CTRI/2024/10/074616招募中不适用
Shatavari In Women Sexual Wellness: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled, Efficacy and Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Mean change in scores for Female Sexual Function Index (FSFI) from baseline.
研究概览
简要总结
· All eligible subjects who meet the inclusion and exclusion criteria will be part of the study.
· Subjects will be informed about the purpose of the study and signed informed consent will be taken.
· All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, and visit 3 (week 8) ± 4 days.
· Blood sampling for efficacy and safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 3 (week 8).
The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women between 18 to 55 years of age.
- •2.Women willing to have 4 or more attempts of sexual intercourse each month.
- •3.Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
- •4.Participants who are reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them as per investigator’s opinion.
- •5.Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
- •6.Able to read and write in English or any other vernacular language.
- •7.No plan to commence new treatments over the study period.
- •8.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- •1.Participants taking any form of herbal extract in the last 3 months before study entry.
- •2.Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- •3.Participants with any active medical, surgical, or gynaecological problems.
- •4.Participants with a history of alcohol, tobacco dependence, or any other substance abuse 5.Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.
- •6.Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
结局指标
主要结局
Mean change in scores for Female Sexual Function Index (FSFI) from baseline.
时间窗: Mean change in scores for Female Sexual Function Index (FSFI) from baseline.
次要结局
- Mean change in scores for Satisfying Sexual Events (SSEs) from baseline.(Baseline, Week 4, Week 8)
- Mean change in scores for Female Sexual Distress Scale (FSDS) from baseline.(Baseline, Week 4, Week 8)
- Mean change in Profile of Mood States (POMS, abbreviated version) questionnaire scores from baseline(Baseline, Week 4, Week 8)
- Mean change in Oxford Happiness Questionnaire (OHQ) scores from baseline.(Baseline, Week 4, Week 8)
- Mean change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire from baseline.(Baseline, Week 4, Week 8)
- Mean change in Serum Hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.(Baseline, Week 8)
- Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.(Baseline, Week 8)
- Mean change in Thyroid (T3, T4, TSH) parameters from baseline.(Baseline, Week 8)
- Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline.(Baseline, Week 8)
- Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.(Baseline, Week 4, Week 8)
- Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.(Baseline, Week 4, Week 8)
研究者
Dr Suprlya Mahajan
Tieten Medi city Hospital
研究点 (1)
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