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

NCT06772974 | Not Yet Recruiting DMC

• 3 other identifiers: GingerVsDoxylamineNSMC/GYNOBS/14/25NCT06772974
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea Gravidarum; Hyperemesis Gravidarum

Keywords

Nausea; Vomiting; Pregnancy

Outcome Measures

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).

  21 Days

Secondary Outcomes (1)

• Side Effects of Treatment

  21 Days

Study Arms (2)

Ginger Group

EXPERIMENTAL

Ginger

Dietary Supplement: Ginger

Doxylamine Group

ACTIVE COMPARATOR

Tab. Doxylamine Succinate USP

Drug: Doxylamine Succinate USP

Interventions

Doxylamine Succinate USP DRUG

Tab. Doxylamine Succinate

Doxylamine Group

Ginger DIETARY_SUPPLEMENT

Ginger (zingiber officinale)

Ginger Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women age\>18 years
• to 8weeks of gestation and 8+1to11weeks
• Attending OPD with signs and symptoms of nausea and vomiting with ultrasound confirmed pregnancy
• st and 2nd gravida
• Patients who will give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Nawaz Sharif Medical College: lead
• University of Gujrat: collaborator

Study Sites (1)

Aziz Bhatti Shaheed Teaching Hospital

Gujrat, Punjab Province, 50700, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 31937153 BACKGROUND

MeSH Terms

Conditions

Hyperemesis Gravidarum; Nausea; Vomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Syeda Shaista Waheed Professor, MBBS, FCPS

  Nawaz Sharif Medical College, Gujrat

  STUDY DIRECTOR

Central Study Contacts

Zunnaira Pervaiz Pervaiz, MBBS

CONTACT

+923364209554; zunairapervaiz.zp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Gradute Resident

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: January 15, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 15, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)