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

NCT ID: NCT05657821

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2023-08-25

Brief Summary

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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

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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.

Conditions

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Anemia During Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pumpkin seed extract capsules

. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks

Group Type EXPERIMENTAL

Pumpkin seeds extract capsules

Intervention Type DIETARY_SUPPLEMENT

the intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks

Iron tablets

the control group received iron tablets for 12 weeks

Group Type PLACEBO_COMPARATOR

Pumpkin seeds extract capsules

Intervention Type DIETARY_SUPPLEMENT

the intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hasanuddin University

OTHER

Sponsor Role collaborator

Dr. Rosdiana Syakur

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rosdiana Syakur

Indonesia Timur University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Stunting Locus Village

Bone, South Sulawesi, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Rosdiana Syakur

Role: CONTACT

Phone: +6285299856839

Email: [email protected]

Facility Contacts

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Fakhri Kahfi

Role: primary

Other Identifiers

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Indonesia TimurU

Identifier Type: -

Identifier Source: org_study_id