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

iRegistration Status

Prospective

3 Secondary IDs

CRE-2012.561-T

4 Source(s) of Funding

pending for the approval of 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

7Responsible 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

8Research 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

26323846

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 Traditional Chinese Medicine

10 Public Title

Novel Treatment of Intermittent Claudication in Patients with Peripheral Arterial Disease Using Traditional Chinese Medicine

i Public Title in Chinese 研究名稱

患間隔性跛行病徵之外周動脈疾病患者使用中草藥的嶄新治療研究

11 Short Title (Optional)

TCM study

12 Countries of Recruitment

Hong Kong

13Research 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

15Intervention

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

16Comparative 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

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Men and women 40 years or older; at least 3-month history of stable IC (Rutherford class 2 or 3) secondary to lower extremity PAD; PAD defined as resting ABI <0.90 in at least 1 limb and a ≥10mmHg decrease in ankle artery blood pressure after exercise. In patients with non-compressible vessels (ABI >1.50), the toe–brachial index (TBI) at rest has to be <0.70; Reproducible walking distances with <25% variance between 2 baseline treadmill tests and who terminated all screening treadmill tests solely because of IC pain

ii Exclusion Criteria

Critical limb ischemia defined by ischemic rest pain, ulceration, or gangrene (Rutherford class ≥4); Major lower limb amputation (above or below knee amputation); Surgical or endovascular revascularization for PAD within 3 months; Exercise limitation due to significant concomitant disease (e.g. severe hip or knee arthritis, coronary artery disease, heart failure, chronic obstructive airway disease); Concomitant anticoagulation therapy (e.g. warfarin); Pregnancy or breastfeeding; Unable to complete the screening and follow-up treadmill protocols

iii Age Minimum

40

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Interventional

19Study 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

2014-07-01

21 Target Sample Size

272

22 Recruitment Status

Unknown

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

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last 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?

No

ii Link to Recruitment Information

Nil

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Trial History Detail on 2015-03-01