NCT02007304

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 10, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

1.7 years

First QC Date

December 4, 2013

Last Update Submit

December 5, 2013

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pulse Wave Velocity

    PWV will be measured before, 6th week, 12th week of eccentric exercise training.

    Before eccentric exercise and training

  • Pulse Wave Velocity

    PWV will be measured before, 6th week, 12th week of eccentric exercise training.

    6th week of eccentric exercise traininig

  • Pulse Wave Velocity

    PWV will be measured before, 6th week, 12th week of eccentric exercise training.

    12th week of eccentric exercise training

Secondary Outcomes (3)

  • Blood pressure

    Before intervention

  • Blood pressure

    6th week of intervention

  • Blood pressure

    12th week of intervention

Study Arms (2)

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

Behavioral: Eccentric exercise training

Placebo

PLACEBO COMPARATOR

parcipants in this group will take placebo capsule containing microcrystalline cellulose

Behavioral: Eccentric exercise training

Interventions

12 weeks of lower leg eccentric training

HerbsPlacebo

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy sedentary adults

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, 106, Taiwan

RECRUITING

Related Publications (2)

  • 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.

  • Lin 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.

Study Officials

  • Hsin-Fu Lin, Ph.D

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsin-Fu Lin, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 10, 2013

Study Start

November 1, 2012

Primary Completion

July 1, 2014

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations