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The effect of 5 foods containing antiemetic food extract on the improvement of nausea and vomiting of pregnancy: a randomized study

The effect of 5 foods containing antiemetic food extract on the improvement of nausea and vomiting of pregnancy: a randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067586
Enrollment
Unknown
Registered
2023-01-12
Start date
2023-02-23
Completion date
Unknown
Last updated
2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Interventions

First group:First snack
Second group:Second snack
Third group:Third snack
Fourth group:Fourth snack
Fifth group:Fifth snack
Placebo group:Placebo
Active comparator :Vitamin B6

Sponsors

West China Fourth Hospital and West China School of Public Health, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnant women aged 18-40; 2. The gestational age is less than 14W; 3. PUQE assessed as moderate and above (score greater than 6) pregnant women with nausea and vomiting during pregnancy. 4. Those who signed the informed consent form and voluntarily participated in the study.

Exclusion criteria

Exclusion criteria: 1. Pregnant women with cognitive dysfunction or mental illness that prevent them from understanding the study; 2. Have malignant tumors, acute or subacute severe hepatitis, severe aplastic anemia, idiopathic thrombocytopenic purpura, acute appendicitis, acute pancreatitis, TORCH syndrome and other major diseases; 3. Suffering from chronic diseases, such as poor control of diabetes, coronary heart disease, poor control of hypertension, etc; 4. Have acute or chronic gastrointestinal disease; 5. Nausea and vomiting symptoms already present before pregnancy; 6. The presence of other diseases that cause nausea and vomiting symptoms, such as molar pregnancy; 7. Pregnant women with severe complications during pregnancy, such as severe vomiting; 8. Food or lifestyle modifications have been used to improve nausea and vomiting during pregnancy; 9. Pregnant women who have recently taken vitamin B6, ondansetron, prednisone, traditional Chinese medicine, or acupuncture to improve nausea and vomiting during pregnancy; 10. Pregnant women who have been hospitalized due to nausea and vomiting during severe pregnancy; 11. Pregnant women who are allergic to the active ingredient of interventional foods.

Design outcomes

Primary

MeasureTime frame
Pregnancy-Unique Quantification of Emesis (PUQE);Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score;Rate of admission from baseline to 20 weeks' gestation;Rate of hyperemesis gravidarum from baseline to 20 weeks' gestation;

Secondary

MeasureTime frame
Weight change from baseline to 20 weeks' gestation;HRV (Heart rate variablity) at the fourth day from baseline;Tolerance to interventional foods;

Countries

China

Contacts

Public ContactRuyue Cheng

West China Fourth Hospital and West China School of Public Health, Sichuan University

ruyuecheng1993@163.com+86 28 6836 0940

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026