CTRI/2015/07/006045招募中4 期
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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Females between 21 to 50 years of age
- •2.Have been previously â??functionalâ?? 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 investigatorâ??s opinion) interfere with the subjectâ??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 Investigatorâ??s opinion, would interfere with the subjectâ??s ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results
研究者
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