VaginitisPhase 3NCT04574089
Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository
A Phase 3 study testing Experimental: Baofukang Suppository 7 days and Experimental: Baofukang Suppository 14 days in people with Vaginitis, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Vaginitis
- What is being tested?
- Experimental: Baofukang Suppository 7 days and Experimental: Baofukang Suppository 14 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aerobic vaginitis diagnosed based on present ：
- Vaginal dischareg ;
- pH > 4.5;
- Donders score≥3;
Who cannot join
- Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases;
- Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission.
- Pregnancy, lactation and intentional pregnancy;
- Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases;
- Allergic constitution and patients allergic to drug ingredients in this study;
- Those with poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hosptal
Shenzhen, Guangdong, 518036
About this study
Official title: Medical Ethics Committee of Peking University Shenzhen Hospital
Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment.
Read the detailed description
Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.
Group 1: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 7 days.
Group 2: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 14 days.
The efficacy and safety will be evaluated 7~14 days after treatment and 35~42 days after treatment.
- Conditions
- Vaginitis
- Being tested
- Experimental: Baofukang Suppository 7 days, Experimental: Baofukang Suppository 14 days
- Keywords
- Aerobic vaginitis, Treatment
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Baofukang Suppository 7 daysDrug
Also called Baofukang Suppository 7 days
Experimental: Baofukang Suppository 7 days
Experimental: Baofukang Suppository 14 daysDrug
Also called Baofukang Suppository 14 days
Experimental: Baofukang Suppository 14 days
| Study group | Role | What they receive |
|---|---|---|
| Baofukang Suppository 7 days | Experimental | Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 7 days Receives: Drug: Experimental: Baofukang Suppository 7 days |
| Baofukang Suppository 14 days | Experimental | Baofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 14days Receives: Drug: Experimental: Baofukang Suppository 14 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
A vaginal smear composite Donders score of 1 to 2 represents normality. A score of more than 2 is aerobic vaginitis. There are four variables(Lactobacillary; leucocytes; toxic leukocytes; parabasal cells; background flora). Detail see references Links.
Measured: First week after treatment
Cure rate
A vaginal smear composite Donders score of 1 to 2 represents normality. A score of more than 2 is aerobic vaginitis. There are four variables(Lactobacillary; leucocytes; toxic leukocytes; parabasal cells; background flora).Detail see folowing references.
Measured: First month after the treatment
Secondary outcomes (1)
Side affect
Number of Participants Experiencing AEs Following the First Dose of the Study Product
Measured: First week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 May 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shangrong Fan, Peking University Shenzhen Hospital
- Investigators
- Shangrong Fan, M.D., Principal investigator, Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574089
- Sponsor's protocol ID
- PUShenzhenH
- Status last verified
- Jun 2025
- First submitted
- 20 Feb 2020
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Ethics Committee of Peking University Shenzhen Hospital
- ClinicalTrials.gov ID
- NCT04574089
- Acronym / sponsor ID
- PUShenzhenH
- Conditions
- Vaginitis
- Keywords
- Aerobic vaginitis, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment.
Detailed description
Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.
Group 1: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 7 days.
Group 2: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 14 days.
The efficacy and safety will be evaluated 7~14 days after treatment and 35~42 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baofukang Suppository 7 days | Experimental | Drug: Experimental: Baofukang Suppository 7 daysBaofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 7 days |
| Baofukang Suppository 14 days | Experimental | Drug: Experimental: Baofukang Suppository 14 daysBaofukang Suppository (1.74g), for vaginal external use, 2 capsules per night for 14days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aerobic vaginitis diagnosed based on present ：
- Vaginal dischareg ;
- pH > 4.5;
- Donders score≥3;
Key exclusion criteria (6 listed)
- Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases;
- Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission.
- Pregnancy, lactation and intentional pregnancy;
- Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases;
- Allergic constitution and patients allergic to drug ingredients in this study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Baofukang Suppository 7 daysAlso: Baofukang Suppository 7 daysExperimental: Baofukang Suppository 7 days | Drug | Baofukang Suppository 7 days |
| Experimental: Baofukang Suppository 14 daysAlso: Baofukang Suppository 14 daysExperimental: Baofukang Suppository 14 days | Drug | Baofukang Suppository 14 days |
Primary outcome
Cure rate
Time frame: First week after treatment
A vaginal smear composite Donders score of 1 to 2 represents normality. A score of more than 2 is aerobic vaginitis. There are four variables(Lactobacillary; leucocytes; toxic leukocytes; parabasal cells; background flora). Detail see references Links.
Cure rate
Time frame: First month after the treatment
A vaginal smear composite Donders score of 1 to 2 represents normality. A score of more than 2 is aerobic vaginitis. There are four variables(Lactobacillary; leucocytes; toxic leukocytes; parabasal cells; background flora).Detail see folowing references.
1 secondary outcome
Side affect
Time frame: First week after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- AV diagnosis and outcome MeasureLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Vaginitis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
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)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shangrong Fan, M.D. principal investigator
Dept of Obstetrics and Gynecology,Peking University Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: Baofukang Suppository 7 days and Experimental: Baofukang Suppository 14 days in people with Vaginitis, run by Peking University Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ping Liu, M.D. (86755-83923333 ext. 5505, 253783006@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: First week after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.