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

NCT07833371 | Active Not Recruiting

• 1 other identifier: Herbal-NVP-T1-2026
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nausea and Vomiting in Pregnancy

Keywords

Nausea and vomiting of pregnancy; First-trimester pregnancy; Pregnancy-Unique Quantification of Emesis and Nausea; PUQE; Moringa oleifera; Zingiber officinale; Curcuma xanthorrhiza; Ondansetron

Outcome Measures

Primary Outcomes (1)

• Change in Pregnancy-Unique Quantification of Emesis and Nausea Score From 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.

  Baseline to day 3

Study Arms (2)

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.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Medical records of pregnant patients aged 20-40 years with a documented gestational age of 1-12 weeks and nausea and vomiting of pregnancy who received routine clinical treatment with oral ondansetron, either alone or combined with Moringa oleifera, Zingiber officinale, and Curcuma xanthorrhiza extracts. Eligible records must contain complete baseline and day-3 PUQE scores.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maranatha Christian University: lead

Study Sites (1)

Klinik Utama Permata Hati

Bandung, West Java, 40226, Indonesia

Location

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aloysius Suryawan, MD, PhD.

  Maranatha Christian Unievrsity

  STUDY DIRECTOR

• Theresia Monica Rahardjo, MD, PhD.

  Maranatha Christian University

  STUDY CHAIR

• Chintya Villia Putri

  Maranatha Christian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)