None listed
Conditions
Interventions
Dietary Supplement : The product name of the test food is Cuscutae semen and Rehmanniae radix preparata complex extract, and the raw material name is Cuscutae semen and Rehmanniae radix preparata, and
Sponsors
Semyung University Oriental Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. men and women over the age of 40 2. Those with an average hearing threshold of 16 dBHL or more and 55 dBHL or less in either ear based on ASHA (1, 2, 3, 4 kHz) when evaluating PTA for both ears 3. Persons with sensory nerve hearing loss (the difference between airway hearing and bone degree hearing is less than 10 dB) 4. A person who voluntarily decides to participate and agrees in writing after hearing and understanding the detailed explanation of this human body application test
Exclusion criteria
Exclusion criteria: 1. A person who is allergic to test substances and has side effects 2. A person who has a history of chronic otitis media, recurrent otitis media, and perforation of the eardrum 3. A person currently being treated for acute inflammatory diseases (pneumonia, flu, upper respiratory tract infection), etc 4. a person with total hearing loss 5. A person who is taking drugs that affect the neuropsychiatric system, such as antidepressants and anti-anxiety drugs, due to neuropsychiatric disorders such as depression, anxiety, sleep disorders, and convulsive diseases 6. People with congenital hearing loss, hereditary hearing loss, and familial hearing loss 7. a person who has had surgery for hearing loss 8. A person who has received radiation therapy in which the temporal bone is included in the radiation treatment area 9. A person who has a skull fracture accompanied by a fracture or has been diagnosed by a medical institution with a wow concussion 10. a person who is unable to perform hearing tests 11. Pregnant women or lactating women and women of childbearing age who do not agree with the choice of appropriate contraceptive methods (or oral contraceptives, hormonal transplants, intrauterine instruments, condoms, and fertilizers) 12. Those with uncontrolled hypertension (160/100 mmHg or more) 13. People with uncontrolled diabetes (above 126 mg/dL per fasting blood sugar) 14. Those whose AST or ALT is more than three times the upper limit of the reference range 15. People with kidney disease or serum creatinine above 2.0 mg/dL 16. Those who have a history of cancer within five years or are currently being treated (excluding skin tumors other than melanoma) 17. Those diagnosed with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), cardiovascular disease (angina, myocardial infarction, heart failure, arrhythmia), and pulmonary disease (chronic obstructive pulmonary disease) within 3 months at the time of screening (but only clinically stable persons may participate in the study at the discretion of the examiner) 18. Those who have participated in other clinical trials within the last three months 19. A person who intends to participate in another clinical trial during this human application trial period 20. From the opinion of the person in charge of testing (or the person in charge of testing who has been delegated), a person who is deemed to be unable to comply with the compliance of the test or is deemed unfit to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Word Recognition Score in noise test: Signal-to-Noise Ratio 0 / Speech Reception Threshold +10 dBHL intensity after 4 (8 weeks) of visit compared to 2 (0 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Word Recognition Score in noise test: Signal-to-Noise Ratio 0 / Speech Reception Threshold +20 dBHL, +30 dBHL intensity after 4 (8 weeks) visits compared to 2 (0 weeks) Word Recognition Score in noise test;Word Recognition Score in quiet test: Speech Reception Threshold +10 dBHL, +20 dBHL, +30 dBHL intensity after visit 4 (8 weeks) compared to visit 2 (0 weeks);Average hearing threshold (dBHL) change at 1, 2, 3, 4 kHz intensity after 4 (8 weeks) of the visit compared to 2 (0 weeks) of the visit;After 4 (8 weeks) of the visit compared to 2 (0 weeks) of the visit, the change in dB from the minimum intensity at which the bill can be accurately heard by 50% during the draft hearing threshold test (SRT);Change in total score of KHHIE survey after visit 4 (8 weeks) compared to visit 2 (0 weeks);an abnormal reaction;Vital signs (blood pressure, pulse, body temperature);Body Measurements (Weight, Body Mass Index);Clinical pathology (blood biochemical, blood biochemical, urine test) | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong eun Lee
Semyung University Oriental Medicine Hospital
Outcome results
None listed