Bacterial VaginitisPhase 4NCT03446443
Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
A Phase 4 study testing Honghe Fujie lotion and Metronidazole Suppositories in people with Bacterial Vaginitis, run by Dongfang Hospital Beijing University of Chinese Medicine at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginitis
- What is being tested?
- Honghe Fujie lotion and Metronidazole Suppositories
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesChina
- Study dates
- 26 Jul 2018to 28 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women with sex history.
- Age: 20 - 50 years.
- Clinical diagnosis of Bacterial Vaginosis.
- Nugent scale ≥7.
- Patient is willing to participate voluntarily and to sign a written patient informed consent.
Who cannot join
- Evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, VVC, suspected gonorrhea，HSV infection and pointed condyloma etc.).
- Pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva（e.g. Vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.).
- Server gynecopathy（e.g. Gynecological malignant tumor etc.）.
- Liver function impairment with the value of ALT or AST over 2-fold of normal value.Renal dysfunction with the value of serum creatinine over normal value.
- Patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system).
- Receiving locally applied drugs within 1 week or currently using vaginal medicines.
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- Significant drug or alcohol abuse or a history of mental illness patients.
- Researchers determine poor adherence, or any other unsuitable reasons for patients to participate in this study.
- Diagnosis with other disease that necessities immunosuppressant or hormone therapy.
- Pregnancy, breast feeding and the possible pregnancy during study. Patient who is participating in other trials or has been participated in other trials in recent 1 months.
- Allergic to one or more components of study medicine.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Beijing, 100078
Zhe Jin, MD
Zhe Jin, professor
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing
Qinping Liao, MD
Qinping Liao, MD
- Not yet recruiting
Peking University First Hospital
Beijing
Zhaohui Liu, MD
Zhaohui Liu
- Not yet recruiting
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu
Shaobin Wei
- Not yet recruiting
Yunnan first people's hospital of Yunnan Province
Kunming
Rong Zi
- Not yet recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an
Ruifang An
- Not yet recruiting
Second affiliated hospital of shaanxi university of traditional Chinese medicine
Xianyang
Qin Li
- Not yet recruiting
Qinghai Red Cross Hospital
Xining
Ying Lou
About this study
Official title: The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
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
- Being tested
- Honghe Fujie lotion, Metronidazole Suppositories
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honghe Fujie lotionDrug
Also called Hawthorn nuclear extract
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.
Metronidazole SuppositoriesDrug
Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.
| Study group | Role | What they receive |
|---|---|---|
| Honghe Fujie lotion group | Experimental | Not described Receives: Drug: Honghe Fujie lotion |
| Metronidazole Suppositories group | Active comparator | Not described Receives: Drug: Metronidazole Suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after the end of treatment
Secondary outcomes (4)
Change of Nugent score
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.
Measured: 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
Measured: 0,3 days after the end of treatment
The pH of vaginal secretions
using pH test paper for measuring the pH of vaginal secretions
Measured: 0,3 days, 28 days after the end of treatment
H2O2 concentration of vaginal secretions
the concentration of hydrogen peroxide in the vaginal secretions
Measured: 0,3 days, 28 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start26 Jul 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Beijing Compete Pharmaceutical Co., Ltd., Shandong Buchang Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446443
- Sponsor's protocol ID
- KPT-RCT-2017-01
- Status last verified
- Feb 2019
- First submitted
- 11 Jan 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT03446443
- Acronym / sponsor ID
- KPT-RCT-2017-01
- Conditions
- Bacterial Vaginitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Dongfang Hospital Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Beijing Compete Pharmaceutical Co., Ltd., Shandong Buchang Pharmaceutical Co., Ltd.
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 26 Feb 2018 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Honghe Fujie lotion group | Experimental | Drug: Honghe Fujie lotion |
| Metronidazole Suppositories group | Active comparator | Drug: Metronidazole Suppositories |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Premenopausal women with sex history.
- Age: 20 - 50 years.
- Clinical diagnosis of Bacterial Vaginosis.
- Nugent scale ≥7.
- Patient is willing to participate voluntarily and to sign a written patient informed consent.
Key exclusion criteria (11 listed)
- Evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, VVC, suspected gonorrhea，HSV infection and pointed condyloma etc.).
- Pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva（e.g. Vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.).
- Server gynecopathy（e.g. Gynecological malignant tumor etc.）.
- Liver function impairment with the value of ALT or AST over 2-fold of normal value.Renal dysfunction with the value of serum creatinine over normal value.
- Patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system).
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 |
|---|---|---|
| Honghe Fujie lotionAlso: Hawthorn nuclear extractBefore 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 | Honghe Fujie lotion group |
| Metronidazole SuppositoriesBefore bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days. | Drug | Metronidazole Suppositories group |
Primary outcome
The percentage of patients with remission according to Nugent score < 7
Time frame: 28 days after the end of treatment
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.
4 secondary outcomes
Change of Nugent score
Time frame: 3 days, 28 days after the end of treatment compare with baseline
Pattern of Chinese medicine symptoms
Time frame: 0,3 days after the end of treatment
The pH of vaginal secretions
Time frame: 0,3 days, 28 days after the end of treatment
H2O2 concentration of vaginal secretions
Time frame: 0,3 days, 28 days after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Honghe Fujie lotion and Metronidazole Suppositories in people with Bacterial Vaginitis, run by Dongfang Hospital Beijing University of Chinese Medicine at 8 sites 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Jin, MD (8613601382390, zill01@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with remission according to Nugent score < 7 (time frame: 28 days after the end of treatment). 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 15 Feb 2019.