Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sexual function in post-menopausal women
研究概览
简要总结
Objective: To study the effects of Tribulus terrestris on sexuality in postmenopausal women.
详细描述
Sexuality is an integral part of every personality, influence thoughts, feelings, actions, integrations, and therefore the physical and mental health. It is estimated that 43% of women have at least one complaint of sexual problem. Disorders of desire and arousal are among the most common problems found in gynecologic practice. Medicinal plants have been used for therapeutic purposes for thousands of years, and aphrodisiac properties described in several plants. Tribulus terrestris is a plant indigenous to India, recommended in the treatment of infertility, low libido and impotence, and its main active ingredient protodioscin (PTN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women past menopause, with full autonomy, at least one year of amenorrhea and FSH> 30 mIU / mL.
- •Sexually active
- •Partner is stable and without sexual difficulties
- •Carrier sexual abuse (desire, arousal, orgasm and dyspareunia)
排除标准
- •Women on hormone therapy within the preceding 12 months
- •Women without sexual activity
- •With diabetes mellitus
- •Patients with cognitive impairment
- •Patients with hormone-dependent tumor
- •History of psychiatric illness
- •Patients with liver disease
- •Patients with kidney disease
- •Users of drugs with proven to decrease sexual desire
- •Cardivascular disease, renal disease.
研究组 & 干预措施
Placebo
1 tablet of placebo/ oral/ 3 times a day for three months
干预措施: Placebo (Drug)
Tribulus terrestris
1 tablet of 250mg/ oral/ 3 times a day for three months
干预措施: Tribulus terrestris (Drug)
结局指标
主要结局
Sexual function in post-menopausal women
时间窗: 90 days
Based the questionnaires Golombok-Rust Inventory of Sexual Satisfaction (GRISS) and Sexual Quotient - female version (SQF).
次要结局
- Female Intervention Efficacy Index (FIEI)(3 months)
研究者
Sonia Maria Rolim Rosa Lima
Study of the Effects of Tribulus Terrestris on Sexuality in Postmenopausal Women
Faculdade de Ciências Médicas da Santa Casa de São Paulo