Effect of Moringa Oleifera, Zingiber Officinale, and Curcuma Xanthorrhiza Extracts for Nausea and Vomiting in First-Trimester Pregnancy

Overview

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.

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.