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

Study acronym: GDNVP
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 17, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Phase: Phase 4 to Not applicable
    • Primary endpoint revised
    • Study title shortened, about 7 words
    • Study description shortened, about 1 word
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06772974
Lead Sponsor Nawaz Sharif Medical College
Collaborators: University of Gujrat
Conditions
(from sponsor)
Nausea Gravidarum, Hyperemesis Gravidarum
Related terms Hyperemesis Gravidarum, Nausea, Vomiting
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov