Date Fruit Benefits to Treat Morning Sickness in First Trimester of Pregnancy

NCT07354529 — Not applicable, Active not recruiting, 40 participants, Bahria University

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Evaluation of Benefits of Date Fruit in the First Trimester of Pregnancy

Registry	NCT07354529
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Bahria University (Other)
Conditions	Pregnancy
Interventions	Date fruit, Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg, Diet (Other, drug)
Dates	start 2025-06-15, primary completion 2026-01-25 (estimated), completion 2026-02-01 (estimated), first posted 2026-01-21, last updated 2026-01-21
Locations	1 site in Pakistan

-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 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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Date fruit	Active comparator	Other: Date fruit	3 Dates after breakfast
Antiemetic medication	Active comparator	Drug: Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg	Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg
Appropriate Diet only	Active comparator	Other: Diet	Avoidance of high fat foods and enhanced intake of hydrating fruits and vegetables

Date fruit (Other), also known as Date intake in morning: 3 Dates after breakfast
Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg (Drug), also known as Antiemetic once per day: Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg , One per day
Diet (Other), also known as Diet as per advice: Avoidance of high in fat foods and enhanced intake of hydrating fruits and vegetables

+Outcome measures

Primary outcomes

Hemoglobin [12 Weeks]: Complete blood picture (Laboratory diagnostic tests)
Vomiting [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

Secondary outcomes

Fatigue level [12 weeks]: 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
Dietary Recall [12 weeks]: Direct compliance inquired via telephonic communication on regular basis

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* Pregnant females in 18 to 45 year old age group

Exclusion Criteria:

1. Females in 18 to 45 year old age group who are not pregnant.
2. Females less than 18 years old.
3. Females over 45 years.

+Locations (1)

Facility	City	Country	Status
PNS SHIFA Hospital , Karachi	Karachi, Sindh	Pakistan

+Investigators

Shehla M Baqai, MBBS, FCPS, FICS, Principal investigator, Bahria University Health Sciences Campus Karachi

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