NCT02634242

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

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

April 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

December 8, 2015

Last Update Submit

December 15, 2015

Conditions

Gynecological Disorders

Keywords

Si Wu Tangantioxidationanthropometric measurementsliverskin

Outcome Measures

Primary Outcomes (1)

  • Total thiobarbituric acid reactive substances (TBARS)

    6 months

Secondary Outcomes (7)

  • Glutathione content (GSH)

    6 months

  • Total antioxidant capacity (TEAC)activities.

    6 months

  • Superoxide dismutase (SOD) activity

    6 months

  • GPx and glutathione reductase (GR) activity

    6 months

  • Catalase

    6 months

  • +2 more secondary outcomes

Other Outcomes (5)

  • Skin sebum content

    6 months

  • Skin hydration

    6 months

  • Skin surface water loss

    6 months

  • +2 more other outcomes

Study Arms (2)

Si-Wu-Tang (SWT)

EXPERIMENTAL

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.

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

placebo

PLACEBO COMPARATOR

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.

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

Interventions

Si-Wu-Tang (SWT)OTHER

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.

Also known as: Si-Wu-Tang (SWT) is a Traditional Chinese Medicine formula
Si-Wu-Tang (SWT)placebo
placeboOTHER

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.

Si-Wu-Tang (SWT)placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults

You may not qualify if:

  • pregnant or lactating women,
  • chronic diseases, hepatic or renal dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

si-wu-tang

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Chin-Kun Wang

    Chung Shan Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 18, 2015

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 18, 2015

Record last verified: 2015-12