Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorNawaz Sharif Medical College

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Doxylamine Succinate USP

    Drug

    Tab. Doxylamine Succinate

  • Ginger

    Dietary supplement

    Ginger (zingiber officinale)

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Ginger GroupExperimental treatment 1 intervention
Group B: Doxylamine GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
21 Days

Secondary outcomes

1

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.

Time frame
21 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nawaz Sharif Medical College

Lead sponsor

University of Gujrat

Collaborator

This trial is not recruiting at the moment. You can still explore other options: