Efficacy and Safety for the Combination of Alpha Lipoic Acid, Gingko Biloba, Vitamin C, Zinc, Magnesium, Vitamin B6, Methylcobalamin, Vitamin E and Chromium Picolinate in the Patients of Sudden Sensorineural Hearing Loss and High Intensity Noise and Vibration Induced Hearing Loss: Post Marketing Surveillance Study

Introduction: Sudden sensorineural hearing loss (SSNHL) is defined as sensorineural hearing loss of 30 dB or more over 3 contiguous audiometric frequencies occurring over 72hrs. Conventionally the SSNHL is treated by corticosteroids but it is considered that, addition of antioxidants to the treatment can increase the percentage of patients with the complete recovery. So, this study was conducted to test the efficacy and safety for the combination of Alpha lipoic acid, Gingko biloba, Vitamin C, Zinc, Magnesium, Vitamin B6, Methylcobalamin, Vitamin E and Chromium Picolinate for the treatment of SSNHL and high Intensity noise and vibration induced hearing loss as a concomitant therapy in addition to the standard medical management. Methodology: Out of total 225 enrolled, 208 patients completed the study. Efficacy and safety evaluation was done on day 7 and 14 considering the baseline visit at day 0. Efficacy assessment was done by hearing Impairment questionnaire and hearing related quality of Life. Results: Mean score obtained from hearing impairment questionnaire at day 0 was 19.59 which was reduced to 12.56 at day 7 and was further reduced to 7.70 at day 14. On Visit 1 the mean hearing related quality of life score was 5.24 which was increased to 6.4 at day 7 and was found to be further increased to 7.41 at day 14. Conclusion: The investigational product was efficacious and safe for the treatment of SSNHL and high Intensity noise and vibration induced hearing loss when given as a concomitant therapy to the standard medical management.

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The efficacy and safety of systemic injection of Ginkgo biloba extract, EGb761, in idiopathic sudden sensorineural hearing loss: a randomized placebo-controlled clinical trial

European Archives of Oto-Rhino-Laryngology ◽

10.1007/s00405-015-3821-4 ◽

2015 ◽

Vol 273 (9) ◽

pp. 2433-2441 ◽

Cited By ~ 11

Author(s):

Ja-Won Koo ◽

Mun Young Chang ◽

Sung-Cheol Yun ◽

Tae Su Kim ◽

Soo-Keun Kong ◽

...

Keyword(s):

Clinical Trial ◽

Hearing Loss ◽

Sensorineural Hearing Loss ◽

Ginkgo Biloba ◽

Ginkgo Biloba Extract ◽

Sudden Sensorineural Hearing Loss ◽

Sensorineural Hearing ◽

Controlled Clinical Trial ◽

Efficacy And Safety ◽

Systemic Injection

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PATHOLOGICAL CHANGES IN THE INNER EAR IN EXPERIMENTAL MODELING OF SENSORINEURAL HEARING LOSS IN ANIMALS

Kuban Scientific Medical Bulletin ◽

10.25207/1608-6228-2018-25-3-82-87 ◽

2018 ◽

Vol 25 (3) ◽

pp. 82-87 ◽

Cited By ~ 1

Author(s):

V. G. OVSYANNIKOV ◽

T. V. ZOLOTOVA ◽

E. V. LOBZINA ◽

N. V. DUBINSKAYA

Keyword(s):

Hearing Loss ◽

Sensorineural Hearing Loss ◽

Inner Ear ◽

Broadband Noise ◽

Sensorineural Hearing ◽

Laboratory Animals ◽

Pathological Changes ◽

Noise And Vibration ◽

Noise Vibration ◽

Temporal Bones

Aim. Study of pathological changes in the inner ear in the modeling of sensorineural hearing loss in laboratory animals.Materials and methods. A pilot study involving 27 laboratory animals − white outbred rats – was conducted. Modeling of sensorineural hearing loss was conducted by exposing them for 10 days to broadband noise of 90 dB, vibration and simultaneous immobilization of laboratory animals divided into 3 groups according to exposure conditions. The development of hearing loss was confirmed by the results of the registration of delayed caused emissions and emissions at the frequency of distortion products. After removing rats from the experiment histological medication from animals cochlear was produced and they were studied by the method of light microscopy.Results. In animals exposed to noise and vibration effects on the background of immobilization, the formation of persistent sensorineural hearing loss was achieved, which was confirmed by objective registration of violations of auditory function, and also by the results of morphological study of cochlear of the temporal bones of animals. More pronounced histological changes were noted in animals exposed to noise and vibration on the background of immobilization compared with the group of rats which were exposed only to noise impact and immobilization without applying vibration. Dystrophic and destructive changes in the structures of the spiral organ, signs of apoptotic way of cell death in the inner ear were detected. In addition, pronounced changes occurred in the spiral ganglia.Conclusion. Modeling of sensorineural hearing loss in laboratory animals on the basis of noise and vibration exposure in terms of immobilization leads to the formation of persistent sensorineural hearing loss, as evidenced by functional and morphological methods. Pathological changes in the inner ear show themselves through dystrophic and destructive changes in the spiral organ, including apoptosis of cells, and especially in the spiral ganglia. The use of this noise-vibration model of hearing loss can be a promising basis for future studies of drugs for the treatment of sensorineural hearing loss.

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Safety and Efficacy for the Combination of Alpha Lipoic Acid, Gingko Biloba, Vitamin C, Zinc, Magnesium, Vitamin B6, Methylcobalamin, Vitamin E and Chromium Picolinate for the Medical Management of Age Related Hearing Loss: Post Marketing Surveillance Study

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol06-i07/1162 ◽

2021 ◽

Vol 6 (07) ◽

pp. 446-450

Author(s):

Dr. Mayuresh Kiran ◽

Mr. Lalit Pawaskar ◽

Ms. Shaheen Sheikh ◽

Ms. Pramita Waghambare

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Vitamin B6 ◽

Chromium Picolinate ◽

Life Score ◽

Gingko Biloba ◽

Age Related ◽

Related Quality ◽

Age Related Hearing Loss

Introduction: Age related hearing loss is defined as a bilateral, progressive, symmetrical age-related sensorineural hearing loss, which is most pronounced at the higher frequencies. It is considered that oxidative stress has a central role in the pathology of age-related hearing loss so, this study was conducted to test the efficacy and safety for the combination of antioxidants for the treatment of age-related hearing loss. Methodology: This was a multi-centric study conducted at 11 clinical trial sites. Out of total 176 enrolled, 160 trial subjects completed the study. For efficacy assessment, 2 parameters were used including hearing related quality of life score and score obtained from hearing impairment questionnaire on day 0 (visit 1), 45 (visit 2) and 90 (visit 3). Results: At visit 1, the mean hearing related quality of life score was 4.437 increased to 5.725 at visit 2 and further increased to 6.906 at visit 3. At visit 2 and 3, the increase in hearing related quality of life score was 29.028% and 55.645% respectively as compared to baseline. The score obtained from hearing impairment questionnaire was 25.581 at visit 1 reduced to 16.200 and further reduced to 9.943 at visit 3. Conclusion: The combination of Alpha lipoic acid, Gingko biloba, Vitamin C, Zinc, Magnesium, Vitamin B6, Methyl cobalamin, Vitamin E and Chromium Picolinate can be used for the medical management of age related hearing loss.

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