MedDataX Logo

Effect of Roselle-based Drink on Blood Pressure and Skin

NCT ID: NCT05084443

Last Updated: 2021-10-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-11

Study Completion Date

2018-10-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized, placebo-controlled, double-blind, and cross-over study was designed to check whether the roselle-based drink (2 bottles every day) can alter blood pressure and skin condition in elderly healthy subjects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The subjects were assigned into two groups (control group and test group), each group subject was requested to drink 2 bottles every day (100 mL/bottle, one in the morning and another in the evening), the rate of drinking is 75.42%. There are 39 subjects (25 females and 14 males) completely involved in the thirteen-month trial (cross-over). Blood samples were collected at the initial, 3rd, 6th, 7th, 10th, 13th months of the trial. Skin examinations were performed at the initial, 6th, 7th, 13th months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Other Skin and Subcutaneous Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo/Control

Placebo drink-- Orally (200 ml/day)

Group Type PLACEBO_COMPARATOR

Drink

Intervention Type DIETARY_SUPPLEMENT

Roselle and placebo drink for 6 months

Roselle Based drink (Test)

Roselle-Based Drink--- Orally (200 ml/day)

Group Type EXPERIMENTAL

Drink

Intervention Type DIETARY_SUPPLEMENT

Roselle and placebo drink for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drink

Roselle and placebo drink for 6 months

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Roselle Drink (SF-R product of Han Bu)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy adults
* Subjects should not be under any medication
* Subject must be able to drink

Exclusion Criteria

* Subjects with chronic renal, liver or cardiac disorders, Diabetes, hyperlipidemia.
* Also pregnant women, chain smokers, high alcohol consumers should not be included.
Minimum Eligible Age

40 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chin Kun Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chin-Kun Wang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chung Shan Medical University

Taichung, Taichung, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CS11102

Identifier Type: -

Identifier Source: org_study_id