To investigate the effects of huperzine A on tinnitus suppression, hearing and cognitive function protection in patients with presbycusis-related subjective tinnitus and cognitive impairment.
This study is a randomized, controlled trial. 60 eligible participants in total will be recruited. Participants in each group will be evenly and randomly assigned to the huperzine A subgroup and control subgroup using simple randomization method. Participants in the treatment subgroup will receive huperzine A (a dose of 0.2 mg/time, 2 times/day) with basic treatment and health education(BTHE), and those in the control subgroup will receive BTHE only. The primary outcome (auditory function) and secondary outcomes (tinnitus, cognitive symptom and quality of life) will be evaluated at baseline, 3-, 6-, 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
huperzine A intervention
basic treatment and health education
Huadong Hospital
Shanghai, Shanghai Municipality, China
hearing function protection
All participants (including with tinnitus and without tinnitus) will report in the measure. Δ value of averaged hearing threshold = re-test threshold - initial threshold, Δ value of averaged hearing threshold ≤ 0 showed good responders, and \> 0 showed poor responders.
Time frame: 1 years
global cognitive function protection
All participants (including with tinnitus and without tinnitus) will report in the outcome measure. ΔMMSE = re-test MMSE - initial MMSE, ΔMMSE\< 0 showed poor responders and hearing threshold ≤ 0 showed good responders; and \> 0 showed poor responders ΔMMSE≥ 0 showed good responders
Time frame: 1 years
special cognitive domains:orientation to time, orientation to place, registration, attention and calculations,recall, language,repetition and complex commands
MMSE scale in different domains (MMSE SCALE, 0-30)
Time frame: 1 years
Tinnitus suppression
150 participants with tinnitus will report in the outcome measure. Method 1: tinnitus functional index (0\~100,≤25,relatively mild tinnitus; 25\~50,significant problems with tinnitus; ≥50, tinnitus severe enough ). method 2:no effect on tinnitus was showed "0"; symptomatic alleviation was showed "1";and tinnitus disappear was showed "2"
Time frame: 1 years
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