CTRI/2024/12/078378尚未招募不适用
A Randomized, Double Blind, Placebo Controlled, Parallel-Group Clinical Study to Evaluate the Safety and Efficacy of ShataVida in Improving the Menopausal Symptoms in Healthy Women.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change of perimenopausal and menopausal symptoms by various assessments
研究概览
简要总结
This is a double blind, randomized, placebo controlled, parallel group study. After the informed consent process,the subject will be evaluated for symptoms, medical history and medications. The subjects fulfilling the study inclusion criteria and who do not meet any exclusion criteria will be eligible for the study. Subjects shall be randomly assigned in 1:1 ratio to one of the two treatment groups. Clinical assessments shall include all the measures required for the primary and secondary objectives of the study. The safety assessments shall include monitoring of adverse events (AEs), physical examination, vital signs measurement, Urine Pregnancy Tests (UPT; for females of childbearing potential), hematology and clinical chemistry and urine routine tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •1.Subjects with a BMI of 18.5 to 29.9 kg/m2 2.Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening 3.Subjects with moderate or severe rating according to the modified Kupperman menopausal index severity grading
- •Subjective symptoms of hot flushes 5.Subjects willing and able to give informed consent and comply with the study procedures 6.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period 7.Subjects willing to refrain from taking any medications or preparations for addressing menopause symptoms, stress or anxiety or mood or sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study 8.Subjects willing to refrain from consuming alcohol 24 hours prior to the test days
- •Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to test days
- •Subjects willing to refrain from vigorous physical activity 12 hours prior to test days 11.Subjects willing to provide written consent 12.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.Subject with a medical history of breast cancer, cervical cancer, endometrial cancer, colorectal cancer, or ovarian cancer 2.Subject with untreated or under medication of thyroid disorders 3.Subject with a history or current diagnosis of any major diseases of cardiovascular, gastrointestinal, hepatic, renal, pulmonary, or endocrine systems 4.Subjects with a psychiatric diagnosis including anxiety or depression 5.Subjects with sleep disturbances and/or are taking sleep aid medication 6.Subjects with history of using hormonal therapy for menopause 7.Subjects with uncontrolled diabetes and hypertension 8.Subject with a history or current diagnosis of autoimmune conditions 9.Subjects with HIV positive status
- •Subject with alcohol intake greater than 2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers 11.Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit 12.Clinically significant or abnormal laboratory results during screening 13.Any condition judged by the investigator to be unsuitable for participation in the study 14.Subjects having hypersensitivity or history of allergy to the study product 15.Subjects, who are pregnant, breast feeding or planning to become pregnant during the study period 16.Subjects leading irregular lifestyles 17.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change of perimenopausal and menopausal symptoms by various assessments
时间窗: Screening, Day 28 and Day 56
次要结局
- Overall Safety(Baseline, Day 56)
- Mean change in serum hormone levels(Baseline, Day 56)
研究者
Dr Roopa N K
BGS Global Institute of Medical Sciences
研究点 (1)
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