Nausea and Vomiting in PregnancyNCT07833371
Effect of Moringa Oleifera, Zingiber Officinale, and Curcuma Xanthorrhiza Extracts for Nausea and Vomiting in First-Trimester Pregnancy
An observational study of Nausea and Vomiting in Pregnancy, run by Maranatha Christian University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Nausea and Vomiting in Pregnancy
- Type of treatment
- Pill or oral medicine
- How many people
- 65 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Sep 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Moringa Oleifera, Zingiber Officinale, and Curcuma Xanthorrhiza Extracts for Nausea and Vomiting in First-Trimester Pregnancy: A Retrospective Cohort Study
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start15 Sep 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maranatha Christian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aloysius Suryawan, MD, PhD., Study director, Maranatha Christian UnievrsityTheresia Monica Rahardjo, MD, PhD., Study chair, Maranatha Christian UniversityChintya Villia Putri, Principal investigator, Maranatha Christian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833371
- Sponsor's protocol ID
- Herbal-NVP-T1-2026
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study uses retrospective medical records containing confidential clinical information, and specific consent for external sharing of individual-level data was not obtained.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moringa Oleifera, Zingiber Officinale, and Curcuma Xanthorrhiza Extracts for Nausea and Vomiting in First-Trimester Pregnancy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07833371
- Acronym / sponsor ID
- Herbal-NVP-T1-2026
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Maranatha Christian UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pregnancy-Unique Quantification of Emesis and Nausea Score From Baseline to Day 3
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study uses retrospective medical records containing confidential clinical information, and specific consent for external sharing of individual-level data was not obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aloysius Suryawan, MD, PhD. study director
Maranatha Christian Unievrsity
Theresia Monica Rahardjo, MD, PhD. study chair
Maranatha Christian University
Chintya Villia Putri principal investigator
Maranatha Christian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nausea and Vomiting in Pregnancy, run by Maranatha Christian University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pregnancy-Unique Quantification of Emesis and Nausea Score From Baseline to Day 3 (time frame: Baseline to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.