Anemia During PregnancyEarly Phase 1NCT05657821
The Effect Of Pumpkin Seed Extract Capsules On Nutritional Status and Haemoglobin Level in Pregnant Women.
A Early Phase 1 study testing Pumpkin seeds extract capsules in people with Anemia During Pregnancy, run by Dr. Rosdiana Syakur at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 17 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia During Pregnancy
- What is being tested?
- Pumpkin seeds extract capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Oct 2022to 25 Aug 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 39 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- in the one or second trimester of pregnancy;
- having no complications;
- willing to participate in this study;
- domiciled in the stunting locus village Bone regency .
Who cannot join
- Pregnant women with complications
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Stunting Locus Village
Bone, South Sulawesi, 90000
Fakhri Kahfi, +6285279093174, fakhrialkahfi10@gmail.com
About this study
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
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:
Read more
- 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
Read the 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.
- Conditions
- Anemia During Pregnancy
- Being tested
- Pumpkin seeds extract capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin seeds extract capsulesDietary supplement
the intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| pumpkin seed extract capsules | Experimental | . In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks Receives: Dietary Supplement: Pumpkin seeds extract capsules |
| Iron tablets | Placebo comparator | the control group received iron tablets for 12 weeks Receives: Dietary Supplement: Pumpkin seeds extract capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
hemoglobin levels
Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start25 Oct 2022
- Primary completion25 Jan 2023 (estimated)
- Study completion25 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Rosdiana Syakur
- Sponsor type
- University, hospital or other
- Collaborators
- Hasanuddin University
- Responsible party
- Sponsor-investigator, Dr. Rosdiana Syakur, Indonesia Timur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657821
- Sponsor's protocol ID
- Indonesia TimurU
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other researchers when study is done
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05657821
- Acronym / sponsor ID
- Indonesia TimurU
- Conditions
- Anemia During Pregnancy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dr. Rosdiana SyakurUniversity, hospital or other
- Collaborators
- Hasanuddin University
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 25 Jan 2023 (estimated)
- Study completion
- 25 Aug 2023 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pumpkin seed extract capsules | Experimental | Dietary Supplement: Pumpkin seeds extract capsules. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks |
| Iron tablets | Placebo comparator | Dietary Supplement: Pumpkin seeds extract capsulesthe control group received iron tablets for 12 weeks |
Who may qualify
- Ages
- 17 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- in the one or second trimester of pregnancy;
- having no complications;
- willing to participate in this study;
- domiciled in the stunting locus village Bone regency .
Key exclusion criteria (1 listed)
- Pregnant women with complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pumpkin seeds extract capsulesthe intervention group was given pumpkin seed capsules for 12 weeks, and the intervention group was given iron tablets for 12 weeks | Dietary supplement | Iron tablets, pumpkin seed extract capsules |
Primary outcome
Nutritional status
Time frame: 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
hemoglobin levels
Time frame: 12 weeks
Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers when study is done
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pumpkin seeds extract capsules in people with Anemia During Pregnancy, run by Dr. Rosdiana Syakur at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosdiana Syakur (+6285299856839, rosdianaary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.