EUCTR2020-002489-15-SK进行中（未招募）1 期
Comparative study of the efficacy and safety of vaginally applied Dequalinium Chloride (10 mg) and orally applied Metronidazole (2 x 500 mg) in the treatment of bacterial vaginosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Medinova AG
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Premenopausal woman =18 years
- •2. Diagnosis of bacterial vaginosis (all 4 Amsel criteria positive, i.e. 1) greyish white thin discharge, 2) KOH test or ‘fishy’ smell, 3) microscopic presence of > 20% clue cells, 4) vaginal pH > 4.5)
- •3. Signed Written Informed Consent to participate in this study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 236
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnancy and/or lactation based on urine Pregnancy test (women with childbearing potential should use any contraception excluding vaginal methods like vaginal ring, etc.)
- •2. Uterine bleeding (including menstruation) or vaginal bleeding of unknown origin
- •3. Ulcerations/erosions of vaginal mucosa or cervix uteri
- •4. Patients with clinical symptoms and findings of Candida vulvovaginitis and/or Aerobic vaginitis
- •5. Clinically manifest or suspicion of STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, or Trichomonas vaginalis) based on signs, symptoms, and anamnesis
- •6. Use of any antimicrobial treatment (local or systemic) 14 days before entry the study
- •7. Use of any vaginal medication or vaginal douching 7 days before entry the study
- •8. Unwillingness to refrain from alcohol consumption during treatment, and 48 hours after treatment
- •9. Severe systemic diseases (HIV, cancer, tuberculosis, autoimmune diseases, diabetes mellitus, severe psychiatric conditions, etc.), including diseases treated with immunosuppressive therapies, systemic corticosteroids, or warfarin
- •10. Known or suspected hypersensitivity to one of the study medications, inclusive of their excipients
- •11. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (including inability to fill-in electronic patient diary)
- •12. Participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study
- •13. Patient is relative of, or staff directly reporting to, the investigator
研究者
相似试验
招募中
1 期
Ayurvedic management of diabetesCTRI/2019/03/017952All India Institute of Ayurveda
尚未招募
3 期
Comparison of Ash gourd consumption orally and Kunjal Kriya in reducing the symptoms of Acidity.CTRI/2024/05/067115Ch.Brahm Prakash Ayurved Charak Sansthan
尚未招募
2 期
Ayurvedic management regime of Ankylosing Spondylitis.CTRI/2019/06/019786All India Institute of Ayurveda
尚未招募
4 期
Comparison of various antihypertensive medicines in patients of high blood pressureCTRI/2018/05/014011Jawaharlal Nehru Medical College
已完成
2 期
A clinical trial to study the effects of Vamana karma and Maricha choorna in the patients of sheetapitta (Urticaria).CTRI/2021/01/030495All India Institute of Ayurveda30