A Phase 4 interventional study of Honghe Fujie lotion and Metronidazole Suppositories in Bacterial Vaginitis, sponsored by Dongfang Hospital Beijing University of Chinese Medicine. Status unknown at 8 sites in China. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by Dongfang Hospital Beijing University of Chinese Medicine · Phase 4, Interventional, and Treatment
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Among 16 studies in Vaginosis, Bacterial with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Vaginosis, Bacterial · China.
Among the 16 studies in Vaginosis, Bacterial with a site in China, this one is the 4th largest by planned enrollment, is the only one that started in 2018, is one of 6 in phase 4, and was the 5th registered.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
Browse Vaginosis, Bacterial studies →6 of the 16 studies in Vaginosis, Bacterial with a site in China are open now. Recruiting first, the newest first:
Changchun GeneScience Pharmaceutical Co., Ltd. · Sites in China
Ages 18–50 · Women only
Zhujiang Hospital · Sites in China
Ages 18–55 · Women only
Peking University Shenzhen Hospital · Sites in China
Ages 18–55 · Women only · Healthy volunteers
SPH Sine Pharmaceutical Laboratories Co., Ltd. · Sites in China
Ages 18–55 · Women only
Chengdu Syncor Pharmaceutical Co., Ltd. · Sites in China
Ages 18–50 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 23 Vaginosis, Bacterial studies recruiting now, 7 (30%) set no upper age limit and 16 (70%) stop at 75 or younger; 2 take children under 18; 9 take healthy volunteers.
This study: 20 Years to 50 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 1 started in 2018.
This study's planned enrollment of 240 is above the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Median enrollment 123 across the 16 interventional studies. Of the 7 that completed or were terminated, 2 (29%) have results posted.
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10 of 16 have an industry lead sponsor. The 10 most frequent:
Dongfang Hospital Beijing University of Chinese Medicine is the lead sponsor of 10 studies on the registry; none are open to participants now.
Dongfang Hospital Beijing University of Chinese Medicine has 1 study filed under Vaginosis, Bacterial — fewer than ten, so there is no comparison to draw.
4 of the studies in Vaginosis, Bacterial with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04771728Peking University Shenzhen HospitalA Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis | 2026-12-01 |
| NCT07663838Changchun GeneScience Pharmaceutical Co., Ltd.A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV) | 2027-01-05 |
| NCT07483671Chengdu Syncor Pharmaceutical Co., Ltd.Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients | 2027-01-24 |
| NCT07888699SPH Sine Pharmaceutical Laboratories Co., Ltd.WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis | 2027-10-15 |
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Among the 16 studies in Vaginosis, Bacterial with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Honghe Fujie lotion
Drug: Metronidazole Suppositories
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.
Also known as: Hawthorn nuclear extract
Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.
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
Number of participants with AEs
Number of patients with AEs by treatment group and overall. The incidence of AEs will be summarized by system organ class, severity, type of AE, relation of study drug and outcome.
Time frame: from the first dose to 28 days after the end of treatment
Started Jul 2018 (actual). Primary completion is estimated for Jul 2019, 12 months after the start.
Of 17 phase 4 interventional studies under Vaginosis, Bacterial, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Dongfang Hospital Beijing University of Chinese Medicine