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The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

Primary Purpose

Atrophic Vaginitis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chinese Herbal Compound Ointment
Estriol
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Vaginitis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Sun-yat Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chinese Herbal Compound Ointment

Estriol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

symptom questionnaire scores
sign questionnaire scores

Secondary Outcome Measures

recurrence rate retreatment effect
retreatment effective rate
PH value of vaginae secretion
sIgA value of vaginae secretion
IL-1βvalue of vaginae secretion

Full Information

First Posted
March 20, 2016
Last Updated
April 8, 2016
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02733731
Brief Title
The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chinese Herbal Compound Ointment
Arm Type
Experimental
Arm Description
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.
Arm Title
Estriol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chinese Herbal Compound Ointment
Intervention Type
Drug
Intervention Name(s)
Estriol
Primary Outcome Measure Information:
Title
symptom questionnaire scores
Time Frame
77days
Title
sign questionnaire scores
Time Frame
77days
Secondary Outcome Measure Information:
Title
recurrence rate retreatment effect
Time Frame
Within 28days after treatment
Title
retreatment effective rate
Time Frame
Within 56days after treatment
Title
PH value of vaginae secretion
Time Frame
49days
Title
sIgA value of vaginae secretion
Time Frame
49days
Title
IL-1βvalue of vaginae secretion
Time Frame
49days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Zhou, master
Phone
13533259616
Email
myeva520@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bao-guo Sun, Doctor
Phone
13316134352
Email
Sunbaoguo666@126.com
Facility Information:
Facility Name
The First Affiliated Hospital of Sun-yat Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Zhou, master
Phone
13533259616
Email
myeva520@163.com
First Name & Middle Initial & Last Name & Degree
Bao-guo Sun, doctor
Phone
13316134352
Email
Sunbaoguo666@126.com

12. IPD Sharing Statement

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The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

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