Pilot Trial of Hibiscus Drink During Pregnancy (PTHDDP)

Victor Eduardo Alcantar Rodríguez

Status: Completed

Conditions: Pregnant Woman

Treatments: Dietary Supplement: Hibiscus sabdariffa drink

Study type: Interventional

Funder types: Other

Identifiers

NCT07175597

IPNMexico

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women in the second trimester of pregnancy (14 to 28 gestation weeks)
• Age 18 to 35 years
• Blood pressure <140/90 mmHg

Exclusion criteria

• Multiple or high-risk pregnancy
• Hypertensive disorder in previous pregnancies
• Body mass index >32 kg/m2
• Present chronic diseases

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Pregnant women

Experimental group

Description:

Pregnant women in the second trimester of pregnancy who consumed a daily dose of Hibiscus sabdariffa drink for 4 weeks

Treatment:

Dietary Supplement: Hibiscus sabdariffa drink