The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

Atrophic Vaginitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02733731
• Other study ID #: Zxin
• Status: Recruiting
• Phase: Phase 1
• First received: March 20, 2016
• Last updated: April 8, 2016
• Start date: February 2016
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Xin Zhou, master
• Phone: 13533259616
• Email: myeva520[@]163.com
• Is FDA regulated: No
• Health authority: China:Guangdong Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Vaginitis

Intervention

Drug:
• Chinese Herbal Compound Ointment

• Estriol

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun-yat Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom questionnaire scores		77days	Yes
Primary	sign questionnaire scores		77days	Yes
Secondary	recurrence rate retreatment effect		Within 28days after treatment	Yes
Secondary	retreatment effective rate		Within 56days after treatment	Yes
Secondary	PH value of vaginae secretion		49days	Yes
Secondary	sIgA value of vaginae secretion		49days	Yes
Secondary	IL-1ßvalue of vaginae secretion		49days	Yes