- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02634242
Study on the Antiaging Effect of Chinese Herb Drink
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Si-Wu-Tang (SWT) is a well-known traditional Chinese medicine (TCM) and widely used for treating various gynecological disorders. The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.
Methods: Sixty healthy voluntary subjects were recruited and assigned into two groups, who drank 125 mL of placebo (n=30) or SWT (n=30) for 6 continuous days per month during the following 6 months and vice versa with one month of washout period in between. During the initial, 3rd, 6th, 10th, and 13th months anthropometric measurements were performed as well as fasting blood samples were drawn for various biochemical assays. Abdominal ultrasonic and skin examination were performed at the initial, 6th and 13th months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy adults
Exclusion Criteria:
- exclusion criteria were history of smoking, alcoholism
- pregnant or lactating women,
- chronic diseases, hepatic or renal dysfunction.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Si-Wu-Tang (SWT)
Subjects are recommended to drink 125 mL of SWT (n=30) for 6 continuous days per month during the following 6 months and vice versa with one month of washout period in between.
|
The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.
Other Names:
The purpose of the current study was to check the physiological improvement of placebo on liver and skin and also the antioxidation in healthy adults.
|
Placebo Comparator: placebo
Subjects are recommended to drink 125 mL of Placebo (n=30) for 6 continuous days per month during the following 6 months and vice versa with one month of washout period in between.
|
The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.
Other Names:
The purpose of the current study was to check the physiological improvement of placebo on liver and skin and also the antioxidation in healthy adults.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total thiobarbituric acid reactive substances (TBARS)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glutathione content (GSH)
Time Frame: 6 months
|
6 months
|
Total antioxidant capacity (TEAC)activities.
Time Frame: 6 months
|
6 months
|
Superoxide dismutase (SOD) activity
Time Frame: 6 months
|
6 months
|
GPx and glutathione reductase (GR) activity
Time Frame: 6 months
|
6 months
|
Catalase
Time Frame: 6 months
|
6 months
|
Glutamic oxaloacetic transaminase (GOT)
Time Frame: 6 months
|
6 months
|
Glutamic pyruvic transaminase (GPT)
Time Frame: 6 months
|
6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Skin sebum content
Time Frame: 6 months
|
6 months
|
Skin hydration
Time Frame: 6 months
|
6 months
|
Skin surface water loss
Time Frame: 6 months
|
6 months
|
Skin melanin index
Time Frame: 6 months
|
6 months
|
Skin elasticity
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Chin-Kun Wang, Chung Shan Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CS08008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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