NCT03446443

Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-07-26
• Primary completion: 2019-07-31
• Completion: 2020-02-28
• First posted: 2018-02-26
• Last updated: 2019-02-15

Locations

8 sites across 1 country: China