CTRI/2022/03/041393已完成2 期
A Multicentre, Randomized, Double blind, Placebo controlled Pilot Study to evaluate the Efficacy and Safety of Colloidal Nano Silver Gel (SilverSol®) in the treatment of Bacterial Vaginosis, VulvovaginalCandidiasis and Trichomoniasis
Viridis BioPharma Pvt Ltd3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月4日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Proportion of subjects achieving clinical cure at end of study Visit.
研究概览
简要总结
This study is A Phase II, Multicentre, Randomized, Double blind, Placebo controlled Clinical Study to evaluate the Efficacy and Safety of Colloidal Nano Silver Gel (SilverSol®) in the treatment of Bacterial Vaginosis, Vulvovaginal Candidiasis and Trichomoniasis
The objective is to evaluate the efficacy an safety of Colloidal Nano Silver Gel (SilverSol®) in the treatment of Bacterial Vaginosis, Vulvovaginal Candidiasis and Trichomoniasis.
Primary Endpoint:
-Proportion of subjects achieving clinical cure at end of study Visit.
Secondary Endpoint
Proportion of subjects achieving microbiological cure at end of study Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Postmenarchal female subjects between 18 to 65 years of age (Both Inclusive).
- •Subjects must have a confirmed clinical diagnosis of vaginal infection with any one, two or all of the following inclusion criteria- a) Diagnosis of bacterial vaginosis based on the presence of all four Amsel criteria.Homogeneous vaginal discharge (off white, milky or gray, thin), positive KOH whiff test,vaginal secretions,pH of > 4.5, Clue cells ≥ 20 percent of vaginal squamous epithelial cells on saline wet mount.
- •And/or b) Diagnosis of Vulvovaginal Candidiasis(VVC) demonstrating presence of yeast forms (hyphae or pseudohyphae) or budding yeasts on the KOH or saline preparation from the inflamed vaginal mucosa or secretions with two or more signs and symptoms of VVC and Vaginal pH less than or equal to 4.5.(Signs: edema, redness, or excoriation.
- •Symptoms: itching, burning, and/or irritation) And/or c) Diagnosis of Trichomoniasis at the screening visit as determined by Positive wet mount assessment for Trichomonas vaginalis with any one of the symptoms (i.e. itching, discharge and odor).
- •Subjects who agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays,Spermicides, tampons, and diaphragms).
- •Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •Subjects with other infectious causes of vulvovaginitis e.g Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex.
- •Presence of any condition or illness, including vulvar and vaginal conditions, that in the opinion of the investigator would preclude accurate evaluation of the subject’s condition and/or confound the interpretation of the subject’s treatment response.
- •Subject with history of cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
- •Subjects using systemic (oral, intravenous [IV], or intramuscular [IM]), intravaginal/ vulvovaginal antifungal, antimicrobial, or corticosteroid therapy within 14 days of participation in the study.
- •Subjects who are currently on any anticoagulation therapy or immunosuppressive therapy.
- •Pregnant, lactating, or planning to become pregnant during the study period.
- •Use of any investigational drug within 30 days of enrollment or plans to use other investigational products while enrolled in the study
- •History of hypersensitivity to Colloidal Silver or any other ingredient of the formulations.
结局指标
主要结局
Proportion of subjects achieving clinical cure at end of study Visit.
时间窗: 15 days
次要结局
- Proportion of subjects achieving microbiological cure at end of study Visit.(15 days)
- The assessment of safety of Investigational Product will be based on the frequency of Adverse Events.(15 days)
研究者
研究点 (3)
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