TrialReader


Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

NCT03446443 — Phase 4, Unknown, 240 participants, Dongfang Hospital Beijing University of Chinese Medicine

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

RegistryNCT03446443
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment240 (Estimated)
SponsorDongfang Hospital Beijing University of Chinese Medicine (Other); collaborators: Peking University First Hospital, Beijing Compete Pharmaceutical Co., Ltd., Shandong Buchang Pharmaceutical Co., Ltd.
ConditionsBacterial Vaginitis
InterventionsHonghe Fujie lotion, Metronidazole Suppositories (Drug)
Datesstart 2018-07-26, primary completion 2019-07-31 (estimated), completion 2020-02-28 (estimated), first posted 2018-02-26, last updated 2019-02-15
Locations8 sites in China

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Bacterial Vaginitis All trials of Honghe Fujie lotion All trials of Metronidazole Suppositories

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Honghe Fujie lotion groupExperimentalDrug: Honghe Fujie lotion
Metronidazole Suppositories groupActive comparatorDrug: Metronidazole Suppositories
  • Honghe Fujie lotion (Drug), also known as 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 Suppositories (Drug): Before bedtime,wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix,once daily for 7days.

+Outcome measures

Primary outcomes

  • The percentage of patients with remission according to Nugent score < 7 [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 outcomes

  • Change of Nugent score [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.
  • Pattern of Chinese medicine symptoms [0,3 days after the end of treatment]: according to an inquiry list from the perspective of traditional Chinese medicine
  • The pH of vaginal secretions [0,3 days, 28 days after the end of treatment]: using pH test paper for measuring the pH of vaginal secretions
  • H2O2 concentration of vaginal secretions [0,3 days, 28 days after the end of treatment]: the concentration of hydrogen peroxide in the vaginal secretions

Other outcomes

  • Number of participants with AEs [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.

+Eligibility

Sex: Female, ages: 20 Years to 50 Years

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.

+Locations (8)

FacilityCityCountryStatus
Dongfang Hospital Affiliated to Beijing University of Chinese MedicineBeijingChinaRecruiting
Beijing Tsinghua Changgung HospitalBeijingChinaNot yet recruiting
Peking University First HospitalBeijingChinaNot yet recruiting
Affiliated Hospital of Chengdu University of Traditional Chinese MedicineChengduChinaNot yet recruiting
Yunnan first people's hospital of Yunnan ProvinceKunmingChinaNot yet recruiting
The First Affiliated Hospital of Xian Jiaotong UniversityXi'anChinaNot yet recruiting
Second affiliated hospital of shaanxi university of traditional Chinese medicineXianyangChinaNot yet recruiting
Qinghai Red Cross HospitalXiningChinaNot yet recruiting

My Notes