Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00173

2 Trial Registration Date

2009-02-21

i Registration Status

Retrospective

3 Secondary IDs

ICM/CTS/08/348

4 Source(s) of Funding

Institute of Chinese Medicine

5 Primary Sponsor

Department of Paediatrics, CUHK

6 Secondary Sponsor

Department of Biology, CUHK
Institute of Chinese Medicine, CUHK

Function

Please specify

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

i Name

Yvonne Chu (Research Assistant)

ii Address

Department of Paediatrics, Prince of Wales Hospital, CUHK

iii Phone

2632 1220

iv Email

yvonnechu@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Prince of Wales Hospital, CUHK

vi Country

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

i Name

Prof. Li Chi Kong (PI)

ii Address

Department of Paediatrics, Prince of Wales Hospital, CUHK

iii Phone

2632 1029

iv Email

ckli@cuhk.edu.hk

v Affiliation

Department of Paediatrics, Prince of Wales Hospital, CUHK

vi Country

9 Official Scientific Title of the Study

Pilot Study of Efficacy and safety of Chinese Herbal Medicine Gualou (fructus trichosanthis) in Treating beta-thalassaemia Intermedia Patients

10 Public Title

Pilot Study of Efficacy and safety of Chinese Herbal Medicine Gualou (fructus trichosanthis) in Treating beta-thalassaemia Intermedia Patients

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Safety and efficacy of Gualou for Thalassaemia treatment

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?

2008-11-14

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Beta-thalassaemia Intermedia Patients and aged > 5 years old

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Gua Lou

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

52 week

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

It is a prospective self-controlled study. No Comparative/control intervention

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

Inclusion Criteria
 BTI with diagnosis based on Hb electrophoresis pattern
 Age > 5
 Not transfusion dependent with less than 4 times of transfusion in recent 1 year
 Hb < 10g/dL at baseline

ii Exclusion Criteria

Exclusion Criteria
 ALT > 3 times of upper limit of normal
 Renal impairment with serum Cr above upper limit of normal
 Chronic hepatitis B and C infection
 Receiving other long term herbal medications

iii Age Minimum

5

iv Age Maximum

No Upper Limit

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-11-01

21 Target Sample Size

20

22 Recruitment Status

Complete

23 Primary Outcome

Change in HbF at 52 weeks

24 Secondary Outcome

Changes in Hb and F-cell production at 52 weeks

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-20

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000728

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2011-02-08