Evaluation of Efficacy and Safety of extract of Ashwagandha (Withania somnifera) Standardized Extract in Women with Perimenopausal Symptoms: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Composite score of Menopause Rating Scale (MRS)
研究概览
简要总结
This prospective, randomized, double-blind, placebo-controlled study shall compare the efficacy and safety of extract of KSM66 Ashwagandha (Withania somnifera) with placebo in improving perimenopausal symptoms in women.
Perimenopausal women aged 45 to 60 years of age having a BMI of 18-35 kg/m2, with intact uterus and ovaries who complain of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days wil be screened for enrollment. Women should have miss at least 2 cycles during the past 12 months, or reported menopause for at least 60 days. Women may have complaints of perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc. Those not willing to participate and not literate shall be exclude
Women will be randomized to receive either ashwagandha extract capsule 300 mg two times daily or placebo capsule (identical to ashwagandha capsule) two times daily for 8 weeks.
Assessments shall be done using the Menopause Rating Scale (MRS), Menopause Specific Quality of Life (MEN-QOL) questionnaire, menstrual cycle patterns, symptoms, waist circumference, blood pressure, serum hormones (FSH, LH, testesterone, estradiol) and clinical adverse events over a period of 8 weeks (follow-up visits 4 & 8 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Perimenopausal women with intact uterus and ovaries 2.Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days.
- •At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days 3.Females with complaints of perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
- •4.Body mass index 18-35 kg/m2 5.Subject who has given written informed consent to participate in the study and understand the nature of the study 6.Not illiterate.
排除标准
- •1.Taking any form of herbal extract in the last 3 months before study entry 2.On hormone replacement therapy for more than 3 months 3.Present active medical, surgical and gynecological problems 4.History of drug or alcohol abuse 5.Ovariectomy 6.History of breast or cervical carcinoma 7.Taking medication that affect bone metabolism, including glucocorticoids, anticonvulsant and methotrexate 8.Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult 9.Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 10.Evidence of uncooperative attitude, including poor compliance 11.Inability to attend follow-up visit 12.Subject with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
结局指标
主要结局
Composite score of Menopause Rating Scale (MRS)
时间窗: Baseline, 4 weeks, 8 weeks
次要结局
- Composite score of Menopause Specific Quality of Life (MEN-QOL) questionnaire(Baseline, 4 weeks, 8 weeks)
- Hot flash score(Baseline, 4 weeks, 8 weeks)
- Blood pressure (systolic and diastolic)(Baseline, 4 weeks, 8 weeks)
- Menstrual Pain(Baseline, 4 weeks, 8 weeks)
- Menstrual cycle(Baseline, 8 weeks)
- Waist circumference(Baseline, 4 weeks, 8 weeks)
- Serum hormone levels (FSH, LH, Estradiol, Testesterone)(Baseline, 4 weeks, 8 weeks)
- Global Assessment of Tolerability to Therapy (PGATT)(End of therapy (8 weeks))
- CLinical adverse events(Baseline, 4 weeks, 8 weeks)