Ignite Creation Date:
2024-05-06 @ 8:25 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02733731
Status:
UNKNOWN
Last Update Posted:
2016-04-11
First Post:
2016-03-20
Brief Title:
The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis
Sponsor:
First Affiliated Hospital Sun Yat-Sen University
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ObjectiveTo 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 weeksfollow-up 1 month
Measurement symptom improvingpain and itch and onset time edema-size of vaginal wall vaginal discharge and PH changes
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 weeksfollow-up 1 month
Measurement symptom improvingpain 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 05gThe total time for therapy is 3 weeks in two groups Assessment indicatorsvagine 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None