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

NCT ID: NCT06772974

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2025-07-15

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.

Conditions

Nausea Gravidarum; Hyperemesis Gravidarum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ginger Group

Ginger

Group Type: EXPERIMENTAL

Ginger

Intervention Type: DIETARY_SUPPLEMENT

Ginger (zingiber officinale)

Doxylamine Group

Tab. Doxylamine Succinate USP

Group Type: ACTIVE_COMPARATOR

Doxylamine Succinate USP

Intervention Type: DRUG

Tab. Doxylamine Succinate

Interventions

Doxylamine Succinate USP

Tab. Doxylamine Succinate

Intervention Type: DRUG

Ginger

Ginger (zingiber officinale)

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Gujrat

OTHER

Sponsor Role: collaborator

Nawaz Sharif Medical College

OTHER

Sponsor Role: lead

Responsible Party

Zunaira Pervez

Post Gradute Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Syeda Shaista Waheed Professor, MBBS, FCPS

Role: STUDY_DIRECTOR

Nawaz Sharif Medical College, Gujrat

Locations

Aziz Bhatti Shaheed Teaching Hospital

Gujrat, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Zunnaira Pervaiz Pervaiz, MBBS

Role: CONTACT

zunairapervaiz.zp@gmail.com

+923364209554

Facility Contacts

Syed Muhammad Ali Shah, MBBS, FCPS

Role: primary

syedmuhammadalishah5@gmail.com

03336066295

References

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.

Reference Type: BACKGROUND

PMID: 31937153 (View on PubMed)

Other Identifiers

NSMC/GYNOBS/14/25

Identifier Type: OTHER

Identifier Source: secondary_id

NCT06772974

Identifier Type: REGISTRY

Identifier Source: secondary_id

GingerVsDoxylamine

Identifier Type: -

Identifier Source: org_study_id