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NCT Number: NCT06772974

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

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.

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Key information

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aziz Bhatti Shaheed Teaching Hospital

Gujrat, Punjab Province, 50700, Pakistan

Location contact

Syed Muhammad Ali Shah, MBBS, FCPS

CONTACT

[email protected]

03336066295

Zunnaira Pervaiz PGR, MBBS, MS Gynae and Obs

PRINCIPAL_INVESTIGATOR

About this study

Nausea and vomiting are the most common gastrointestinal symptoms of pregnancy. Several treatments have been used for managing NVP. Multiple medications have been used in treatment of NVP. Doxylamine plus pyridoxine is used as first line therapy for NVP. However treatment with alternative medications including ginger extracts and tablets is being explored.

This randomized control trial will be conducted after taking ethical approval and informed consent, in Department of Gynecology, Aziz Bhatti Shaheed teaching hospital, Gujrat. Total 66pregnant females will be enrolled. Demographical data will be recorded. Patients will be divided into two groups (n= 33 in each group). Group A will receive tablet ginger (Zingiber officinale 250mg orally four times daily for 21 days). Group B will receive Doxylamine succinate tablets (10 mg orally, three times daily for 21 days). 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.

Data will be analyzed via SPSS version 25.0. Independent t test and Chi-square test will be used for comparison of the variables between the groups. A paired t test will be used to assess the mean difference in PUQE score within each group (baseline to follow-up). A p-value ≤ 0.05 will be considered as significant. This study aims to compare the efficacy of these two interventions in controlling or reducing the NVP in pregnant women particularly in our local population and will also explore whether ginger or Doxylamine succinate is better in terms of safety. The study will have both theoretical and practical implications provides evidence based clinical data regarding effective NVP treatment in our local population. However, the study will be limited to single center and small sample size.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Patients who will give consent

Exclusion criteria

  • 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

Treatment and study plan

Doxylamine Succinate USP

Drug

Tab. Doxylamine Succinate

Ginger

Dietary Supplement

Ginger (zingiber officinale)

Primary outcomes

  1. Reduction in Nausea and Vomiting based on Pregnancy-Unique Quantification of Emesis Score

    Time frame: 21 Days

    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

  1. Side Effects of Treatment

    Time frame: 21 Days

    The secondary outcomes will include the adverse effects like headache, sedation, constipation, heart burning or any other effect that will be reported by patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Zunnaira Pervaiz Pervaiz, MBBS

CONTACT

[email protected]

+923364209554

Sponsors and collaborators

Lead sponsor

Nawaz Sharif Medical College

Other

Collaborators

  • University of Gujrat

Registry information

Official study title

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

Acronym: GDNVP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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