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Trial Detail

CUHK_CCRB00596

2018-03-15

Prospective

CREC Ref no. 2018.004

Protocol no. 2018-HL-001

This is no a funded project

N/A

N/A

Not Applicable

Ka Lai Yip

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

3505 3856

Hannahykl@cuhk.edu.hk

Division of Neurology, The Chinese University of Hong Kong

Hong Kong

Ho Wan Leung

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

35053856

Howanleung@cuhk.edu.hk

Division of Neurology, The Chinese University of Hong Kong

Hong Kong

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

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

使用天麻水提物紓緩惡性難治腦癇症患者的發作情況

Hong Kong

Yes

2018-03-05

Joint CUHK-NTEC Clinical Research Ethics Committee

CREC Ref. No: 2018.004

Refractory epilepsy

Other

Herbal supplement

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.

Powder

4.5 grams daily

12 weeks

Once per day

Placebo treatment without bio-active ingredients

Powder

4.5 grams daily

12 weeks

Once per day

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

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

18

999

Both Male and Female

Interventional

Non-randomized

Placebo

Open label

Parallel

Other

Supplement

2018-05-01

120

Not Yet Recruiting

Seizure-freedom

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

12 weeks

Seizure frequency

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.

12 weeks

Tolerailibilty

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

12 weeks

No

2018-07-05

ChiCTR1800015349

2018-03-15

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