Other Skin and Subcutaneous InfectionsNCT05084443
Effect of Roselle-based Drink on Blood Pressure and Skin
A study testing Drink in people with Other Skin and Subcutaneous Infections, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Skin and Subcutaneous Infections
- What is being tested?
- Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2017to 19 Oct 2018
- 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 40 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- Subjects should not be under any medication
- Subject must be able to drink
Who cannot join
- Subjects with chronic renal, liver or cardiac disorders, Diabetes, hyperlipidemia.
- Also pregnant women, chain smokers, high alcohol consumers should not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Other Skin and Subcutaneous Infections
- Being tested
- Drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrinkDietary supplement
Also called Roselle Drink (SF-R product of Han Bu)
Roselle and placebo drink for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo/Control | Placebo comparator | Placebo drink-- Orally (200 ml/day) Receives: Dietary Supplement: Drink |
| Roselle Based drink (Test) | Experimental | Roselle-Based Drink--- Orally (200 ml/day) Receives: Dietary Supplement: Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure by sphygmomanometer (mmHg)
Both systolic and diastolic blood pressure were changed after Roselle drink
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start11 Sep 2017
- Primary completion15 Jun 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Skin and Subcutaneous InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Kun Wang, Chung Shan Medical University
- Investigators
- Chin-Kun Wang, Ph.D, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084443
- Sponsor's protocol ID
- CS11102
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Roselle-based Drink on Blood Pressure, Antioxidative Activity and Skin Condition
- ClinicalTrials.gov ID
- NCT05084443
- Acronym / sponsor ID
- CS11102
- Conditions
- Other Skin and Subcutaneous Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 19 Oct 2021 (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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo/Control | Placebo comparator | Dietary Supplement: DrinkPlacebo drink-- Orally (200 ml/day) |
| Roselle Based drink (Test) | Experimental | Dietary Supplement: DrinkRoselle-Based Drink--- Orally (200 ml/day) |
Who may qualify
- Ages
- 40 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adults
- Subjects should not be under any medication
- Subject must be able to drink
Key exclusion criteria (2 listed)
- Subjects with chronic renal, liver or cardiac disorders, Diabetes, hyperlipidemia.
- Also pregnant women, chain smokers, high alcohol consumers should not be included.
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 |
|---|---|---|
| DrinkAlso: Roselle Drink (SF-R product of Han Bu)Roselle and placebo drink for 6 months | Dietary supplement | Placebo/Control, Roselle Based drink (Test) |
Primary outcome
Blood pressure by sphygmomanometer (mmHg)
Time frame: 6 months
Both systolic and diastolic blood pressure were changed after Roselle drink
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 26 Oct 2021.
- Individual participant dataSharing planned: No
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.
Chin-Kun Wang, Ph.D principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drink in people with Other Skin and Subcutaneous Infections, run by Chung Shan Medical University at 1 site in Taiwan.
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 2 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 26 Oct 2021. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Blood pressure by sphygmomanometer (mmHg) (time frame: 6 months). 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 26 Oct 2021.