About this trial
Nausea and vomiting are common GI symptoms of pregnancy. Multiple managing options have been used for NVP. Doxylamine succinate is used as first line treatment for NVP despite that alternative modalities such as ginger extracts and tablets is being explored.
This RCT will be conducted after taking ethical approval and informed consent, in Department of Gynecology, Aziz Bhatti Shaheed teaching hospital, Gujrat. Patients will be divided into two equal groups. One group will receive tablet ginger while other group will receive Doxylamine succinate tablets. Baseline PUQE score (3- 15 point scale) over 24 hour will be noted according to symptoms of nausea and vomiting following 7 days of treatment and then at 2nd and 3rd week. Comparison of the change in the severity of nausea from baseline scores (Post-therapy PUQE score - base line scores) in both groups will be considered for results.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women age>18 years
5 to 8weeks of gestation and 8+1to11weeks
Attending OPD with signs and symptoms of nausea and vomiting with ultrasound confirmed pregnancy
1st and 2nd gravida
Disqualifiers
Patients were hospitalized for Hyperemesis Gravidarum
Medical disorders like Diabetes Mellitus, Hepatic, Gastric, Pancreatic, Pyelonephritis, Thyroid and Psychological Disorder
Patients not responding to treatment after 1week will be excluded
Patients who will not give consent
Trial design
Parallel
Treatments tested in this trial
Doxylamine Succinate USP
DrugTab. Doxylamine Succinate
Ginger
Dietary supplementGinger (zingiber officinale)
Treatment groups
Trial outcomes
Primary outcomes
Reduction in Nausea and Vomiting based on Pregnancy-Unique Quantification of Emesis Score
improvement in Nausea and reduction in Vomiting based on Pregnancy-Unique Quantification of Emesis score. This score depicts the severity of emesis. Mild 4-6 moderate 7-12 and severe emesis is considered when score is more than 13. The primary efficacy endpoint will be the change from baseline in PUQE score after 21 days (± 1 day).
Secondary outcomes
Side Effects of Treatment
The secondary outcomes will include the adverse effects like headache, sedation, constipation, heart burning or any other effect that will be reported by patient.
Sponsors and contacts
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Nawaz Sharif Medical College
Lead sponsor
University of Gujrat
Collaborator
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