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Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

NCT03446443 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginitis

Interventions

DRUG

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.

DRUG

Metronidazole Suppositories

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

Sponsors & Collaborators

  • Peking University First Hospital

    collaborator OTHER

  • Beijing Compete Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Shandong Buchang Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Dongfang Hospital Beijing University of Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2019-07-31
Completion
2020-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03446443 on ClinicalTrials.gov