A Double Blind, Prospective, Randomized, Comparative, Placebo Controlled, Two Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of Amore-Female Sexual Wellness Drink of Sipwise Beverages Pvt. Ltd. in improving Sexual Wellness in Healthy Adult Female Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Female Sexual Function Index-FSFI-: Improvement of greater than or equal to 20% from baseline in comparison with placebo.
研究概览
简要总结
Study Design: A Double Blind, Prospective, Randomized, Comparative, Placebo Controlled, Two Arm Clinical Study.
Indication: Female Sexual Dysfunction
Investigational Product: Amore-Female Sexual Wellness Drink
Comparator: Placebo Drink
Dose or Dosage: Two bottles,two bottles of Drink to be consumed per day, preferably chilled.
Subject Population: Healthy Adult Females between the ages of 21 and 65 years -both ages inclusive- who are in a heterosexual, monogamous relationship with an active sexual life.
Number of Subjects: 40 Evaluable Subjects
Treatment Arms: Two Treatment Arms
Treatment arm I: 33 Subjects-Amore Female Sexual Wellness Drink
Treatment arm II: 11 Subjects-Placebo Drink
Assessments 1. Female Sexual Function Index-FSFI-: Day 1, Day 30, Day 602. Subject IP Feedback Questionnaire: Day 60
Background of the study:
Female sexual dysfunction (FSD) is a common condition associated with physical and psychological factors. It is caused by failure in one or more biochemical pathways that are interlinked in a complex fashion; hence medicines that have a specific target molecule fail to address the issue. This lacuna with the existing limited drugs has created the necessity to identify more alternative medicines with reduced side effects, easy availability and affordability.
Purpose of the Study
Amore – Female Sexual Wellness Drink is made with herbs with known potential to have an effect in improving sexual wellness in adult Females. Hence this clinical study is done to evaluate the safety, effectiveness and tolerability of Amore- Female sexual wellness drink in improving the sexual wellness of healthy adult female subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy Adult Females between the ages of 21 and 65 -both ages inclusive- who are in a heterosexual, monogamous relationship with an active sexual life.
- •Subjects who have scored 38 to 57 -both scores inclusive- in the Female Sexual Function Index at the time of screening.
- •Heterosexual partner to be physically living with the subject.
- •Subjects willing to practice double barrier contraceptive methods throughout the study.
- •Subjects who are willing to abstain from use of herbal, allopathic or home remedies-oral or topical-for any sexual condition not limited to aphrodisiacs, achieving and maintenance of erection, improvement in sexual life etc.
- •Subjects phenotypically female at birth and with normal presentation of genitourinary and reproductive system that allows for a normal sexual life.
- •Subjects who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
- •Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •Subjects with known hypersensitivity to the ingredients of the investigational product.
- •Subjects with history or diagnosis of psychiatric disorders
- •Subjects with history of uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •Subjects with history of seizures.
- •Subjects on remission from cancer of any type less than 5 years at the time of screening.
- •Subjects who have participated in a clinical study less than 1 month before screening.
- •Any significant medical condition-e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor-e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation.
- •Subjects who are planning a pregnancy and.
- •or currently breastfeeding.
- •Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •Subjects who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
结局指标
主要结局
1. Female Sexual Function Index-FSFI-: Improvement of greater than or equal to 20% from baseline in comparison with placebo.
时间窗: 1. Female Sexual Function Index-FSFI-: Day 1, Day 30, Day 60 | 2. Subject IP Feedback Questionnaire: Day 60
2. Subject IP Feedback Questionnaire: Total Score of greater than or equal to 20 in comparison with Placebo.
时间窗: 1. Female Sexual Function Index-FSFI-: Day 1, Day 30, Day 60 | 2. Subject IP Feedback Questionnaire: Day 60
次要结局
- Not applicable(Not applicable)