Clinical trial NCT06772974: Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
Official title: Comparison of Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nausea Gravidarum
Hyperemesis Gravidarum
Keywords: Nausea
Vomiting
Pregnancy
Lead sponsor: Nawaz Sharif Medical College
Sponsor class: OTHER
Collaborators: name: University of Gujrat
First posted: 2025-01-14
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Nausea and Vomiting based on Pregnancy-Unique Quantification of Emesis Score
timeFrame: 21 Days
Secondary outcomes:
measure: Side Effects of Treatment
timeFrame: 21 Days
Other outcomes:
Locations:
city: Gujrat
country: Pakistan
facility: Aziz Bhatti Shaheed Teaching Hospital
state: Punjab
Study officials:
affiliation: Nawaz Sharif Medical College, Gujrat
name: Syeda Shaista Waheed Professor, MBBS, FCPS
role: STUDY_DIRECTOR
References:
citation: Hu Y, Amoah AN, Zhang H, Fu R, Qiu Y, Cao Y, Sun Y, Chen H, Liu Y, Lyu Q. Effect of ginger in the treatment of nausea and vomiting compared with vitamin B6 and placebo during pregnancy: a meta-analysis. J Matern Fetal Neonatal Med. 2022 Jan;35(1):187-196. doi: 10.1080/14767058.2020.1712714. Epub 2020 Jan 14.