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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002767
Enrollment
Unknown
Registered
2019-11-21
Start date
2019-12-02
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis combined with aerobic vaginitis

Interventions

Sponsors

Beijing Tsinghua Changgeng Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 55 Years

Inclusion criteria

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, = 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

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.

Design outcomes

Primary

MeasureTime frame
Disease recovery rate;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactQinping Liao
13701124527@163.com+86 13701124527

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026