Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-26

Study Completion Date

2020-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Vaginitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Honghe Fujie lotion group

Group Type EXPERIMENTAL

Honghe Fujie lotion

Intervention Type DRUG

Before application，wash the vaginal area with water and dry it. Take10ml Hong He Fujie into dilution bottles，added to 100ml with warm boiled water, using diluted lotion for the rinse of vulva and vagina, twice daily for 7days.

Metronidazole Suppositories group

Group Type ACTIVE_COMPARATOR

Metronidazole Suppositories

Intervention Type DRUG

Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.

Interventions

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Honghe Fujie lotion

Before application，wash the vaginal area with water and dry it. Take10ml Hong He Fujie into dilution bottles，added to 100ml with warm boiled water, using diluted lotion for the rinse of vulva and vagina, twice daily for 7days.

Intervention Type DRUG

Metronidazole Suppositories

Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.

Intervention Type DRUG

Other Intervention Names

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Hawthorn nuclear extract

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, , China

Site Status RECRUITING