Contact information
Type
Scientific
Primary contact
Dr Donghyo Lee
ORCID ID
Contact details
Wonkwang University Oriental Medical Center
1126-1 Sanbon-dong
Gunpo
435-040
Korea
South
secretop17@naver.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
B08-0045-AM0829-08N1-00010A
Study information
Scientific title
A clinical study of bojungikgitang and banhabaekchulchonmatang in adult tinnitus patients: a randomised, double-blind, three-arm, placebo-controlled trial
Acronym
Study hypothesis
This study is aimed to evaluate the efficacy and safety of bojungikgitang and banhabaekchulchonmatang in adult tinnitus patients.
Ethics approval
Wonkwang University Oriental Medical Center Ethics Committee gave approval on the 25th February 2009
Study design
Randomised phase III double-blind three-arm placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
01/03/2009
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/03/2009
Recruitment end date
30/09/2009
Locations
Countries of recruitment
Korea, South
Trial participating centre
Wonkwang University Oriental Medical Center
Gunpo
435-040
Korea, South
Sponsor information
Organisation
Korea Health Industry Development Institute (KHIDI) (South Korea)
Sponsor details
57-1 Noryangjin-dong
Dongjak-gu
Seoul
158-800
Korea
South
+82 (0)2 2194 7227
withingrace@khidi.or.kr
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Korea Health Industry Development Institute (KHIDI) (South Korea) - The 2008 Traditional Korean Medicine Research and Development Project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20346181
Publication citations
-
Protocol
Kim NK, Lee DH, Lee JH, Oh YL, Yoon IH, Seo ES, Lee CH, Bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus, a randomized, double-blind, three-arm, placebo-controlled trial--study protocol., Trials, 2010, 11, 34, doi: 10.1186/1745-6215-11-34.