Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

Bacterial Vaginitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03446443
• Other study ID #: KPT-RCT-2017-01
• Status: Recruiting
• Phase: Phase 4
• Start date: July 26, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: February 2019
• Source: Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
• Contact: Zhe Jin, MD
• Phone: 8613601382390
• Email: zill01[@]126.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 28, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Vaginitis
• Vaginitis
• Vaginosis, Bacterial

Intervention

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.
• Metronidazole Suppositories
Before bedtime,wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix,once daily for 7days.

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing
China	Dongfang Hospital Affiliated to Beijing University of Chinese Medicine	Beijing
China	Peking University First Hospital	Beijing
China	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu
China	Yunnan first people's hospital of Yunnan Province	Kunming
China	The First Affiliated Hospital of Xian Jiaotong University	Xi'an
China	Second affiliated hospital of shaanxi university of traditional Chinese medicine	Xianyang
China	Qinghai Red Cross Hospital	Xining

Sponsors (4)

Lead Sponsor	Collaborator
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine	Beijing Compete Pharmaceutical Co., Ltd., Peking University First Hospital, Shandong Buchang Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	H2O2 concentration of vaginal secretions	the concentration of hydrogen peroxide in the vaginal secretions	0,3 days, 28 days after the end of treatment