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An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is one of the most widespread degenerative disorders in elderly people. A 90-day, open-label clinical study was conducted in 40 patients, aged 50 years or older, with early-stage dry-type AMD to evaluate the safety and efficacy of Macumax(®), a novel mixture of...

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Autores principales: Majeed, Muhammed, Majeed, Shaheen, Nagabhushanam, Kalyanam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8140349/
https://www.ncbi.nlm.nih.gov/pubmed/33180005
http://dx.doi.org/10.1089/jmf.2020.0097
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author Majeed, Muhammed
Majeed, Shaheen
Nagabhushanam, Kalyanam
author_facet Majeed, Muhammed
Majeed, Shaheen
Nagabhushanam, Kalyanam
author_sort Majeed, Muhammed
collection PubMed
description Age-related macular degeneration (AMD) is one of the most widespread degenerative disorders in elderly people. A 90-day, open-label clinical study was conducted in 40 patients, aged 50 years or older, with early-stage dry-type AMD to evaluate the safety and efficacy of Macumax(®), a novel mixture of a phyto-mineral nutritional supplement containing ZeaLutein(®) (consisting of lutein, zeaxanthin, and piperine), extracts of bilberry, saffron, and zinc monomethionine. Subjects received one capsule of the supplement twice daily for 90 days. The treatment measures included physical examination, vital signs, and assessment of subjective and objective symptoms at baseline and after treatment. For efficacy assessment, baseline values were compared with the values after treatment at 30-day intervals, on days 30, 60, and 90. The safety of the treatment was assessed during all the visits. Overall, the patients showed improvement in the subjective symptoms, such as vision scores after treatment compared with baseline. The changes in diminished and distorted vision scores were found to be significant from day 60 (P < .05). In the case of objective symptoms, only 40% of the subjects (P < .05) had abnormal Amsler's grid aberration scores on day 90 compared with 77.5% of subjects at the beginning of the study. No adverse events were observed during the study. This pilot study provides evidence that Macumax(®) supplementation is safe and maintained eye health without further progression of the disease in patients with early-stage dry-type AMD. Clinical Trial Registration number: CTRI/2016/02/006676
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spelling pubmed-81403492021-05-24 An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration Majeed, Muhammed Majeed, Shaheen Nagabhushanam, Kalyanam J Med Food Full Communications Age-related macular degeneration (AMD) is one of the most widespread degenerative disorders in elderly people. A 90-day, open-label clinical study was conducted in 40 patients, aged 50 years or older, with early-stage dry-type AMD to evaluate the safety and efficacy of Macumax(®), a novel mixture of a phyto-mineral nutritional supplement containing ZeaLutein(®) (consisting of lutein, zeaxanthin, and piperine), extracts of bilberry, saffron, and zinc monomethionine. Subjects received one capsule of the supplement twice daily for 90 days. The treatment measures included physical examination, vital signs, and assessment of subjective and objective symptoms at baseline and after treatment. For efficacy assessment, baseline values were compared with the values after treatment at 30-day intervals, on days 30, 60, and 90. The safety of the treatment was assessed during all the visits. Overall, the patients showed improvement in the subjective symptoms, such as vision scores after treatment compared with baseline. The changes in diminished and distorted vision scores were found to be significant from day 60 (P < .05). In the case of objective symptoms, only 40% of the subjects (P < .05) had abnormal Amsler's grid aberration scores on day 90 compared with 77.5% of subjects at the beginning of the study. No adverse events were observed during the study. This pilot study provides evidence that Macumax(®) supplementation is safe and maintained eye health without further progression of the disease in patients with early-stage dry-type AMD. Clinical Trial Registration number: CTRI/2016/02/006676 Mary Ann Liebert, Inc., publishers 2021-05-01 2021-05-17 /pmc/articles/PMC8140349/ /pubmed/33180005 http://dx.doi.org/10.1089/jmf.2020.0097 Text en © Muhammed Majeed et al. 2021; Published by Mary Ann Liebert, Inc. https://creativecommons.org/licenses/by/4.0/This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Full Communications
Majeed, Muhammed
Majeed, Shaheen
Nagabhushanam, Kalyanam
An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration
title An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration
title_full An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration
title_fullStr An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration
title_full_unstemmed An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration
title_short An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration
title_sort open-label pilot study on macumax supplementation for dry-type age-related macular degeneration
topic Full Communications
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8140349/
https://www.ncbi.nlm.nih.gov/pubmed/33180005
http://dx.doi.org/10.1089/jmf.2020.0097
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