ACTRN12622001341718尚未招募未知
The Effects of Eurycoma Longifolia Water Extract (Physta®) on Well-Being of Peri and Postmenopausal Women: A Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 45 Years 至 55 Years（—）
- 性别
- Female
入选标准
- •a)Women aged 45-55 years
- •b)Scoring of MENQOL is more than or equal to 61 (higher score indicates the presence of climacteric symptoms)
- •c)Experience aches at muscles, joints, back of the neck and head (Scores YES” for MENQOL question number 12 or/and 15)
- •d)Experience tiredness, worn out and lack of energy (Score YES” for MENQOL question number 13 or/and 18)
- •e)In a stable heterosexual relationship for at least 6 months
- •f)BMI 20-29.9 kg/m2
排除标准
- •a)Uncontrolled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg)
- •b)Familial and past medical history or current diagnosis of breast cancer or breast cancer in an identical twin, or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to randomization. Subjects with other cancers in full remission more than 5 years after diagnosis are acceptable with the exceptions of breast cancer or genital organ cancer (e.g., cervical cancer, uterine cancer, endometrial cancer, colorectal cancer or ovarian cancer)
- •c)Uncontrolled diabetes which include fasting blood sugar of > 10 mM/L
- •d)Uncontrolled and/or untreated thyroid disorder
- •e)History or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
- •f)History or current diagnosis of autoimmune conditions, immunodeficiency, rheumatoid-arthritis or gynecological disease
- •g)Clinically significant mental depression that is not well-controlled in the opinion of the investigator
- •h)Subject has undergone major surgery within the past one year prior to the randomization visit, except cholecystectomy, and appendectomy
- •i)Subject smokes more than 15 cigarettes a day
- •j)History of alcohol or drug abuse within the past year
- •k)Subjects with known allergic reactions to Tongkat Ali or any other herbal supplements
- •l)Women already on hormonal therapy for menopause
- •m)Women with uninvestigated abnormal uterine bleeding.
- •n)Women with thickened endometrium on ultrasound (i.e. >5mm (in postmenopausal) and >11mm (premenopausal)).
研究者
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