Clinical Trial: The Treatment Effect of Chinese Herbal Compound Ointment on Atrophic Vaginitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary: 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.
Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Current Primary Outcome:

  • symptom questionnaire scores [ Time Frame: 77days ]
  • sign questionnaire scores [ Time Frame: 77days ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital, Sun Yat-Sen University

Dates:
Date Received: March 20, 2016
Date Started: February 2016
Date Completion: June 2016
Last Updated: April 8, 2016
Last Verified: March 2016