Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00165

2 Trial Registration Date

2008-07-11

i Registration Status

Prospective

3 Secondary IDs

NIL

4 Source(s) of Funding

Joint Shantou International Eye Center, Shantou, Guangdong Province, China

5 Primary Sponsor

Professor Nathan Congdon, Zhongshan Ophthalmic Center

6 Secondary Sponsor

Professor Zhang Mingzhi, Director of Joint Shantou International Eye Center

Function

Please specify

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

i Name

Nathan Congdon

ii Address

ZOC, Guangzhou, China

iii Phone

Phone: +86 13925056342

iv Email

Email: ncongdon1@gmail.com

v Affiliation

CUHK/JSIEC/ZOC

vi Country

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

i Name

Nathan Congdon

ii Address

As above

iii Phone

As above

iv Email

As above

v Affiliation

CUHK/JSIEC/ZOC

vi Country

9 Official Scientific Title of the Study

Randomized, Short-term Trial of Gingko Biloba in the Treatment of Normal Tension and High-Tension Glaucoma

10 Public Title

Randomized, Short-term Trial of Gingko Biloba in the Treatment of Normal Tension and High-Tension Glaucoma

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

NIL

12 Countries of Recruitment

China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-05-16

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Normal Tension Glaucoma, High Tension Glaucoma

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Gingko Biloba 240mg QD

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Eight weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo - Calcium tablets

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: A. Definite glaucomatous VF (at least three contiguous points in one hemi-field abnormal below the 1% level, two of which are observed on three successive VF tests) and disc damage (CDR >= 0.7 and/or a rim width of <= 0.1 in at least one quadrant, as graded by a glaucoma specialist) in at least one eye. B. For NTG: Average of two highest readings on 12-hour IOP testing off of any ocular hypertensive treatment are <= 18 mmHg C. For pressure-dependent glaucoma: Documented IOP >= 22 mmHg on at least two occasions

ii Exclusion Criteria

Exclusion Criteria: a. Any history of dementia or other cognitive abnormality, or evidence on examination or history of non-ocular causes for VF loss. b. Any evidence of disc pallor, retinal abnormality or other finding on ocular examination to suggest an ocular cause other than glaucoma for the VF loss or disc abnormality. c. Need for surgical intervention of any kind, or change in medication within one month of initiating participation in the study.

iii Age Minimum

18

iv Age Maximum

None

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

Crossover

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-07-18

21 Target Sample Size

32

22 Recruitment Status

Recruiting

23 Primary Outcome

a. Visual field: MD, CPSD, and change in these two parameters before and after treatment over 8 weeks. b. Optic nerve blood flow, and change before and after treatment over 8 weeks. c. Visual function and change before and after treatment d. Effect of treatment type (GBE versus placebo) on the three above parameters e. Effect of glaucoma type (NTG versus pressure-dependent) on changes in VF, visual function and blood flow parameters

24 Secondary Outcome

f. Change in effect on blood flow, visual function and VF parameters with continued treatment over time with GBE (total of 8 months after cessation of randomized therapy)

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-05-06

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000724

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

28 patients recruited

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Trial History Detail on 2012-04-04