The Effect Of Pumpkin Seed Extract Capsules On Nutritional Status and Haemoglobin Level in Pregnant Women.

Anemia During Pregnancy Clinical Trial

Official title:

THE EFFECT OF PUMPKIN SEED EXTRACT CAPSULES (Cucurbita Moschata Durch) ON NUTRITIONAL STATUS AND HAEMOGLOBIN LEVEL IN PREGNANT WOMEN TO PREVENTION STUNTING ; A PROTOCOL OF RANDOMIZED CONTROLLED TRIAL STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657821
• Other study ID #: Indonesia TimurU
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 25, 2022
• Est. completion date: August 25, 2023

Study information

• Verified date: December 2022
• Source: Indonesia Timur University
• Contact: Rosdiana Syakur
• Phone: +6285299856839
• Email: rosdianaary[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this to measure the effect of supplementation of Yellow Pumpkin Seed Extract Capsules in pregnant women on hemoglobin levels and nutritional status of pregnant women.

The main question[s] it aims to answer are:

• is there a difference in changes in nutritional status (increase in body weight and MUAC) in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets

• is there a difference in changes in hemoglobin levels in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets.

The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks

Description:

This study was designed with an experimental method using a randomized double blind with a control group. The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks. The research will be conducted in the village of the stunting locus, Bone Regency, South Sulawesi, Indonesia. Data analysis was carried out with SPSS, where to see the difference between the intervention group and the contro group, a paired t test was used if the data was normally distributed and an alternative test if the data was not normally distributed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 39 Years

Eligibility

Inclusion Criteria:

1. in the one or second trimester of pregnancy;

2. having no complications;

3. willing to participate in this study;

4. domiciled in the stunting locus village Bone regency .

Exclusion Criteria:

• Pregnant women with complications

Related Conditions & MeSH terms

• Anemia During Pregnancy

Intervention

Dietary Supplement:
• Pumpkin seeds extract capsules
the intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks

Locations

Country	Name	City	State
Indonesia	Stunting Locus Village	Bone	South Sulawesi

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Rosdiana Syakur	Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out	12 weeks
Primary	hemoglobin levels	Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.	12 weeks