The comparison of the effect of bitter orange and ondansetron on treatment of nausea and vomiting of pregnancy

Phase 3

Recruiting

• Conditions: O21.9; ausea & vomiting in pregnancy.; Vomiting of pregnancy, unspecified

• Registration Number: IRCT20140525017827N11
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

gestational age between 6-20 weeks of pregnancy (according to a reliable LMP and ultrasound confirmation of the first trimester)
Having mild to moderate nausea and vomiting without a need of hospitalization
Singleton pregnancy with a live normal fetus
Not having any known gastrointestinal disorder
Without a history of smoking or drug use
Lack of a known mental illness such as severe anxiety and depression
Not having any known allergy or hypersensitivity to herbal medications

Exclusion Criteria

Severe nausea and vomiting needing hospitalization
No acceptance for herbal medicine
Having any other symptoms showing pathologic problems such as diarrhea
Having any known gastrointestinal or any other systemic disorder or any drug use except common supplementation (folic acid)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensity of nausea and vomiting. Timepoint: Before start and two weeks later of treatment. Method of measurement: Visual analog scale.

Secondary Outcome Measures

Name	Time	Method
Quality of life score. Timepoint: Before start and two weeks later of treatment. Method of measurement: Short Form 36 Health Survey (SF-36).