NCT07354529

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

December 18, 2025

Last Update Submit

January 15, 2026

Conditions

Pregnancy

Keywords

PregnancyDatesVomitingHaemoglobinMorning Sickness of pregnancyHyperemesis gravidarum

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin

    Complete blood picture (Laboratory diagnostic tests)

    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

    12 Weeks

Secondary Outcomes (2)

  • Fatigue level

    12 weeks

  • Dietary Recall

    12 weeks

Study Arms (3)

Date fruit

ACTIVE COMPARATOR

3 Dates after breakfast

Other: Date fruit

Antiemetic medication

ACTIVE COMPARATOR

Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg

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

Other: Diet

Interventions

Date fruitOTHER

3 Dates after breakfast

Also known as: Date intake in morning
Date fruit
Doxylamine succinate 10 mg + Pyridoxine HCl 10 mgDRUG

Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg , One per day

Also known as: Antiemetic once per day
Antiemetic medication
DietOTHER

Avoidance of high in fat foods and enhanced intake of hydrating fruits and vegetables

Also known as: Diet as per advice
Appropriate Diet only

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales only
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant females in 18 to 45 year old age group

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PNS SHIFA Hospital , Karachi

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

VomitingHyperemesis Gravidarum

Interventions

Chronology as Topicdoxylamine succinateVitamin B 6Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMorning SicknessPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

TimePhysical PhenomenaPicolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Shehla M Baqai, MBBS, FCPS, FICS

    Bahria University Health Sciences Campus Karachi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Bahria University Medical College (BUMC) , Bahria University Health Sciences Campus Karachi

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 21, 2026

Study Start

June 15, 2025

Primary Completion

January 25, 2026

Study Completion

February 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)