NCT01033630

Brief Summary

Atherosclerosis (in particular stroke and heart attack) is the most important health issue in modernized society and high blood pressure is an important predisposing factor. Hypertensive subjects with other chronic disease such as diabetes mellitus or impaired renal function are particularly vulnerable to these atherosclerotic complications in spite of standard antihypertensive therapies. Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac symptoms and atherosclerosis-related disorders. The objective of this study is to test Danshen and Gegen as an cardiovascular-protective adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Jan 2006

Typical duration for phase_2 hypertension

Geographic Reach
1 country

3 active sites

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

January 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
Last Updated

December 16, 2009

Status Verified

January 1, 2006

Enrollment Period

2.3 years

First QC Date

December 15, 2009

Last Update Submit

December 15, 2009

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Ultrasound study for measuring carotid intima-media thickening (IMT)

    1 year

Secondary Outcomes (1)

  • Blood tests: lipids, creatinine, glucose, fibrinogen, hs-CRP and haemoglobin A1-C Physical examination: Blood pressure, weight, height, body mass index, hip waist ratio

    1 year

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Image-matched placebo of active treatment

Drug: Placebo

D&G 1g

ACTIVE COMPARATOR

Randomly allocated into three groups, D\&G capsule 1g/day

Drug: D&G 1g

D&G 2g

ACTIVE COMPARATOR

Randomly allocated into three groups, D\&G capsule 2g/day

Drug: D&G 2g

Interventions

D&G 2gDRUG

Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge. Gegen is the dried roots of Pueraria lobata (willd.). The combination in the ratio of 7:3 of the raw herbs. Capsule form, Orally taken 2g per Day

Also known as: Danshen Gegen
D&G 2g
D&G 1gDRUG

Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge. Gegen is the dried roots of Pueraria lobata (willd.). The combination in the ratio of 7:3 of the raw herbs. Capsule form, Orally taken 1g per Day

Also known as: Danshen Gegen
D&G 1g
PlaceboDRUG

Image-matched placebo, made with starch.

Placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High-risk hypertension: Asymptomatic hypertensive (pretreatment BP\>160/95mmHg) subjects, currently blood pressure under control (BP\<140/90mmHg),
  • Aged 35-70 years
  • With either (i)left ventricular hypertrophy on ECG or echocardiographic criteria, (ii) diabetes mellitus, or (iii) mild renal impairment (plasma creatinine 120-250µmol/l)

You may not qualify if:

  • Known intolerance to D\&G due to adverse effect, patients with bleeding, disorders or on long-term anticoagulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Yan Chai Hospital

Hong Kong, Hong Kong

Location

Related Publications (4)

  • Bots ML, Hoes AW, Koudstaal PJ, Hofman A, Grobbee DE. Common carotid intima-media thickness and risk of stroke and myocardial infarction: the Rotterdam Study. Circulation. 1997 Sep 2;96(5):1432-7. doi: 10.1161/01.cir.96.5.1432.

    PMID: 9315528BACKGROUND

  • O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.

    PMID: 9878640BACKGROUND

  • Woo KS, Chook P, Raitakari OT, McQuillan B, Feng JZ, Celermajer DS. Westernization of Chinese adults and increased subclinical atherosclerosis. Arterioscler Thromb Vasc Biol. 1999 Oct;19(10):2487-93. doi: 10.1161/01.atv.19.10.2487.

    PMID: 10521379BACKGROUND

  • Sieveking DP, Woo KS, Fung KP, Lundman P, Nakhla S, Celermajer DS. Chinese herbs Danshen and Gegen modulate key early atherogenic events in vitro. Int J Cardiol. 2005 Oct 20;105(1):40-5. doi: 10.1016/j.ijcard.2004.10.052.

    PMID: 16207543BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Danshen-Gegen

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas YK Chan, Prof.

    Department of Medicine & Therapeutics, Prince of Wales hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

January 1, 2006

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 16, 2009

Record last verified: 2006-01

Locations

HK(3)