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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Beijing Compete Pharmaceutical Co., Ltd. | UNKNOWN |
| Shandong Buchang Pharmaceutical Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honghe Fujie lotion group | Experimental |
| |
| Metronidazole Suppositories group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honghe Fujie lotion | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Nugent score | The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid. | 3 days, 28 days after the end of treatment compare with baseline |
| Pattern of Chinese medicine symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from the first dose to 28 days after the end of treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhe Jin, MD | Contact | 8613601382390 | zill01@126.com | |
| Bin Xu, MD | Contact | 8615701005080 | dbab1983@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongfang Hospital Affiliated to Beijing University of Chinese Medicine | Recruiting | Beijing | 100078 | China |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| Metronidazole Suppositories | Drug | Before bedtime,wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix,once daily for 7days. |
|
according to an inquiry list from the perspective of traditional Chinese medicine
| 0,3 days after the end of treatment |
| The pH of vaginal secretions | using pH test paper for measuring the pH of vaginal secretions | 0,3 days, 28 days after the end of treatment |
| H2O2 concentration of vaginal secretions | the concentration of hydrogen peroxide in the vaginal secretions | 0,3 days, 28 days after the end of treatment |
| Beijing Tsinghua Changgung Hospital | Not yet recruiting | Beijing | China |
|
| Peking University First Hospital | Not yet recruiting | Beijing | China |
|
| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Not yet recruiting | Chengdu | China |
|
| Yunnan first people's hospital of Yunnan Province | Not yet recruiting | Kunming | China |
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| The First Affiliated Hospital of Xian Jiaotong University | Not yet recruiting | Xi'an | China |
|
| Second affiliated hospital of shaanxi university of traditional Chinese medicine | Not yet recruiting | Xianyang | China |
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| Qinghai Red Cross Hospital | Not yet recruiting | Xining | China |
|
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |