Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

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.

Study Overview

• Status: Unknown
• Conditions: Bacterial Vaginitis
• Intervention / Treatment: Drug: Honghe Fujie lotion; Drug: Metronidazole Suppositories

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
• Collaborators: Peking University First Hospital; Beijing Compete Pharmaceutical Co., Ltd.; Shandong Buchang Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2018
• Primary Completion (Anticipated): July 31, 2019
• Study Completion (Anticipated): February 28, 2020

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginal Diseases; Vaginitis; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: KPT-RCT-2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No