Clinical trial NCT05657821: The Effect Of Pumpkin Seed Extract Capsules On Nutritional Status and Haemoglobin Level in Pregnant Women.
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Anemia During Pregnancy
Lead sponsor: Indonesia Timur University
Sponsor class: OTHER
Collaborators: name: Hasanuddin University
First posted: 2022-12-20
Enrollment: 70
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutritional status
timeFrame: 12 weeks
measure: hemoglobin levels
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bone
country: Indonesia
facility: Stunting Locus Village
state: South Sulawesi
Study officials:
References: