دورية أكاديمية
Evaluation of Renessans (Iodine Complex Molecule) Safety in Human Beings: An Open-Labeled Clinical Study
العنوان: | Evaluation of Renessans (Iodine Complex Molecule) Safety in Human Beings: An Open-Labeled Clinical Study |
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المؤلفون: | Ahmad Kamal, Asif Mahmood, Muhammad Zaman, Muhammad Farooq, Bilal Nasir, Nasir Islam, Rai Muhammad Sarfraz, Nadiah Zafar, Ghulam Murtaza, Abdul-Basit Raheel, Areeba Shahid, Zahra Abid, Sajjad Ahmed |
المصدر: | Dose-Response, Vol 20 (2022) |
بيانات النشر: | SAGE Publishing, 2022. |
سنة النشر: | 2022 |
المجموعة: | LCC:Therapeutics. Pharmacology |
مصطلحات موضوعية: | Therapeutics. Pharmacology, RM1-950 |
الوصف: | Extensive studies on evaluation of effectiveness/toxicity of different oral doses of iodine have not been explored yet. An open-labeled phase I clinical studies were conducted using iodine complex based research compound called Renessans. Study groups were observed for development of any adverse/serious adverse events and alteration in laboratory values of vital organs, TSH and T4 hormones before and after the administration of the products. Out of 31 consented individuals, 24 healthy individuals participated in the study. Rate of occurrence of mild Adverse Events (AEs) in group A was 8.3% while in Group B it was 33.33% but these Adverse Events were self-resolving. After completion of study treatment blood serum iodine was reported to 3522.88 µg/l while mean urine iodine concentration (MUIC) was greater than 2000 µg/l. Hormonal and vital organ’s testing revealed that all parameters of TSH and T4, LFT, CBC, RFT remained unaltered except from ALT-SGPT ( P-value = .006) and AST-SGOT ( P-value = .02). From all of these findings, it can be inferred that the use of Renessans formulations did not pose any sort of risk to human body and can be considered safe through this pilot study. |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 1559-3258 15593258 |
Relation: | https://doaj.org/toc/1559-3258 |
DOI: | 10.1177/15593258221129777 |
URL الوصول: | https://doaj.org/article/f6f5fefc0a3b4079b3619d316bebe13e |
رقم الأكسشن: | edsdoj.f6f5fefc0a3b4079b3619d316bebe13e |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 15593258 |
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DOI: | 10.1177/15593258221129777 |