Clinical trial NCT03446443: Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Official title: The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bacterial Vaginitis
Lead sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Beijing Compete Pharmaceutical Co., Ltd.
name: Shandong Buchang Pharmaceutical Co., Ltd.
First posted: 2018-02-26
Enrollment: 240
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized, Positive -Controlled, Multi-center Trial enrolling 240 subjects with Bacterial Vaginosis who will be randomized at a ratio of 1:1 to receive active Honghe Fujie lotion or Metronidazole Suppositories. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.


Eligibility criteria: Inclusion Criteria:

1. Premenopausal women with sex history.
2. Age: 20 - 50 years.
3. Clinical diagnosis of Bacterial Vaginosis.
4. Nugent scale ≥7.
5. Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

1. Evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, VVC, suspected gonorrhea，HSV infection and pointed condyloma etc.).
2. Pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva（e.g. Vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.).
3. Server gynecopathy（e.g. Gynecological malignant tumor etc.）.
4. Liver function impairment with the value of ALT or AST over 2-fold of normal value.Renal dysfunction with the value of serum creatinine over normal value.
5. Patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system).
6. Receiving locally applied drugs within 1 week or currently using vaginal medicines.
7. Significant drug or alcohol abuse or a history of mental illness patients.
8. Researchers determine poor adherence, or any other unsuitable reasons for patients to participate in this study.
9. Diagnosis with other disease that necessities immunosuppressant or hormone therapy.
10. Pregnancy, breast feeding and the possible pregnancy during study. Patient who is participating in other trials or has been participated in other trials in recent 1 months.
11. Allergic to one or more components of study medicine.

Primary outcomes:
measure: The percentage of patients with remission according to Nugent score < 7
timeFrame: 28 days after the end of treatment
Secondary outcomes:
measure: Change of Nugent score
timeFrame: 3 days, 28 days after the end of treatment compare with baseline
measure: Pattern of Chinese medicine symptoms
timeFrame: 0,3 days after the end of treatment
measure: The pH of vaginal secretions
timeFrame: 0,3 days, 28 days after the end of treatment
measure: H2O2 concentration of vaginal secretions
timeFrame: 0,3 days, 28 days after the end of treatment
Other outcomes:
measure: Number of participants with AEs
timeFrame: from the first dose to 28 days after the end of treatment
Locations:
city: Beijing
country: China
facility: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
city: Kunming
country: China
facility: Yunnan first people's hospital of Yunnan Province
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Xianyang
country: China
facility: Second affiliated hospital of shaanxi university of traditional Chinese medicine
city: Xining
country: China
facility: Qinghai Red Cross Hospital
Study officials:
References: