A randomized, blind, positive-controlled, multicenter study to evaluate the efficacy and safety of Compound Furong effervescent suppository in the treatment of bacterial vaginosis combined with aerobi

Phase 4

• Conditions: Bacterial vaginosis combined with aerobic vaginitis

• Registration Number: ITMCTR1900002767
• Lead Sponsor: Beijing Tsinghua Changgeng Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Clinical diagnosis of Bacterial Vaginosis combined with aerobic vaginitis;
2. conforms to the syndrome differentiation standard of TCM dampness-heat bet syndrome;
3. Donders score >= 3, <=6;
4. Nugent score >= 7;
5. Aged >= 20, <= 55 years, sexual life history;
6. The patient is willing to participate voluntarily and to sign the informed consent.

Exclusion Criteria

1. Combined with other vaginitis such as trichomoniasis vaginitis, vulvovaginal candidiasis, or suspected gonorrhea, herpes simplex virus infection caused by reproductive tract infection;
2. Patients with other serious gynecological diseases, such as gynecological malignant tumor and pelvic inflammatory disease;
3. Patients with serious primary diseases such as heart, brain, liver, kidney, blood system and endocrine system, among which ALT or AST over 2-fold of normal value or Scr over normal value.
4. Patients who received any oral or external drug treatment for this disease within one week before enrollment;
5. Pregnancy, breast feeding and the possible pregnancy during study;
6. Those who are known to be allergic to the components of experimental drugs;
7. Persons who have combined neurological or mental disorders and are unable to cooperate, and who suspect or have a history of alcohol or drug abuse;
8. Patient who is participating in other trials or has been participated in other trials in recent 1 months before screen;
9. Not suitable for this study judged by investigater.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease recovery rate;

Secondary Outcome Measures

Name	Time	Method
Recurrence rate;The percentage of patients with Nugent score < 7;Individual symptom score;Chinese medicine symptom complex score;Functional indicators of vaginal flora;Change of lactobacillus;The percentage of patients with Donders score < 3;