NCT02733731

The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrophic Vaginitis

Interventions

Type	Name	Description
DRUG	Chinese Herbal Compound Ointment
DRUG	Estriol

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2016-04-11
• Last updated: 2016-04-11

Locations

1 site across 1 country: China