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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02634242
Other study ID # CS08008
Secondary ID
Status Completed
Phase N/A
First received December 8, 2015
Last updated December 15, 2015
Start date April 2008
Est. completion date April 2009

Study information

Verified date December 2015
Source Chung Shan Medical University
Contact n/a
Is FDA regulated No
Health authority Taiwan: National Health Research Institutes
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- healthy adults

Exclusion Criteria:

- exclusion criteria were history of smoking, alcoholism

- pregnant or lactating women,

- chronic diseases, hepatic or renal dysfunction.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Other:
Si-Wu-Tang (SWT)
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.
placebo
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chung Shan Medical University

Outcome

Type Measure Description Time frame Safety issue
Other Skin sebum content 6 months No
Other Skin hydration 6 months No
Other Skin surface water loss 6 months No
Other Skin melanin index 6 months No
Other Skin elasticity 6 months No
Primary Total thiobarbituric acid reactive substances (TBARS) 6 months No
Secondary Glutathione content (GSH) 6 months No
Secondary Total antioxidant capacity (TEAC)activities. 6 months No
Secondary Superoxide dismutase (SOD) activity 6 months No
Secondary GPx and glutathione reductase (GR) activity 6 months No
Secondary Catalase 6 months No
Secondary Glutamic oxaloacetic transaminase (GOT) 6 months No
Secondary Glutamic pyruvic transaminase (GPT) 6 months No