Effect of Roselle-based Drink on Blood Pressure and Skin

Effect of Roselle-based Drink on Blood Pressure, Antioxidative Activity and Skin Condition

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.

Study Overview

• Status: Completed
• Conditions: Other Skin and Subcutaneous Infections
• Intervention / Treatment: Dietary supplement: Drink

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung
    • Taichung city, Taichung, Taiwan, 40201
      • Chung Shan Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo/Control; Placebo drink-- Orally (200 ml/day)	Dietary supplement: Drink; Roselle and placebo drink for 6 months; Other Names: Roselle Drink (SF-R product of Han Bu)
Experimental: Roselle Based drink (Test); Roselle-Based Drink--- Orally (200 ml/day)	Dietary supplement: Drink; Roselle and placebo drink for 6 months; Other Names: Roselle Drink (SF-R product of Han Bu)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure by sphygmomanometer (mmHg)	Both systolic and diastolic blood pressure were changed after Roselle drink	6 months

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Principal Investigator: Chin-Kun Wang, Ph.D, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CS11102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No