Nausea GravidarumGDNVPNCT06772974
Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
A study testing Doxylamine Succinate USP and Ginger in people with Nausea Gravidarum and Hyperemesis Gravidarum, run by Nawaz Sharif Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Nausea Gravidarum, Hyperemesis Gravidarum
- What is being tested?
- Doxylamine Succinate USP and Ginger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Aziz Bhatti Shaheed Teaching Hospital
Gujrat, Punjab Province, 50700
Syed Muhammad Ali Shah, MBBS, FCPS, 03336066295, syedmuhammadalishah5@gmail.com
Zunnaira Pervaiz PGR, MBBS, MS Gynae and Obs
About this study
Official title: Comparison of 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.
Read the 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
- Being tested
- Doxylamine Succinate USP, Ginger
- Keywords
- Nausea, Vomiting, Pregnancy
- Medical subject headings
- Hyperemesis Gravidarum, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxylamine Succinate USPDrug
Tab. Doxylamine Succinate
GingerDietary supplement
Ginger (zingiber officinale)
| Study group | Role | What they receive |
|---|---|---|
| Ginger Group | Experimental | Ginger Receives: Dietary Supplement: Ginger |
| Doxylamine Group | Active comparator | Tab. Doxylamine Succinate USP Receives: Drug: Doxylamine Succinate USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 21 Days
Secondary outcomes (1)
Side Effects of Treatment
The secondary outcomes will include the adverse effects like headache, sedation, constipation, heart burning or any other effect that will be reported by patient.
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nausea GravidarumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nawaz Sharif Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gujrat
- Responsible party
- Principal investigator, Zunaira Pervez, Nawaz Sharif Medical College
- Investigators
- Syeda Shaista Waheed Professor, MBBS, FCPS, Study director, Nawaz Sharif Medical College, Gujrat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772974
- Sponsor's protocol ID
- GingerVsDoxylamine
- Other IDs
- NSMC/GYNOBS/14/25, NCT06772974
- Acronym
- GDNVP
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy of patients
Publications
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.
PubMed 31937153
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy
- ClinicalTrials.gov ID
- NCT06772974
- Acronym / sponsor ID
- GDNVP / GingerVsDoxylamine
- Conditions
- Nausea Gravidarum, Hyperemesis Gravidarum
- Keywords
- Nausea, Vomiting, Pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Nawaz Sharif Medical CollegeUniversity, hospital or other
- Collaborators
- University of Gujrat
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger Group | Experimental | Dietary Supplement: GingerGinger |
| Doxylamine Group | Active comparator | Drug: Doxylamine Succinate USPTab. Doxylamine Succinate USP |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxylamine Succinate USPTab. Doxylamine Succinate | Drug | Doxylamine Group |
| GingerGinger (zingiber officinale) | Dietary supplement | Ginger Group |
Primary outcome
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).
1 secondary outcome
Side Effects of Treatment
Time frame: 21 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Background: PubMed 31937153Hu 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.
- Individual participant dataSharing planned: No. Privacy of patients
Related trials for Nausea Gravidarum
Not yet recruitingObservational study
Diagnostic and Psychometric Validation of the FRENCH HELP Scale in Hyperemesis Gravidarum
Hyperemesis Gravidarum, Nausea and Vomiting of Pregnancy
RecruitingPhase 1/2
Hyperemesis Gravidarum Risk Reduction With Metformin
Hyperemesis Gravidarum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syeda Shaista Waheed Professor, MBBS, FCPS study director
Nawaz Sharif Medical College, Gujrat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doxylamine Succinate USP and Ginger in people with Nausea Gravidarum and Hyperemesis Gravidarum, run by Nawaz Sharif Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zunnaira Pervaiz Pervaiz, MBBS (+923364209554, zunairapervaiz.zp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Nausea and Vomiting based on Pregnancy-Unique Quantification of Emesis Score (time frame: 21 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06772974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.