Chronic Stress-Induced StrainNCT03277833
Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
A study testing Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day) in people with Chronic Stress-Induced Strain, run by Chonbuk National University Hospital.
Trial summary
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stress-Induced Strain
- What is being tested?
- Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jan 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20-65 years with chronic stress( S-STAI score 40~60)
Who cannot join
- excessive physically chronic fatigue
- Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior to the study
- Cardiovascular disease
- Allergic or hypersensitive to any of the ingredients in the test products
- History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
- Participation in any other clinical trials within past 2 months
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- Renal disease
- Abnormal hepatic function
- Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- History of alcohol or substance abuse
- Pregnancy or lacting women etc.
About this study
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. The investigators measured decrement of body fat parameters, State\&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety Inventory(HAM-A), and monitored their blood pressure.
- Conditions
- Chronic Stress-Induced Strain
- Being tested
- Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)Dietary supplement
Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design
PlaceboDietary supplement
Placebo, parallel design
| Study group | Role | What they receive |
|---|---|---|
| Gynostemma Pentaphyllum(Dungkulcha) Extract | Experimental | Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d) Receives: Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day) |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score of State&Trait version of STAI
Score of State\&Trait version of STAI was measured in study screening and visit 3(8 week).
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Change of Blood Norepinephrine Level
Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).
Measured: Baseline and 8 week
Change of Blood Cortisol Level
Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week).
Measured: Baseline and 8 week
Change in score of Beck Anxiety Inventory
Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week).
Measured: Baseline and 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study startMar 2013
- Primary completionApr 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stress-Induced StrainStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277833
- Sponsor's protocol ID
- CBU-STR-DOLWOE
- Status last verified
- Sep 2017
- First submitted
- 13 May 2016
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
- ClinicalTrials.gov ID
- NCT03277833
- Acronym / sponsor ID
- CBU-STR-DOLWOE
- Conditions
- Chronic Stress-Induced Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Sep 2017 (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.
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. The investigators measured decrement of body fat parameters, State\&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety Inventory(HAM-A), and monitored their blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gynostemma Pentaphyllum(Dungkulcha) Extract | Experimental | Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 20-65 years with chronic stress( S-STAI score 40~60)
Key exclusion criteria (11 listed)
- excessive physically chronic fatigue
- Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior to the study
- Cardiovascular disease
- Allergic or hypersensitive to any of the ingredients in the test products
- History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
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 |
|---|---|---|
| Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design | Dietary supplement | Gynostemma Pentaphyllum(Dungkulcha) Extract |
| PlaceboPlacebo, parallel design | Dietary supplement | Placebo |
Primary outcome
Change in score of State&Trait version of STAI
Time frame: Baseline and 8 weeks
Score of State\&Trait version of STAI was measured in study screening and visit 3(8 week).
3 secondary outcomes
Change of Blood Norepinephrine Level
Time frame: Baseline and 8 week
Change of Blood Cortisol Level
Time frame: Baseline and 8 week
Change in score of Beck Anxiety Inventory
Time frame: Baseline and 8 week
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 11 Sep 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day) in people with Chronic Stress-Induced Strain, run by Chonbuk National University Hospital.
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 11 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 11 Sep 2017. 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?
Change in score of State&Trait version of STAI (time frame: Baseline and 8 weeks). 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 11 Sep 2017.