CTRI/2015/07/006045招募中Unknown
Efficacy Of KSM66 Ashwagandha (Withania Somnifera) In Improving the Female Sexual Function Index (FSFI) In Healthy Women with Female Sexual Dysfunction (FSD): A Prospective, Randomized, Placebo-controlled Study
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement from baseline in the total score and domain scores for Female Sexual Function Index (FSFI)
研究概览
简要总结
Experiencing problems with the sexual activities is being reported as the strongest and most consistent risk factor for women’s sexual distress in a number of studies. This study is planned to assess the efficacy of KSM66 Ashwagandha (Withania somnifera) in improving the female sexual function index (FSFI) in healthy women with female sexual dysfunction (FSD): A Prospective, Randomized, Placebo-controlled Study. In this study female patients between 21 to 50 years of age with Female Sexual Dysfunction (FSD) with baseline total score of <26 on the Female Sexual Function Index (FSFI),and baseline total score of >11 on the Female Sexual Distress Scale (FSDS) were enrolled. Study duration will be 8 weeks for each subject with baseline, week 4 & week 8 visits. Subjects were asked to take 2 capsules two times daily (total 4 capsules per day) with water daily for 8 weeks. At the end of study primary outcome will be assessed as improvement from baseline in the total score and domain scores for FSFI & secondary as improvement from baseline in the total score of sexual activity record (SAR) and FSDS. Global assessment by patient will be done at the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Females between 21 to 50 years of age 2.Have been previously “functional†or experienced sexual desire/arousal/orgasm for several years in the past 3.Have a stable heterosexual relationship with a male partner for at least 1 year 4.Have a male partner with a score of "not impotent" or "minimally impotent" on the Single-Question, Self-report of Erectile Dysfunction (Massachusetts Male Aging Study) 5.Meet the diagnostic criteria for Female Sexual Dysfunction (FSD) for any one or more of the following disorder: a.Hypoactive sexual desire disorder (HSDD) b.Female sexual arousal disorder (FSAD) c.Female orgasmic disorder (FOD) d.Combined genital and subjective arousal disorder e.Genital sexual arousal disorder 6.Have a baseline total score of <26 on the Female Sexual Function Index (FSFI) 7.Have a baseline total score of >11 on the Female Sexual Distress Scale (FSDS) 8.Willing to engage in sexual activities with intent to attain orgasm at least 2 times per week 9.Provide written informed consent 10.Willing and able to understand and comply with all study requirements.
排除标准
- •1.Evidence of unresolved sexual trauma or abuse 2.Primary anorgasmia, vaginismus, sexual pain disorder (dyspareunia), sexual aversion disorder, or persistent sexual arousal disorder 3.Chronic dyspareunia not attributable to vaginal dryness within previous 12 months 4.Female sexual dysfunction (FSD) caused by untreated endocrine disease, e.g.hypopituitarism, hypothyroidism, diabetes mellitus 5.Pregnant or lactating 6.Hypersensitivity to Ashwagandha 7.Chronic or complicated urinary tract or vaginal infections within previous 12 months 8.Pelvic inflammatory disease within previous 12 months 9.Currently active sexually transmitted disease 10.Currently active moderate to severe vaginitis 11.Cervical dysplasia within previous 12 months 12.Significant cervicitis as manifested by mucopurulent discharge from the cervix 13.Significant gynecologic conditions such as uterine fibroids, vulvar vestibulitis, or vaginismus that may (in the investigator’s opinion) interfere with the subject’s ability to comply with study procedures 14.Psychoses and bipolar disorder 15.Use of neuroleptics or lithium within previous 3 months 16.Unwillingness to forego any medications, herbal treatments, or dietary supplements intended to enhance sexual function during the course of the study 17.History of myocardial infarction within previous 6 months 18.History or evidence of significant renal or hepatic disease within previous 6 months 19.Significant central nervous system diseases within the last 6 months, i.e., stroke, spinal cord injury, multiple sclerosis, etc.
- •20.Unwillingness to omit cunnilingus (use by a sex partner of the mouth, lips, and tongue to stimulate the females clitoris or other parts of the vulva or vagina) from sexual activities during the study 21.Unwillingness to avoid post-coital fellatio (act of oral stimulation of the penis by a sexual partner) 22.Any condition which, in the Investigator’s opinion, would interfere with the subject’s ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results.
结局指标
主要结局
Improvement from baseline in the total score and domain scores for Female Sexual Function Index (FSFI)
时间窗: 8 weeks
次要结局
- Improvement in the Female Sexual Distress Scale (FSDS)(8 weeks)
- Improvement in the sexual activity from baseline
- Patients Global Assessment of Response to Therapy (PGART) on a 5-point scale of “Excellent response, Good response, Moderate response, Poor response& Worst response†will be assessed by the patients at the end of therapy(8 weeks)
- Patients Global Assessment of Tolerability to Therapy (PGATT) on a 5-point scale of “Excellent tolerability, Good tolerability, Moderate tolerability, Poor tolerability & Worst tolerability†will be assessed by the patients at the end of therapy(8 weeks)
- Incidence of adverse events, either spontaneously reported by the patient, or noticed by the physician will be recorded during the trial(Day 1, week 4, week 8)
研究者
研究点 (1)
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