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

Phase 1

Recruiting

• Conditions: Chronic Subjective Tinnitus

• Registration Number: ITMCTR2200005486
• Lead Sponsor: School of Chinese Medicine, the Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified