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Клиническое исследование

A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients

NCT: NCT07563790 · COMPLETED

NCT IDNCT07563790
СтатусCOMPLETED
Дата начала2024-07-24
Завершение2025-08-08

Краткое описание

This study involves a medical device in the form of syrup, not yet on the market and tested for the first time in humans, named "FIBROIN SYRUP". The intended use is to reduce the GastroEsophageal Reflux Disease (GERD) symptoms such as heartburn, epigastric pain, irritative and nocturnal cough, dysphagia and dysphonia, which may occur especially after meals or during the night due to lying position. "FIBROIN SYRUP" has never been tested on humans and this study aims to evaluate the safety, tolerability and efficacy of the medical device when taken after the main meals (breakfast, lunch, and dinner; total: 3 sticks/day) for 6 weeks.

Официальный источник

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Данные получены через API ClinicalTrials.gov. Актуальный статус смотрите в официальной записи.

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