A clinical study of bojungikgitang and banhabaekchulchonmatang in adult tinnitus patients

ISRCTN	ISRCTN23691284
DOI	https://doi.org/10.1186/ISRCTN23691284
Secondary identifying numbers	B08-0045-AM0829-08N1-00010A

Submission date: 25/05/2009
Registration date: 05/06/2009
Last edited: 29/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Donghyo Lee
Scientific

Wonkwang University Oriental Medical Center
1126-1 Sanbon-dong
Gunpo
435-040
Korea, South

Email	secretop17@naver.com

Study information

Study design	Randomised phase III double-blind three-arm placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A clinical study of bojungikgitang and banhabaekchulchonmatang in adult tinnitus patients: a randomised, double-blind, three-arm, placebo-controlled trial
Study objectives	This study is aimed to evaluate the efficacy and safety of bojungikgitang and banhabaekchulchonmatang in adult tinnitus patients.
Ethics approval(s)	Wonkwang University Oriental Medical Center Ethics Committee gave approval on the 25th February 2009
Health condition(s) or problem(s) studied	Tinnitus
Intervention	This study is a randomised, double-blind, placebo-controlled study. Participants will receive bojungikgitang, banhabaekchulchonmatang, or a placebo-drug for 8 weeks. Oral administration occurs according to the following statements: 1. Patients in group 1 receive bojungikgitang and instructions on how to make a tea; they take a packet of the medicine (12.52 g) with tepid water for three times a day after meal 2. Patients in group 2 receive banhabaekchulchonmatang and instructions on how to make a tea; they take a packet of the medicine (12.52 g) with tepid water for three times a day after meal 3. Patients in group 3 receive the placebo medicine (powdered extract), used in the same way as with group 1 and 2 The total duration of all arms is 11 weeks. Timepoints are as follows: Visit 1: screening Visit 2: treatment initiation, participants will receive bojungikgitang, banhabaekchulchonmatang, or a placebo-drug for 8 weeks Visit 3: 4 weeks later of first medication, follow-up Visit 4: 8 weeks later of first medication, follow-up and treatment finish Visit 5: 10 weeks later of first medication, follow-up
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Bojungikgitang, banhabaekchulchonmatang
Primary outcome measure	Efficacy: Tinnitus Handicap Inventory (THI): the purpose of this questionnaire is to identify difficulties that may be experienced because of tinnitus: 1.1. F: Functional subscale (11 factors) 1.2. E: Emotional subscale (9 factors) 1.3. C: Catastrophic subscale (5 factors) Measured at baseline (1 week before treatment initiation), 4 weeks later of the first medication, 8 weeks later of the first medication, follow up (2 weeks later of treatment period) Safety: 1. Complete blood cell count, erythrocyte sedimentation rate (ESR) 2. Blood chemistry 3. Urine analysis 4. Chest antero-posterior (PA) film Measured at baseline, 8 weeks later of the first medication 5. Brain computed tomography (CT) 6. Otologic examination Measured at baseline 7. Vital signs; measured at baseline, treatment initiation, 4 weeks later of the first medication, 8 weeks later of the first medication
Secondary outcome measures	Efficacy: 1. Acoustic Examination (AE) 2. Visual Analogue Scale (VAS) Measured at baseline (1 week before treatment initiation), 4 weeks later of the first medication, 8 weeks later of the first medication, follow up (2 weeks later of treatment period) 3. EQ-5D 4. Health Utilities Index Mark 3 (HUI3) Measured at baseline, 8 weeks later of the first medication, follow up
Overall study start date	01/03/2009
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	120
Key inclusion criteria	1. Age greater than 19 years, either sex 2. Typical conditions of intermittent or continuous tinnitus 2.1. The duration of more than 3 months 2.2. Involuntary perception of the concept of a sound without the presence of an external source 3. Agreed not to receive another treatment during the clinical trial period 4. Written and informed consent
Key exclusion criteria	1. Receiving other forms of tinnitus treatments 2. Underlying disease or history: 2.1. Otitis media 2.2. Acoustic tumour 2.3. Intracranial lesion 2.4. Inner ear malformation 2.5. Head trauma 2.6. Ototoxic drug medication, etc. 3. Women in pregnacy and lactation or without contraception 4. Other clinical trial within the last 1 month 5. Auditory surgery, a major surgery or a blood transfusion within the last 1 month 6. Hypersensitiveness or allergy of drugs 7. Disease which can affect the absorption of drugs or disordered digestion after surgery related to the disease 8. History of neuropsychitric abnormality: 8.1. Manic-depression 8.2. Schizophrenia 8.3. Alcoholism 8.4. Drug addiction, etc. 9. Cannot understand a written consent or follow this study: 9.1. Mental retardation 9.2. Mental or emotional problems 10. Judged by expert that they are inappropriate to participate in this study
Date of first enrolment	01/03/2009
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

Korea, South

Study participating centre

Wonkwang University Oriental Medical Center

Gunpo
435-040
Korea, South

Sponsor information

Korea Health Industry Development Institute (KHIDI) (South Korea)
Research organisation

57-1 Noryangjin-dong
Dongjak-gu
Seoul
158-800
Korea, South

Phone	+82 (0)2 2194 7227
Email	withingrace@khidi.or.kr
Website	http://eng.khidi.or.kr/
"ROR"	https://ror.org/00fdzyk40

Funders

Funder type

Research organisation

Korea Health Industry Development Institute (KHIDI) (South Korea) - The 2008 Traditional Korean Medicine Research and Development Project

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	28/03/2010		Yes	No