Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00596

2 Trial Registration Date

2018-03-15

i Registration Status

Prospective

3 Secondary IDs

CREC Ref no. 2018.004

Protocol no. 2018-HL-001

4 Source(s) of Funding

This is no a funded project

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ka Lai Yip

ii Address

Room 124010,
10/F, Lui Che Woo Clinical Sciences Building,
Price of Wales Hospital,
30-32 Ngan Shing Street,
Shatin, New Territories

iii Phone

3505 3856

iv Email

Hannahykl@cuhk.edu.hk

v Affiliation

Division of Neurology, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Ho Wan Leung

ii Address

Division of Neurology,
Department of Medicine & Therapeutics,
Price of Wales Hospital, Shatin

iii Phone

35053856

iv Email

Howanleung@cuhk.edu.hk

v Affiliation

Division of Neurology, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Water extract of Gastrodiae Rhizoma as a supplement for refractory epilepsy: a translation of basic research to clinical practice

10 Public Title

Water extract of Gastrodiae Rhizoma as a supplement for refractory epilepsy: a translation of basic research to clinical practice

i Public Title in Chinese 研究名稱

使用天麻水提物紓緩惡性難治腦癇症患者的發作情況

11 Short Title (Optional)

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?

2018-03-05

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC Ref. No: 2018.004

14 Medical Condition Being Studied

Refractory epilepsy

15 Intervention

i Types of intervention

Other

Please specify

Herbal supplement

ii Description/ name of Intervention/article

A prospective design is adopted for subject recruitment. The present study is randomized, open-label and placebo-controlled clinical trial for adopting the water extract of Gastrodiae Rhizoma for refractory epilepsy subjects. This study will collect information about demographic details, medical history and whole blood. The seizure information will collect based on subjects’ seizure diary (electronic available on personal cell phone or written version provided by Hong Kong Epilepsy Society). Clinical assessments will be done with subjects and/or with their care-givers by face-to-face interview. The EEG signals, laboratory results and other relevant information will also be collected.

iii Dosage form of the intervention

Powder

iv Dosage of the intervention

4.5 grams daily

v Duration of the intervention

12 weeks

vi Frequency of the intervention

Once per day

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo treatment without bio-active ingredients

ii Dosage form of the comparative treatments

Powder

iii Dosage of the comparative treatments

4.5 grams daily

iv Duration of the comparative treatments

12 weeks

v Frequency of the comparative treatments

Once per day

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Subject aged 18 years or above

Subject has a diagnosis of refractory epilepsy

Persistent seizures despite sequential or add-on therapy with 2 or more antiepileptic drugs

At least one or more non-seizure symptoms including and not limited to dizziness, vertigo, headache, insomnia, cognitive impairment and behavioural problem

Subject able to speak and listen Chinese

ii Exclusion Criteria

Abnormal renal and liver functions at baseline

Concomitant antipsychotic drugs or serotonin-reuptake inhibitors

Substance abuse

Pregnancy or breastfeeding

Active history of malignancy

Unwillingness to give consent for herbal supplementation with GR by the subject or the care-taker of the subject.

Neurodegenerative conditions with predicted survival less than 6 months

Active history of cardiovascular conditions

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Supplement

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-05-01

21 Target Sample Size

120

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Seizure-freedom

ii The metric or method of measurement used

The day of achieving seizure-freedom will be recorded in baseline, maintenance and treatment phases

iii The timepoint(s) of primary interest

12 weeks

Primary Outcome

i The Name of the outcome

Seizure frequency

ii The metric or method of measurement used

50% responder rate will be calculated according to seizure frequency in baseline, maintenance phase. It is defined as the number of subjects achieving more than 50% reduction in seizure counts over the maintenance period.

iii The timepoint(s) of primary interest

12 weeks

24 Secondary Outcome

i The Name of the outcome

Tolerailibilty

ii The metric or method of measurement used

The behavioural disturbances effect will be recorded by Neuropsychiatric Inventory Questionnaire.

iii The timepoint(s) of primary interest

12 weeks

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-07-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-03-15