A Randomised Pilot Trial Evaluating a Chinese Medicine Formula in the Treatment of Chronic Subjective Tinnitus

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200005486

Enrollment

Unknown

Registered

2021-05-23

Start date

2021-06-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Subjective Tinnitus

Interventions

Experimental group:Chinese medicine formula plus informative counselling

Control group:Informative counselling

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) Diagnosis of unilateral or bilateral subjective continuous (24 hours) tinnitus with normal hearing or bilateral / unilateral mild to moderate hearing loss. i.e. an average pure-tone audiometry threshold for 500, 1000 and 2000 Hz between 0 dB HL and 55 dB HL; 2) Aged between 18 and 50 years old; 3) Tinnitus duration of at least 6 months; 4) Moderate level of distress caused by tinnitus with scores above 38 on the Chinese (Cantonese) version of the Tinnitus Handicap Inventory (THI-CH) [25-26]; 5) Having symptoms of low back pain or general fatigue, and dark or pale tongue, which are symptoms or signs of TCM syndrome of kidney essence deficiency and stagnation of Qi and blood flowing in the meridian.

Exclusion criteria

Exclusion criteria: 1) Has predisposing disease with tinnitus symptoms amenable to medical or surgical intervention; 2) Has diagnosis of pulsatile tinnitus, somatosounds, or objective tinnitus; 3) Has emotional, psychological, or psychiatric condition precluding full participation of the study; 4) Has ever received any clinical treatment for tinnitus within previous one month; 5) being pregnant, preparing for pregnancy or breast-feeding; 6) has ever taken any Chinese herbal medicine treatment in the previous one month; 7) has history of being allergy to Chinese herbal medicines; 8) Has ever taken any anti-coagulant or anti-platelet agents other than low dose (=81 mg per day) aspirin; 9) Has sever diabetes, hypertension or cardiac, liver, renal, cerebrovascular disease, or malignant diseases.

Design outcomes

Primary

Measure	Time frame
feasibility of a full-scale RCT;	—

Countries

China

Contacts

Public ContactZhang, Hongwei

The Chinese University of Hong Kong

zhanghw@cuhk.edu.hk+852-39439845

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026