NCT05084443

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

September 29, 2021

Last Update Submit

October 19, 2021

Conditions

Other Skin and Subcutaneous Infections

Outcome Measures

Primary Outcomes (1)

  • Blood pressure by sphygmomanometer (mmHg)

    Both systolic and diastolic blood pressure were changed after Roselle drink

    6 months

Study Arms (2)

Placebo/Control

PLACEBO COMPARATOR

Placebo drink-- Orally (200 ml/day)

Dietary Supplement: Drink

Roselle Based drink (Test)

EXPERIMENTAL

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

Dietary Supplement: Drink

Interventions

DrinkDIETARY_SUPPLEMENT

Roselle and placebo drink for 6 months

Also known as: Roselle Drink (SF-R product of Han Bu)
Placebo/ControlRoselle Based drink (Test)

Eligibility Criteria

Age40 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University

Taichung, Taichung, 40201, Taiwan

Location

Study Officials

  • Chin-Kun Wang, Ph.D

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 19, 2021

Study Start

September 11, 2017

Primary Completion

June 15, 2018

Study Completion

October 19, 2018

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)