat-Sen 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

February 1, 2016

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

March 20, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Estimate)

April 11, 2016

Last Update Submitted That Met QC Criteria

April 8, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zxin

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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