Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00392

2 Trial Registration Date

2014-01-28

i Registration Status

Prospective

3 Secondary IDs

CRE-2012.561-T

4 Source(s) of Funding

Health Medical Research Fund

5 Primary Sponsor

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Edwina So

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

26322931

iv Email

edwinaso@cuhk.edu.hk

v Affiliation

CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Bryan Yan

ii Address

Department of Medicine & Therapeutics, The Chinese University of Hong Kong

iii Phone

26323878

iv Email

bryan.yan@cuhk.edu.hk

v Affiliation

CUHK

vi Country

9 Official Scientific Title of the Study

Novel Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule

10 Public Title

Novel Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease Using Danshen Gegen (D&G) Capsule

i Public Title in Chinese 研究名稱

丹參葛根膠囊治療間隔性跛行伴外周動脈疾病的臨床研究

11 Short Title (Optional)

TCM study

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-07-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Intermittent Claudication in Patients with Peripheral Arterial Disease

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Traditional Chinese Medicine Salviae miltiorrhizae (Danshen) and Puerariae lobatae (Gegen)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Men and women 40 years or older
2. With stable intermittent claudication secondary to PAD defined as resting ABI <0.90 and a ≥10mmHg decrease in ankle artery blood pressure after exercise.
3. No change in existing therapy for claudication within 3 months of study enrollment.

ii Exclusion Criteria

1. Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene
2. Major lower limb amputation
3. Surgical or endovascular revascularization for PAD within 3 months prior to enrolment
4. Exercise limitation due to significant concomitant disease (e.g. severe arthritis, cardiac or pulmonary disease)
5. Pregnant women and women who are breastfeeding
6. Patients who are currently on Warfarin
7. Patients with resting systolic blood pressure below 100mmHg (SBP < 100mmHg)

iii Age Minimum

40

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-05-04

21 Target Sample Size

226

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Primary efficacy measure: change in total distance walked from beginning treadmill walking until the subject can walk no further

24 Secondary Outcome

Secondary efficacy endpoints: change in distance walked at the onset of claudication, QoL, functional status, ABI before and after exercise, combined cardiovascular events including vascular death, myocardial infarction, stroke, revascularization or readmission to hospital for a vascular or atherosclerosis-related complication

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-05-07

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14004215

28 Date of Registration in Primary Registry

2014-01-28

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2015-05-07