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

• Sponsor: Dr. Rosdiana Syakur (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05657821
• Collaborator: Hasanuddin University (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Anemia During Pregnancy	Dietary Supplement: Pumpkin seeds extract capsules	Early Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 25, 2022
• Anticipated Primary Completion Date: Jan 25, 2023
• Anticipated Study Completion Date: Aug 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pumpkin seed extract capsules . In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks	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
Placebo Comparator: Iron tablets the control group received iron tablets for 12 weeks	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

Outcome Measures

Primary Outcome Measures

1. Nutritional status [12 weeks]

   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

2. hemoglobin levels [12 weeks]

   Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stunting Locus Village	Bone	South Sulawesi	Indonesia	90000

Sponsors and Collaborators

• Dr. Rosdiana Syakur
• Hasanuddin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Rosdiana Syakur, Indonesia Timur University, Indonesia Timur University
• ClinicalTrials.gov Identifier: NCT05657821
• Other Study ID Numbers: Indonesia TimurU
• First Posted: Dec 20, 2022
• Last Update Posted: Dec 20, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 20, 2022