Effect of Moringa Oleifera, Zingiber Officinale, and Curcuma Xanthorrhiza Extracts for Nausea and Vomiting in First-Trimester Pregnancy: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Change in Pregnancy-Unique Quantification of Emesis and Nausea Score From Baseline to Day 3
研究概览
简要总结
This retrospective cohort study will evaluate the association between adjunctive Moringa oleifera, Zingiber officinale, and Curcuma xanthorrhiza extracts and changes in Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) scores among patients with nausea and vomiting of pregnancy during the first trimester.
Eligible medical records will be classified into two groups according to the treatment previously received as part of routine clinical care. The adjunctive group received ondansetron together with a fixed-dose herbal extract combination, whereas the control group received ondansetron without the herbal combination.
The primary outcome will be the change in PUQE score from baseline to day 3. The study will also compare the proportion of patients achieving a clinically relevant reduction in PUQE score between the two groups.
详细描述
Nausea and vomiting of pregnancy are common during the first trimester and may adversely affect nutritional intake, daily functioning, and quality of life. Ginger has been widely investigated for pregnancy-related nausea, while Moringa oleifera and Curcuma xanthorrhiza contain bioactive compounds with potential nutritional, antioxidant, anti-inflammatory, and gastrointestinal effects. Evidence regarding the use of these three extracts as an adjunct to standard antiemetic therapy during pregnancy remains limited.
This single-center retrospective comparative cohort study will review consecutive medical records of patients with nausea and vomiting of pregnancy at 1 to 12 weeks of gestation. Treatment exposure will be determined from therapies previously provided during routine clinical care. No treatment will be assigned by the investigators for the purpose of this study.
Both groups received oral ondansetron 4 mg twice daily for 3 days. The adjunctive group also received one capsule twice daily of a fixed-dose herbal product containing Moringa oleifera leaf extract 250 mg, Zingiber officinale extract 250 mg, and Curcuma xanthorrhiza extract 50 mg per capsule. The control group received ondansetron without the adjunctive herbal product.
Nausea and vomiting severity was assessed using the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score before treatment and on day 3. The primary outcome will be the change in PUQE score from baseline to day 3. Secondary analyses will assess changes within each group, differences in day-3 PUQE scores after accounting for baseline PUQE, and the proportion of patients achieving a reduction of at least 2 PUQE points.
Approximately 65 eligible records are expected to be included. Baseline characteristics, including maternal age, gestational age, and baseline PUQE score, will be compared between the groups. Nonparametric paired and between-group analyses will be supplemented by a baseline-adjusted regression model. Findings will be interpreted as associations because treatment exposure was not randomized and residual confounding may remain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients aged 20 to 40 years.
- •Gestational age of 1 to 12 weeks documented in the medical record.
- •Nausea and vomiting of pregnancy.
- •Received oral ondansetron 4 mg twice daily for 3 days, either alone or with adjunctive Moringa oleifera, Zingiber officinale, and Curcuma xanthorrhiza extracts, as part of routine clinical care.
- •Complete PUQE scores available at baseline and day 3.
排除标准
- •Gestational age greater than 12 weeks or gestational age not clearly documented.
- •Not pregnant at the time of treatment.
- •Nausea or vomiting documented as being attributable to a cause other than pregnancy.
- •Duplicate medical records.
- •Missing or incomplete baseline or day-3 PUQE data.
- •Treatment exposure that cannot be clearly classified into either study group.
研究组 & 干预措施
Ondansetron with Herbal Extracts
Pregnant patients with nausea and vomiting of pregnancy who previously received oral ondansetron 4 mg twice daily for 3 days together with one herbal extract capsule twice daily, administered approximately 1 hour after ondansetron. Each herbal capsule contained Moringa oleifera leaf extract 250 mg, Zingiber officinale extract 250 mg, and Curcuma xanthorrhiza extract 50 mg. Treatment was provided as part of routine clinical care and was not assigned by the investigators.
Ondansetron Alone
Pregnant patients with nausea and vomiting of pregnancy who previously received oral ondansetron 4 mg twice daily for 3 days without the herbal extract combination. Treatment was provided as part of routine clinical care and was not assigned by the investigators.
结局指标
主要结局
Change in Pregnancy-Unique Quantification of Emesis and Nausea Score From Baseline to Day 3
时间窗: Baseline to day 3
Nausea and vomiting severity will be assessed using the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score. The total PUQE score ranges from 3 to 15, with higher scores indicating greater symptom severity. Improvement will be calculated as the baseline PUQE score minus the day-3 PUQE score; therefore, a positive value indicates symptom improvement and a larger positive value indicates a greater reduction in symptom severity.
次要结局
未报告次要终点