Gynecological DisordersNCT02634242
Study on the Antiaging Effect of Chinese Herb Drink
A study testing Si-Wu-Tang (SWT) in people with Gynecological Disorders, run by Chung Shan Medical University.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gynecological Disorders
- What is being tested?
- Si-Wu-Tang (SWT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Apr 2009
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
Who cannot join
- pregnant or lactating women,
- chronic diseases, hepatic or renal dysfunction.
About this study
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.
Read the 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.
- Conditions
- Gynecological Disorders
- Being tested
- Si-Wu-Tang (SWT), placebo
- Keywords
- Si Wu Tang, antioxidation, anthropometric measurements, liver, skin
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Si-Wu-Tang (SWT)Other
Also called Si-Wu-Tang (SWT) is a Traditional Chinese Medicine formula
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Si-Wu-Tang (SWT); Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total thiobarbituric acid reactive substances (TBARS)
Measured: 6 months
Secondary outcomes (7)
Glutathione content (GSH)
Measured: 6 months
Total antioxidant capacity (TEAC)activities.
Measured: 6 months
Superoxide dismutase (SOD) activity
Measured: 6 months
GPx and glutathione reductase (GR) activity
Measured: 6 months
Catalase
Measured: 6 months
Glutamic oxaloacetic transaminase (GOT)
Measured: 6 months
Glutamic pyruvic transaminase (GPT)
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 posted18 Dec 2015 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological DisordersStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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, Study chair, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634242
- Sponsor's protocol ID
- CS08008
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Antiaging Effect of Chinese Herb Drink
- ClinicalTrials.gov ID
- NCT02634242
- Acronym / sponsor ID
- CS08008
- Conditions
- Gynecological Disorders
- Keywords
- Si Wu Tang, antioxidation, anthropometric measurements, liver, skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Dec 2015 (estimated)
- 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.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Si-Wu-Tang (SWT) | Experimental | Other: Si-Wu-Tang (SWT), Other: placeboSubjects 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. |
| placebo | Placebo comparator | Other: Si-Wu-Tang (SWT), Other: placeboSubjects 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (2 listed)
- pregnant or lactating women,
- chronic diseases, hepatic or renal dysfunction.
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 |
|---|---|---|
| Si-Wu-Tang (SWT)Also: Si-Wu-Tang (SWT) is a Traditional Chinese Medicine formulaThe 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 | Si-Wu-Tang (SWT), placebo |
| placeboThe purpose of the current study was to check the physiological improvement of placebo on liver and skin and also the antioxidation in healthy adults. | Other | Si-Wu-Tang (SWT), placebo |
Primary outcome
Total thiobarbituric acid reactive substances (TBARS)
Time frame: 6 months
7 secondary outcomes
Glutathione content (GSH)
Time frame: 6 months
Total antioxidant capacity (TEAC)activities.
Time frame: 6 months
Superoxide dismutase (SOD) activity
Time frame: 6 months
GPx and glutathione reductase (GR) activity
Time frame: 6 months
Catalase
Time frame: 6 months
Glutamic oxaloacetic transaminase (GOT)
Time frame: 6 months
Glutamic pyruvic transaminase (GPT)
Time frame: 6 months
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 18 Dec 2015.
Related trials for Gynecological Disorders
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
Methylation Analyses for Gynaecological Research Through Home-based Self-sampling
Healthy Adult Participants, Gynecological Disease
RecruitingObservational study
GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications
GYN Disorders
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
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 study chair
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Si-Wu-Tang (SWT) in people with Gynecological Disorders, run by Chung Shan Medical University.
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 1 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 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Total thiobarbituric acid reactive substances (TBARS) (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 18 Dec 2015.