CTRI/2024/10/074570招募中Unknown
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women. A Randomized, Double-blind, Three arm, Parallel, Placebo-controlled Study
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Mean change in score for Menopause Rating Scale (MRS) from baseline.
研究概览
简要总结
· All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study.
· Subjects will be informed about the purpose of the study and signed informed consent will be taken.
· Blood sampling for efficacy and safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 3 (week 8).
· All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, and visit 3 (week 8) ± 4 days.
The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Menopausal women aged 45 to 65 years 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 menopausal 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.Able to read and write in English or any other vernacular language 7.No plan to commence new treatments over the study period.
- •8.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
排除标准
- •1.Participants taking any form of herbal extract in the last 3 months before study entry.
- •2.Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- •3.Participants with Present active medical, surgical, and gynaecological problems.
- •4.Participants with a history of alcohol, tobacco dependence, or any substance abuse 5.Participants who had undergone bilateral ovariectomy 6.Participants with history of breast or cervical carcinoma 7.Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
- •8.Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult 9.Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study 10.Participants with evidence of uncooperative attitude, including poor compliance.
- •11.Participants with inability to attend follow-up visit 12.Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
- •13.Patients with known hypersensitivity to Ashwagandha.
- •14.Patients who had participated in other clinical trials during the previous 3 months.
- •15.Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
结局指标
主要结局
Mean change in score for Menopause Rating Scale (MRS) from baseline.
时间窗: Mean change in score for Menopause Rating Scale (MRS) from baseline.
次要结局
- Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline.(Baseline, Week 4, Week 8)
- Mean change in Menopause Symptoms Treatment Questionnaire (MENQOL) scores from baseline.(Baseline, Week 4, Week 8)
- Mean change in Profile of Mood States (POMS, abbreviated version) questionnaire scores from baseline.(Baseline, Week 4, Week 8)
- Proportion of women with improvement in Hot Flash (MRS scale) from baseline.(Baseline, Week 4, Week 8)
- Proportion of women with improvement in mood (MRS scale) from baseline. [Time Frame: Baseline, Week Proportion of women with improvement in mood (MRS scale) from baseline.(Baseline, Week 4, Week 8)
- Mean change in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline.(Baseline, Week 8)
- Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.(Baseline, Week 8)
- Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline.(Baseline, Week 8)
- Mean change in Thyroid (T3, T4, TSH) parameters from baseline.(Baseline, Week 8)
- Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.(Baseline, Week 4, Week 8)
- Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks.(Baseline, Week 4, Week 8)
研究者
Dr Ashutosh Ajgaonkar
Trupti hospital
研究点 (1)
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