Pregnant WomanPTHDDPNCT07175597
Pilot Trial of Hibiscus Drink During Pregnancy (PTHDDP)
A study testing Hibiscus sabdariffa drink in people with Pregnant Woman, run by Victor Eduardo Alcantar Rodríguez at 1 site in Mexico.
Trial summary
The goal of this phase I pilot clinical trial is to evaluate the acceptability, tolerability and effect on blood pressure and biomarkers of Hibiscus sabdariffa drink in pregnant women in the second trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnant Woman
- What is being tested?
- Hibiscus sabdariffa drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- 30 Apr 2024to 30 Jun 2025
- Phase
- Interventional
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women in the second trimester of pregnancy (14 to 28 gestation weeks)
- Age 18 to 35 years
- Blood pressure <140/90 mmHg
Who cannot join
- Multiple or high-risk pregnancy
- Hypertensive disorder in previous pregnancies
- Body mass index >32 kg/m2
- Present chronic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Acceptability, Tolerability and Biochemical Indicators of Hibiscus Sabdariffa L. Drink in Pregnant Women
The goal of this phase I pilot clinical trial is to evaluate the acceptability, tolerability and effect on blood pressure and biomarkers of Hibiscus sabdariffa drink in pregnant women in the second trimester of pregnancy. The main questions it aims to answer are:
Is the drink acceptable to take as a daily dose for a long time? Does drinking the beverage cause negative effects? What is the effect of drink consumption on blood pressure and biomarkers in pregnant women?
Read more
Each participant was their own control with the values measured before consumption of the beverage and after four weeks of consumption.
The participants:
- Took a daily dose of the beverage for 4 weeks
- Once a week for the four weeks, they answered the acceptability and tolerability questionnaires
- Before starting to consume the beverage and after the 4 weeks of consumption, they had their blood pressure measured, and samples taken for biomarker measurements.
- Conditions
- Pregnant Woman
- Being tested
- Hibiscus sabdariffa drink
- Keywords
- Functional foods, Hibiscus sabdariffa drink, Pilot 1 clinical trial, Hypertension, Biomarkers
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hibiscus sabdariffa drinkDietary supplement
A daily dose of Hibiscus sabdariffa drink that provides 9.6 mg of anthocyanins
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | Pregnant women in the second trimester of pregnancy who consumed a daily dose of Hibiscus sabdariffa drink for 4 weeks Receives: Dietary Supplement: Hibiscus sabdariffa drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Hibiscus sabdariffa drink
Beverage acceptability was measured using a sensory evaluation with 7-point hedonic scale of the attributes of odor, color, flavor, mouthfeel, aftertaste, and overall appearance through questionnaires applied once a week for 4 weeks.
The outcome measures are based on a 7-point hedonic scale where every participant can answer in every attribute evaluated:
- I dislike it a lot
- I dislike it moderately
- I dislike it a little
- I neither like it nor dislike it
- I like it a little
- I like it moderately
- I like it a lot
Measured: 4 weeks
Tolerability of Hibiscus sabdariffa Drink
Tolerability was measured by the presence or absence of gastrointestinal symptoms such as nausea, regurgitation, vomiting, constipation, diarrhea, flatulence, and abdominal pain through questionnaires applied once a week for 4 weeks.
The outcome measures for the tolerability assessment were the presence or absence of gastrointestinal symptoms mentioned in the previous paragraph, where participants had the option to respond:
- Symptom absent
- Symptom present but not bothersome
- Symptom present and somewhat bothersome, but does not interfere with daily activities or sleep
- Symptom present and bothersome because it interferes with daily activities or sleep
- Required medical attention
Measured: 4 weeks
Secondary outcomes (6)
Blood pressure
Blood pressure was measured using the Korotkoff auscultation method, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.
The outcome measures were the average of the measurements of the 10 participants expressed as mm/Hg of systolic and diastolic pressure.
Measured: 4 weeks
Biomarkers glucose
Glucose was measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.
The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.
Measured: 4 weeks
Biomarkers cholesterol
Cholesterol was measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.
The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.
Measured: 4 weeks
Biomarkers triglycerides
Triglycerides were measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.
The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.
Measured: 4 weeks
Biomarkers creatinine
Creatinine was measured by taking a blood sample, These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.
The outcome measures were the average of the measurements of the 10 participants expressed as mg/dL.
Measured: 4 weeks
Biomarkers proteinuria
Participants were also asked to provide a urine sample to determine proteinuria.
These measurements were taken before starting to consume the beverage and at the end of the 4-week trial.
The results were presented as the number of positive cases for proteinuria, as well as the average of positive cases expressed as mg/dL.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start30 Apr 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomanStudies 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
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Four-week phase I pilot trial where participants are their own controls with pre- and post-treatment measurements
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victor Eduardo Alcantar Rodríguez
- Sponsor type
- University, hospital or other
- Collaborators
- National Polytechnic Institute, Mexico
- Responsible party
- Sponsor-investigator, Victor Eduardo Alcantar Rodríguez, National Polytechnic Institute, Mexico
- Investigators
- Victor E. Alcantar Rodríguez, PhD Student, Principal investigator, National Polytechnic Institute and Autonomous University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175597
- Sponsor's protocol ID
- IPNMexico
- Acronym
- PTHDDP
- Status last verified
- Sep 2025
- First submitted
- 27 Aug 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A platform will be sought to publish the results databases.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Acceptability, Tolerability and Biochemical Indicators of Hibiscus Sabdariffa L. Drink in Pregnant Women
- ClinicalTrials.gov ID
- NCT07175597
- Acronym / sponsor ID
- PTHDDP / IPNMexico
- Conditions
- Pregnant Woman
- Keywords
- Functional foods, Hibiscus sabdariffa drink, Pilot 1 clinical trial, Hypertension, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Victor Eduardo Alcantar RodríguezUniversity, hospital or other
- Collaborators
- National Polytechnic Institute, Mexico
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Sep 2025 (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 phase I pilot clinical trial is to evaluate the acceptability, tolerability and effect on blood pressure and biomarkers of Hibiscus sabdariffa drink in pregnant women in the second trimester of pregnancy. The main questions it aims to answer are:
Is the drink acceptable to take as a daily dose for a long time? Does drinking the beverage cause negative effects? What is the effect of drink consumption on blood pressure and biomarkers in pregnant women?
Each participant was their own control with the values measured before consumption of the beverage and after four weeks of consumption.
The participants:
- Took a daily dose of the beverage for 4 weeks
- Once a week for the four weeks, they answered the acceptability and tolerability questionnaires
- Before starting to consume the beverage and after the 4 weeks of consumption, they had their blood pressure measured, and samples taken for biomarker measurements.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Four-week phase I pilot trial where participants are their own controls with pre- and post-treatment measurements
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Dietary Supplement: Hibiscus sabdariffa drinkPregnant women in the second trimester of pregnancy who consumed a daily dose of Hibiscus sabdariffa drink for 4 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women in the second trimester of pregnancy (14 to 28 gestation weeks)
- Age 18 to 35 years
- Blood pressure <140/90 mmHg
Key exclusion criteria (4 listed)
- Multiple or high-risk pregnancy
- Hypertensive disorder in previous pregnancies
- Body mass index >32 kg/m2
- Present chronic diseases
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 |
|---|---|---|
| Hibiscus sabdariffa drinkA daily dose of Hibiscus sabdariffa drink that provides 9.6 mg of anthocyanins | Dietary supplement | Pregnant women |
Primary outcome
Acceptability of Hibiscus sabdariffa drink
Time frame: 4 weeks
Beverage acceptability was measured using a sensory evaluation with 7-point hedonic scale of the attributes of odor, color, flavor, mouthfeel, aftertaste, and overall appearance through questionnaires applied once a week for 4 weeks. The outcome measures are based on a 7-point hedonic scale where every participant can answer in every attribute evaluated: 1. I dislike it a lot 2. I dislike it moderately 3. I dislike it a little 4. I neither like it nor dislike it 5. I like it a little 6. I like it moderately 7. I like it a lot
Tolerability of Hibiscus sabdariffa Drink
Time frame: 4 weeks
Tolerability was measured by the presence or absence of gastrointestinal symptoms such as nausea, regurgitation, vomiting, constipation, diarrhea, flatulence, and abdominal pain through questionnaires applied once a week for 4 weeks. The outcome measures for the tolerability assessment were the presence or absence of gastrointestinal symptoms mentioned in the previous paragraph, where participants had the option to respond: 1. Symptom absent 2. Symptom present but not bothersome 3. Symptom present and somewhat bothersome, but does not interfere with daily activities or sleep 4. Symptom present and bothersome because it interferes with daily activities or sleep 5. Required medical attention
6 secondary outcomes
Blood pressure
Time frame: 4 weeks
Biomarkers glucose
Time frame: 4 weeks
Biomarkers cholesterol
Time frame: 4 weeks
Biomarkers triglycerides
Time frame: 4 weeks
Biomarkers creatinine
Time frame: 4 weeks
Biomarkers proteinuria
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. A platform will be sought to publish the results databases.
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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.
Victor E. Alcantar Rodríguez, PhD Student principal investigator
National Polytechnic Institute and Autonomous University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hibiscus sabdariffa drink in people with Pregnant Woman, run by Victor Eduardo Alcantar Rodríguez at 1 site in Mexico.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Sep 2025. 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 Mexico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Hibiscus sabdariffa drink (time frame: 4 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 16 Sep 2025.