Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis

Last updated: February 13, 2019
Sponsor: Dongfang Hospital Beijing University of Chinese Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

Vaginal Infection

Vaginitis

Treatment

N/A

Clinical Study ID

NCT03446443
KPT-RCT-2017-01
  • Ages 20-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 informedconsent.

Exclusion

Exclusion Criteria:

  1. Evidence of other female genital tractor infectious diseases (e.g. trichomonasvaginitis, 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 normalvalue.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 toparticipate 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 isparticipating in other trials or has been participated in other trials in recent 1months.

  11. Allergic to one or more components of study medicine.

Study Design

Total Participants: 240
Study Start date:
July 26, 2018
Estimated Completion Date:
February 28, 2020

Connect with a study center

  • Beijing Tsinghua Changgung Hospital

    Beijing,
    China

    Site Not Available

  • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

    Beijing, 100078
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu,
    China

    Site Not Available

  • Yunnan first people's hospital of Yunnan Province

    Kunming,
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an,
    China

    Site Not Available

  • Second affiliated hospital of shaanxi university of traditional Chinese medicine

    Xianyang,
    China

    Site Not Available

  • Qinghai Red Cross Hospital

    Xining,
    China

    Site Not Available

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