NCT02733731

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 11, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 11, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

March 20, 2016

Last Update Submit

April 8, 2016

Conditions

Atrophic Vaginitis

Outcome Measures

Primary Outcomes (2)

  • symptom questionnaire scores

    77days

  • sign questionnaire scores

    77days

Secondary Outcomes (5)

  • recurrence rate retreatment effect

    Within 28days after treatment

  • retreatment effective rate

    Within 56days after treatment

  • PH value of vaginae secretion

    49days

  • sIgA value of vaginae secretion

    49days

  • IL-1βvalue of vaginae secretion

    49days

Study Arms (2)

Chinese Herbal Compound Ointment

EXPERIMENTAL

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.

Drug: Chinese Herbal Compound Ointment

Estriol

ACTIVE COMPARATOR

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.

Drug: Estriol

Interventions

Chinese Herbal Compound OintmentDRUG
Chinese Herbal Compound Ointment
EstriolDRUG
Estriol

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun-yat Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Atrophic Vaginitis

Interventions

Estriol

Condition Hierarchy (Ancestors)

VaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Xin Zhou, master

CONTACT

13533259616myeva520@163.com

Bao-guo Sun, Doctor

CONTACT

13316134352Sunbaoguo666@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2016

First Posted

April 11, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

April 11, 2016

Record last verified: 2016-03

Locations

CN(1)