Effects of Huperzine a on Presbycusis(Δ,kHz, DB,MMSE, AD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2030-09-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Presbycusis Tinnitus Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The studies were divided into 2 groups: Control subgroup and huperzine A group.The study is a single-center, randomized, basic treatment and health education controlled trial, with minimized allocation of patients to one of the two groups.

For the study of tinnitus intervention, there is a 3 to 12 month follow-up.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Huperzine A intervention

Huperzine A intervention: Huperzine A with a dose 0.1\~0.2 mg/time, 2 times/day. BTHE：basic treatment and health education

Group Type EXPERIMENTAL

BTHE and Huperzine A

Intervention Type DRUG

huperzine A intervention

BETH

Intervention Type OTHER

basic treatment and health education

control

Participants in the BTHE group will receive advice regarding lifestyle modification, avoiding alcohol and cigarette consumption.

Group Type SHAM_COMPARATOR

BTHE and Huperzine A

Intervention Type DRUG

huperzine A intervention

BETH

Intervention Type OTHER

basic treatment and health education

Interventions

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BTHE and Huperzine A

huperzine A intervention

Intervention Type DRUG

BETH

basic treatment and health education

Intervention Type OTHER

Other Intervention Names

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acetylcholinesterase inhibitor

Eligibility Criteria

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Inclusion Criteria

(1) 60 to 85 years old; (2) Mild-to-moderate sensorineural hearing loss (the pure tone averaged across octave frequencies between 0.25 to 4kHz of 26-70 dB HL), with subjective tinnitus, subjective cognitive decline or mild cognitive impairment; (3) Able to tolerate huperzine A treatment; (4) more than 3 months' experience of constant tinnitus; (5) Tinnitus Handicap Inventory score values \>10; (6) No participation in any other clinical trial in the past 3 months; (7) Able to accomplish relevant tests and follow-up.

Exclusion Criteria

(1) Conductive hearing loss; (2) current (3+ months) hearing aid(s) user; (3) Dependence due to poor physical activity; (4) Allergic to huperzine A; (5) History of malignancy within 5 years or other serious medical conditions before screening, including severe bradycardia, hypotension, angina, asthma, ileus, renal insufficiency, neurological diseases (e.g. epilepsy), psychiatric disorder (e.g. schizophrenia, severe depression and anxiety); (6) Acute brain trauma and stroke within 2 weeks; (7) history of general pain disorder and the use of pain relief drugs on a regular basis; (8) Patients who have started treatment or made changes in treatment with drugs known to influence tinnitus within 6 weeks before investigation starts. (9) Individuals simultaneously or previously (within 30 days prior to investigation start) participate in a clinical investigation using experimental drugs or devices. (10) Ongoing serious life event; (11) Vision impairment.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Zhijun Bao

Huadong hospital, Fudan University, Clinical professor of Otolaryngology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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zhuowei yu, MD

Role: STUDY_DIRECTOR

Shanghai Institute of Geriatrics and Gerontology, Shanghai Key Laboratory of Clinical Geriatrics, Huadong Hospital, and Research Center of Aging and Medicine, Shanghai Medical College, Fudan University, Shanghai 200040, China.