Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Pregnant Women: A Prospective, Randomized, Comparative 12-week Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hemoglobin,RBC indices (red blood cell count (RBC), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and red cell distribution width (RDW).
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 safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 4 (week 12).
Blood sampling for efficacy parameters will be done from visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) to visit 4 (week 12).
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, visit 3 (week 8) ± 4 days and visit 4 (week 12) ± 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
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women aged between 18 and 35 years.
- •2.Pregnant women 12 to 24 weeks (second trimester) of pregnancy with a normal pregnancy status, without significant comorbid conditions.
- •3.Willing and able to follow the study protocol, including attending regular follow-up visits.
- •4.Provide written informed consent after understanding the study’s risks, benefits, and protocol details.
排除标准
- 未提供
结局指标
主要结局
Hemoglobin,RBC indices (red blood cell count (RBC), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and red cell distribution width (RDW).
时间窗: Baseline, Week 4, Week 8, Week 12
次要结局
- The clinical adverse events, either spontaneously reported by the patient, or noticed by the physician will be recorded during the therapy.(Baseline, Week 4, Week 8, Week 12)
- Laboratory adverse events based on hepatic function tests (serum bilirubin, serum proteins, transaminases, alkaline phosphatase) and renal function tests (serum creatinine, BUN).(Baseline, Week 12)
- Maternal stress assessed using the Perceived Stress Scale [PSS-10].(Baseline, Week 4, Week 8, Week 12)
- Maternal sleep quality assessed using the Pittsburgh Sleep Quality Index [PSQI].(Baseline, Week 12)
研究者
Dr Ashutosh Ajgaonkar
Trupti Hospital