Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Standard treatment combined with Yiyuancong, Standard treatment.
- Кому может быть актуально
- Состояния в реестре: Sudden Hearing Loss, Sensorineural Hearing Loss. Базовые параметры: 18 лет — 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss: A Multicenter, Randomized, Controlled Trial
Обзор
This project aims to evaluate the clinical efficacy of Yiyuancong, an independently developed traditional Chinese medicine (TCM) formula based on the homology of medicine and food, in participants with sudden sensorineural hearing loss (SSNHL) and to elucidate its potential underlying mechanisms. This study is designed as a multicenter, randomized controlled trial (RCT), utilizing dynamic randomization for participant allocation. Due to the requirement for the experimental group to continuously administer the TCM preparation for 1-2 months, this study is conducted as an open-label (non-blinded) trial. All participants will undergo audiological evaluations at baseline, day 7 of treatment, and upon completion of the first and second treatment courses. Based on previous research regarding integrated traditional Chinese and Western medicine for SSNHL, the estimated effect size (ES) for the improvement of pure-tone thresholds compared with Western medicine alone ranges from 0.5 to 0.8. Assuming an effect size of 0.5 for the difference in pure-tone audiometry (PTA) improvement between the experimental and control groups, with a significance level (α) of 0.05 (one-tailed) and a statistical power (1-β) of 0.8, the required sample size calculated via G\*Power software is 51 per group. Accounting for a 20% dropout rate, the investigators plan to enroll 64 participants per group (total N = 128).
Вмешательства
- Препарат Standard treatment combined with Yiyuancong
Standard treatment combined with 15 mL of Yiyuancong herbal paste, taken twice daily after meals - Препарат Standard treatment
Standard treatment
Первичные конечные точки
- Change in Pure-Tone Audiometry Hearing Threshold (dB HL) [Срок оценки: baseline (day of enrollment), and Day 7, Month 1, and Month 2 post-treatment.]
Вторичные конечные точки (6)
- Speech Recognition Score (Word Recognition Percentage) [Срок оценки: baseline, and Day 7, Month 1, and Month 2 post-treatment.]
- complete blood count (CBC) [Срок оценки: baseline, and Day 7, Month 1, and Month 2 post-treatment.]
- Haematological index on kidney function [Срок оценки: baseline, Month 1, and Month 2 post-treatment.]
- Haematological index on liver function [Срок оценки: baseline, Month 1, and Month 2 post-treatment.]
- Fecal composition analysis [Срок оценки: baseline, and Month 2 post-treatment.]
- Peripheral venous blood composition analysis [Срок оценки: Baseline, Month 1 and Month 2 post-treatment]
Критерии участия
Критерии включения
- Unilateral sudden sensorineural hearing loss (SSNHL) occurring within 72 hours, with a hearing threshold decrease of 20 dB at at least two consecutive frequencies.
- Enrollment must be completed within 14 days of the onset of SSNHL.
- Males or females aged 18 to 60 years.
- Ability to understand the study protocol and comply with regular follow-up visits.
Критерии исключения
- Pregnancy or lactation (breastfeeding).
- History of chronic ear disease, prior ear surgery, autoimmune hearing loss, or a confirmed diagnosis of Meniere's disease.
- Receipt of corticosteroid therapy for any reason within the previous 30 days.
- Presence of autoimmune diseases or chronic inflammatory diseases.
- Severe hepatic or renal impairment.
- Any other condition that, in the opinion of the investigator, renders the participant unsuitable for inclusion.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 5 центров
- Guangdong Provincial People's Hospital — Гуанчжоу
- Shenzhen Baoan People's Hospital — Шэньчжэнь
- Xiaolan People's Hospital of Zhongshan — Zhongshan
- Liuzhou Worker's Hospital — Liuzhou
- Guangdong Provincial People's Hospital Ganzhou Hospital — Ganzhou
Идентификаторы
NCT: NCT07505667 · KY2026-115-01