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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Other: Date fruit; Drug: Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg; Other: Diet

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • PNS SHIFA Hospital , Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Date fruit; 3 Dates after breakfast	Other: Date fruit; 3 Dates after breakfast; Other Names: Date intake in morning
Active Comparator: Antiemetic medication; Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg	Drug: Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg; Doxylamine succinate 10 mg + Pyridoxine HCl 10 mg , One per day; Other Names: Antiemetic once per day
Active Comparator: Appropriate Diet only; Avoidance of high fat foods and enhanced intake of hydrating fruits and vegetables	Other: Diet; Avoidance of high in fat foods and enhanced intake of hydrating fruits and vegetables; Other Names: Diet as per advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks
Dietary Recall	Direct compliance inquired via telephonic communication on regular basis	12 weeks

Collaborators and Investigators

• Sponsor: Bahria University
• Investigators: Principal Investigator: Shehla M Baqai, MBBS, FCPS, FICS, Bahria University Health Sciences Campus Karachi

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2025
• Primary Completion (Estimated): January 25, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Vomiting; Dates; Hyperemesis gravidarum; Haemoglobin; Morning Sickness of pregnancy
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Signs and Symptoms, Digestive; Pregnancy Complications; Morning Sickness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vomiting; Hyperemesis Gravidarum; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Diet, Food, and Nutrition; Physiological Phenomena; Physical Phenomena; Nutritional Physiological Phenomena; Picolines; Time; Vitamin B 6; Diet; Chronology as Topic; doxylamine succinate
• Other Study ID Numbers: BUHS-IRB#163/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No