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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
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.
Before bedtime,wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix,once daily for 7days.
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, China
RECRUITINGBeijing Tsinghua Changgung Hospital
Beijing, China
NOT_YET_RECRUITINGPeking University First Hospital
Beijing, China
The percentage of patients with remission according to Nugent score < 7
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid,calculated by assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) . Nugent score is is the addition of these three sub scales,and can range from 0 to 10.
Time frame: 28 days after the end of treatment
Change of Nugent score
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Time frame: 3 days, 28 days after the end of treatment compare with baseline
Pattern of Chinese medicine symptoms
according to an inquiry list from the perspective of traditional Chinese medicine
Time frame: 0,3 days after the end of treatment
The pH of vaginal secretions
using pH test paper for measuring the pH of vaginal secretions
Time frame: 0,3 days, 28 days after the end of treatment
H2O2 concentration of vaginal secretions
the concentration of hydrogen peroxide in the vaginal secretions
Time frame: 0,3 days, 28 days after the end of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, China
NOT_YET_RECRUITINGYunnan first people's hospital of Yunnan Province
Kunming, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
NOT_YET_RECRUITINGSecond affiliated hospital of shaanxi university of traditional Chinese medicine
Xianyang, China
NOT_YET_RECRUITINGQinghai Red Cross Hospital
Xining, China
NOT_YET_RECRUITING