PregnancyNCT07354529
Date Fruit Benefits to Treat Morning Sickness in First Trimester of Pregnancy
A study testing Date fruit, Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg and Diet in people with Pregnancy, run by Bahria University at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating morning sickness of pregnancy in pregnant females. The main question[s] it aims to answer [is/are]: The goal of this randomized clinical trial is to evaluate role of date fruit in The goal of this randomized clinical trial is… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Date fruit, Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg and Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2025to 1 Feb 2026
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant females in 18 to 45 year old age group
Who cannot join
- Females in 18 to 45 year old age group who are not pregnant.
- Females less than 18 years old.
- Females over 45 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Benefits of Date Fruit in the First Trimester of Pregnancy
The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating morning sickness of pregnancy in pregnant females. The main question[s] it aims to answer [is/are]:
The goal of this randomized clinical trial is to evaluate role of date fruit in
Read more
The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating vomiting due to morning sickness of pregnancy and in improving maternal hemoglobin in pregnant females. The main question[s] it aims to answer [are]:
- Role of date fruit in alleviating severity and frequency of vomiting due to morning sickness of pregnancy in pregnant females.
- Role of date fruit in improving haemoglobin levels in pregnant females.
- To assess improvement of severity and frequency of vomiting due to morning sickness of pregnancy and improvement of hemoglobin levels in pregnant females, researchers will compare date fruit intake with antiemetic medication doxylamine succinate 10 mg + pyridoxine HCl 10 and diet only.
Read the detailed description
A randomized Controlled trial to assess benefits of date fruit in morning sickness of pregnancy symptoms, inclusive of nausea and vomiting and to improve haemoglobin levels in pregnant females.
- Conditions
- Pregnancy
- Being tested
- Date fruit, Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg, Diet
- Keywords
- Pregnancy, Dates, Vomiting, Haemoglobin, Morning Sickness of pregnancy, Hyperemesis gravidarum
- Medical subject headings
- Vomiting, Hyperemesis Gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date fruitOther
Also called Date intake in morning
3 Dates after breakfast
Doxylamine succinate 10 mg + Pyridoxine HCl 10 mgDrug
Also called Antiemetic once per day
Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg , One per day
DietOther
Also called Diet as per advice
Avoidance of high in fat foods and enhanced intake of hydrating fruits and vegetables
| Study group | Role | What they receive |
|---|---|---|
| Date fruit | Active comparator | 3 Dates after breakfast Receives: Other: Date fruit |
| Antiemetic medication | Active comparator | Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg Receives: Drug: Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg |
| Appropriate Diet only | Active comparator | Avoidance of high fat foods and enhanced intake of hydrating fruits and vegetables Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Complete blood picture (Laboratory diagnostic tests)
Measured: 12 Weeks
Vomiting
PUQE-24 Score Unabbreviated scale title : The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) Minimum Value : 4-6 (Mild) Maximum Value : ≥13 (Severe) Higher Scores mean worst outcome
Measured: 12 Weeks
Secondary outcomes (2)
Fatigue level
FAS Unabbreviated scale title: Fatigue Assessment Scale (FAS)
Minimum Value : Less less than 22 Maximum Value : 35 or more indicates severe fatigue Higher Scores mean worst outcome
Measured: 12 weeks
Dietary Recall
Direct compliance inquired via telephonic communication on regular basis
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jun 2025
- Primary completion25 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Major Gen (R) Prof Dr Shehla M Baqai, Bahria University
- Investigators
- Shehla M Baqai, MBBS, FCPS, FICS, Principal investigator, Bahria University Health Sciences Campus Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354529
- Sponsor's protocol ID
- BUHS-IRB#163/25
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Benefits of Date Fruit in the First Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT07354529
- Acronym / sponsor ID
- BUHS-IRB#163/25
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Dates, Vomiting, Haemoglobin, Morning Sickness of pregnancy, Hyperemesis gravidarum
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 25 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating morning sickness of pregnancy in pregnant females. The main question[s] it aims to answer [is/are]:
The goal of this randomized clinical trial is to evaluate role of date fruit in
The goal of this randomized clinical trial is to evaluate role of date fruit in alleviating vomiting due to morning sickness of pregnancy and in improving maternal hemoglobin in pregnant females. The main question[s] it aims to answer [are]:
- Role of date fruit in alleviating severity and frequency of vomiting due to morning sickness of pregnancy in pregnant females.
- Role of date fruit in improving haemoglobin levels in pregnant females.
- To assess improvement of severity and frequency of vomiting due to morning sickness of pregnancy and improvement of hemoglobin levels in pregnant females, researchers will compare date fruit intake with antiemetic medication doxylamine succinate 10 mg + pyridoxine HCl 10 and diet only.
Detailed description
A randomized Controlled trial to assess benefits of date fruit in morning sickness of pregnancy symptoms, inclusive of nausea and vomiting and to improve haemoglobin levels in pregnant females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Date fruit | Active comparator | Other: Date fruit3 Dates after breakfast |
| Antiemetic medication | Active comparator | Drug: Doxylamine succinate 10 mg + Pyridoxine HCl 10 mgDoxylamine succinate 10 mg + Pyridoxine HCl 10 mg |
| Appropriate Diet only | Active comparator | Other: DietAvoidance of high fat foods and enhanced intake of hydrating fruits and vegetables |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant females in 18 to 45 year old age group
Key exclusion criteria (3 listed)
- Females in 18 to 45 year old age group who are not pregnant.
- Females less than 18 years old.
- Females over 45 years.
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 |
|---|---|---|
| Date fruitAlso: Date intake in morning3 Dates after breakfast | Other | Date fruit |
| Doxylamine succinate 10 mg + Pyridoxine HCl 10 mgAlso: Antiemetic once per dayDoxylamine succinate 10 mg + Pyridoxine HCl 10 mg , One per day | Drug | Antiemetic medication |
| DietAlso: Diet as per adviceAvoidance of high in fat foods and enhanced intake of hydrating fruits and vegetables | Other | Appropriate Diet only |
Primary outcome
Hemoglobin
Time frame: 12 Weeks
Complete blood picture (Laboratory diagnostic tests)
Vomiting
Time frame: 12 Weeks
PUQE-24 Score Unabbreviated scale title : The Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) Minimum Value : 4-6 (Mild) Maximum Value : ≥13 (Severe) Higher Scores mean worst outcome
2 secondary outcomes
Fatigue level
Time frame: 12 weeks
Dietary Recall
Time frame: 12 weeks
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 21 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shehla M Baqai, MBBS, FCPS, FICS principal investigator
Bahria University Health Sciences Campus Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Date fruit, Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg and Diet in people with Pregnancy, run by Bahria University 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.