HealthyNCT02007304
Effects of Panax Ginseng and Salvia Miltiorrhiza Supplementation on Vascular Function
A study testing Eccentric exercise training in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of is to determine the preventive effects of Chinese herb supplement with panax ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness and vascular reactivity by using a double-blind randomized control design and to examine the effects of a 12-week progressive… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Eccentric exercise training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2012to Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Healthy sedentary adults
Who cannot join
- obesity (BMI >30 kg/m2)
- smoking within past six months
- hypertension (high blood pressure >140/90 mmHg)
- personal history of diabetes (fasting blood glucose >126 mg/dL), heart disease, or other cardiovascular problems
- orthopedic injury that may prevent him or her from completing the exercise
- the use of over-the-counter supplements or vitamins
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei, 106
Hsin-Fu Lin, Ph.D, +886932873163, hsinfu@ntu.edu.tw
About this study
Official title: Effects of Panax Ginseng and Salvia Miltiorrhiza Supplementation on Preventing Arterial Stiffening Effects Induced by Acute and Chronic Eccentric Exercise
The purpose of is to determine the preventive effects of Chinese herb supplement with panax ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness and vascular reactivity by using a double-blind randomized control design and to examine the effects of a 12-week progressive eccentric resistance exercise training on arterial elasticity and vascular reactivity, and whether a long-term supplementation would ameliorate arterial stiffening effects elicited by exercise-induced inflammation and improve endothelial function.
- Conditions
- Healthy
- Being tested
- Eccentric exercise training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exercise trainingBehavioural
12 weeks of lower leg eccentric training
| Study group | Role | What they receive |
|---|---|---|
| Herbs | Experimental | participants assigned to experimental arm will take 300mg panax ginseng and 300mg salvia miltiorrhiza extracts in capsules for 12 weeks along with eccentric exercise training Receives: Behavioral: Eccentric exercise training |
| Placebo | Placebo comparator | parcipants in this group will take placebo capsule containing microcrystalline cellulose Receives: Behavioral: Eccentric exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity
PWV will be measured before, 6th week, 12th week of eccentric exercise training.
Measured: Before eccentric exercise and training
Pulse Wave Velocity
PWV will be measured before, 6th week, 12th week of eccentric exercise training.
Measured: 6th week of eccentric exercise traininig
Pulse Wave Velocity
PWV will be measured before, 6th week, 12th week of eccentric exercise training.
Measured: 12th week of eccentric exercise training
Secondary outcomes (3)
Blood pressure
Morning blood pressure will be measured before, during, and after 12 week of dietary and eccentric exercise intervention.
Measured: Before intervention
Blood pressure
Morning blood pressure will be measured before, 6th, and after 12 week of dietary and eccentric exercise intervention.
Measured: 6th week of intervention
Blood pressure
Morning blood pressure will be measured before, during, and after 12 week of dietary and eccentric exercise intervention.
Measured: 12th week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2012
- Primary completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsin-Fu Lin, Ph.D, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007304
- Sponsor's protocol ID
- 201112068MIB
- Status last verified
- Dec 2013
- First submitted
- 4 Dec 2013
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin HF, Chou CC, Chao HH, Tanaka H. Panax ginseng and Salvia miltiorrhiza supplementation during eccentric resistance training in middle-aged and older adults: A double-blind randomized control trial. Complement Ther Med. 2016 Dec;29:158-163. doi: 10.1016/j.ctim.2016.10.003. Epub 2016 Oct 11.
PubMed 27912940Lin HF, Tung K, Chou CC, Lin CC, Lin JG, Tanaka H. Panax ginseng and salvia miltiorrhiza supplementation abolishes eccentric exercise-induced vascular stiffening: a double-blind randomized control trial. BMC Complement Altern Med. 2016 Jun 6;16:168. doi: 10.1186/s12906-016-1139-4.
PubMed 27266702
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Panax Ginseng and Salvia Miltiorrhiza Supplementation on Preventing Arterial Stiffening Effects Induced by Acute and Chronic Eccentric Exercise
- ClinicalTrials.gov ID
- NCT02007304
- Acronym / sponsor ID
- 201112068MIB
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (estimated)
- First posted
- 10 Dec 2013 (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 is to determine the preventive effects of Chinese herb supplement with panax ginseng and salvia miltiorrhiza prior to eccentric resistance exercise on arterial stiffness and vascular reactivity by using a double-blind randomized control design and to examine the effects of a 12-week progressive eccentric resistance exercise training on arterial elasticity and vascular reactivity, and whether a long-term supplementation would ameliorate arterial stiffening effects elicited by exercise-induced inflammation and improve endothelial function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Herbs | Experimental | Behavioral: Eccentric exercise trainingparticipants assigned to experimental arm will take 300mg panax ginseng and 300mg salvia miltiorrhiza extracts in capsules for 12 weeks along with eccentric exercise training |
| Placebo | Placebo comparator | Behavioral: Eccentric exercise trainingparcipants in this group will take placebo capsule containing microcrystalline cellulose |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Healthy sedentary adults
Key exclusion criteria (6 listed)
- obesity (BMI >30 kg/m2)
- smoking within past six months
- hypertension (high blood pressure >140/90 mmHg)
- personal history of diabetes (fasting blood glucose >126 mg/dL), heart disease, or other cardiovascular problems
- orthopedic injury that may prevent him or her from completing the exercise
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 |
|---|---|---|
| Eccentric exercise training12 weeks of lower leg eccentric training | Behavioural | Herbs, Placebo |
Primary outcome
Pulse Wave Velocity
Time frame: Before eccentric exercise and training
PWV will be measured before, 6th week, 12th week of eccentric exercise training.
Pulse Wave Velocity
Time frame: 6th week of eccentric exercise traininig
PWV will be measured before, 6th week, 12th week of eccentric exercise training.
Pulse Wave Velocity
Time frame: 12th week of eccentric exercise training
PWV will be measured before, 6th week, 12th week of eccentric exercise training.
3 secondary outcomes
Blood pressure
Time frame: Before intervention
Blood pressure
Time frame: 6th week of intervention
Blood pressure
Time frame: 12th week of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Derived from this study: PubMed 27912940Lin HF, Chou CC, Chao HH, Tanaka H. Panax ginseng and Salvia miltiorrhiza supplementation during eccentric resistance training in middle-aged and older adults: A double-blind randomized control trial. Complement Ther Med. 2016 Dec;29:158-163. doi: 10.1016/j.ctim.2016.10.003. Epub 2016 Oct 11.
- Derived from this study: PubMed 27266702Lin HF, Tung K, Chou CC, Lin CC, Lin JG, Tanaka H. Panax ginseng and salvia miltiorrhiza supplementation abolishes eccentric exercise-induced vascular stiffening: a double-blind randomized control trial. BMC Complement Altern Med. 2016 Jun 6;16:168. doi: 10.1186/s12906-016-1139-4.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Hsin-Fu Lin, Ph.D principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise training in people with Healthy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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: status not confirmed, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Fu Lin, Ph.D. (+886932873163, hsinfu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity (time frame: Before eccentric exercise and training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02007304, which also lists 2 linked publications.
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 10 Dec 2013.