Condition category
Ear, Nose and Throat
Date applied
25/05/2009
Date assigned
05/06/2009
Last edited
29/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://eng.khidi.or.kr/

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

Results - basic reporting

Publication summary

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20346181

Publication citations

  1. 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.

Additional files

Editorial Notes