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Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

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ClinicalTrials.gov Identifier: NCT03446443
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Peking University First Hospital
Beijing Compete Pharmaceutical Co., Ltd.
Shandong Buchang Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Dongfang Hospital Beijing University of Chinese Medicine

Brief 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. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.

Condition or disease Intervention/treatment Phase
Bacterial Vaginitis Drug: Honghe Fujie lotion Drug: Metronidazole Suppositories Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
Actual Study Start Date : July 26, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Honghe Fujie lotion group Drug: Honghe Fujie lotion
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.
Other Name: Hawthorn nuclear extract

Active Comparator: Metronidazole Suppositories group Drug: Metronidazole Suppositories
Before bedtime,wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix,once daily for 7days.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change of Nugent score [ Time Frame: 3 days, 28 days after the end of treatment compare with baseline ]
    The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.

  2. Pattern of Chinese medicine symptoms [ Time Frame: 0,3 days after the end of treatment ]
    according to an inquiry list from the perspective of traditional Chinese medicine

  3. The pH of vaginal secretions [ Time Frame: 0,3 days, 28 days after the end of treatment ]
    using pH test paper for measuring the pH of vaginal secretions

  4. H2O2 concentration of vaginal secretions [ Time Frame: 0,3 days, 28 days after the end of treatment ]
    the concentration of hydrogen peroxide in the vaginal secretions


Other Outcome Measures:
  1. Number of participants with AEs [ Time Frame: from the first dose to 28 days after the end of treatment ]
    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.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Premenopausal women with sex history.
  2. Age: 20 - 50 years.
  3. Clinical diagnosis of Bacterial Vaginosis.
  4. Nugent scale ≥7.
  5. Patient is willing to participate voluntarily and to sign a written patient informed consent.

Exclusion Criteria:

  1. Evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, VVC, suspected gonorrhea,HSV infection and pointed condyloma etc.).
  2. Pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva(e.g. Vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.).
  3. Server gynecopathy(e.g. Gynecological malignant tumor etc.).
  4. 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.
  5. Patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system).
  6. Receiving locally applied drugs within 1 week or currently using vaginal medicines.
  7. Significant drug or alcohol abuse or a history of mental illness patients.
  8. Researchers determine poor adherence, or any other unsuitable reasons for patients to participate in this study.
  9. Diagnosis with other disease that necessities immunosuppressant or hormone therapy.
  10. 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.
  11. Allergic to one or more components of study medicine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446443


Contacts
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Contact: Zhe Jin, MD 8613601382390 zill01@126.com
Contact: Bin Xu, MD 8615701005080 dbab1983@hotmail.com

Locations
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China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine Recruiting
Beijing, China, 100078
Contact: Zhe Jin, MD         
Principal Investigator: Zhe Jin, professor         
Beijing Tsinghua Changgung Hospital Not yet recruiting
Beijing, China
Contact: Qinping Liao, MD         
Principal Investigator: Qinping Liao, MD         
Peking University First Hospital Not yet recruiting
Beijing, China
Contact: Zhaohui Liu, MD         
Principal Investigator: Zhaohui Liu         
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine Not yet recruiting
Chengdu, China
Contact: Shaobin Wei         
Yunnan first people's hospital of Yunnan Province Not yet recruiting
Kunming, China
Contact: Rong Zi         
The First Affiliated Hospital of Xian Jiaotong University Not yet recruiting
Xi'an, China
Contact: Ruifang An         
Second affiliated hospital of shaanxi university of traditional Chinese medicine Not yet recruiting
Xianyang, China
Contact: Qin Li         
Qinghai Red Cross Hospital Not yet recruiting
Xining, China
Contact: Ying Lou         
Sponsors and Collaborators
Dongfang Hospital Beijing University of Chinese Medicine
Peking University First Hospital
Beijing Compete Pharmaceutical Co., Ltd.
Shandong Buchang Pharmaceutical Co., Ltd.

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Responsible Party: Dongfang Hospital Beijing University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03446443     History of Changes
Other Study ID Numbers: KPT-RCT-2017-01
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginitis
Bacterial Infections
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents