A Trial of Shengmai Liquid for Long COVID Fatigue.

Официальное название

Shengmai Liquid for Long COVID Fatigue: a Randomized Placebo-controlled Trial.

Обзор

The goal of this clinical trial is to learn if Shengmai liquid works to treat Long Covid fatigue. It will also learn about the safety of Shengmai liquid. The main questions it aims to answer are: * Dose the Shengmai liquid will reduce the level of fatigue in the participants and reduce the fatigue scale score of the participants? * Dose the Shengmai liquid will reduce the level of anxiety and depression in the participants and improve the sleep quality and quality of life of the participants Researchers will compare Shengmai oral liquid to a placebo (a look-alike substance that contains no drug) to see if Shengmai liquid works to treat Long Covid fatigue. Participants will: * Take Shengmai liquid or a placebo every day for 8 weeks. * Visit the clinic once every 4 weeks for check up and test. There are a total of two telephone follow-ups, one follow-up 15 days after the treatment starts and another follow-up 30 days after the treatment ends. * Participants' medication responses and scale scores will be recorded.

Вмешательства

• Препарат Shengmai Liquid
  The Shengmaiyin treatment group will be given the traditional Chinese medicine Shengmaiyin oral liquid (produced by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with the approval number Z41021384. Ingredients: Codonopsis pilosula, Ophiopogon japonicus, Schisandra chinensis, excipients: sucrose, sodium benzoate, ethylparaben, specification 10m1/bottle), taken orally at a dose of 10ml per time, three times a day
• Другое Placebo
  A simulated Shengmaiyin oral liquid (provided by Jilin Aodong Yanbian Pharmaceutical Co., Ltd., with main ingredients water, brown sugar, flavoring agents, etc., specification 10m/bottle), 10ml per time, three times a day. The treatment course for Shengmaiyin or placebo will be 8 weeks (56 days), with follow-up continuing until 30 days after the end of the treatment course.

Первичные конечные точки

• The degree of improvement in patient fatigue, measured using the Modified Fatigue Impact Scale (MFIS) [Срок оценки: From enrollment to the end of follow up at 12 weeks]

Вторичные конечные точки (6)

• Traditional Chinese Medicine Syndrome Score Scale [Срок оценки: From enrollment to the end of treatment at 8 week]
• Improvement in depression, assessed using the 17-item Hamilton Depression Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Improvement in anxiety, assessed using the Hamilton Anxiety Scale (HAMA) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Improvement in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: From enrollment to the end of treatment at 8 week]
• Improvement in quality of life, assessed using the World Health Organization Quality of Life Scale [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• six minute walk test（6MWT） [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• Aged between 18 and 75 years;
• Meet the above diagnostic criteria;
• Meet the traditional Chinese medicine syndrome diagnostic criteria;
• Consent and sign the informed consent form

Критерии исключения

• Currently in need of or expected to require high-flow oxygen therapy, positive pressure ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) and other advanced respiratory support measures;
• Have a known history of active liver disease (excluding non-alcoholic fatty liver changes), including active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh class B or C liver function impairment, or acute liver failure. Liver function at screening shows any of the following: serum alanine aminotransferase (ALT) >3× the upper limit of normal (ULN); serum aspartate aminotransferase (AST) >3×ULN; serum bilirubin >2×ULN;
• Undergoing dialysis treatment, or known to have moderate to severe renal impairment (i.e., an estimated glomerular filtration rate (eGFR) value calculated based on serum creatinine using the CKD-EPI formula ≤45 mL/min/1.73 m² within 6 months before screening);
• Moderate to severe congestive heart failure within 6 months before screening (according to the New York Heart Association classification criteria, with cardiac function class III or IV), experienced a stroke, myocardial infarction, or coronary artery stent implantation; or have uncontrolled hypertension (defined as systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg, with relevant records). Significant or clinically relevant electrocardiogram abnormalities, such as second-degree type II atrioventricular block, left bundle branch block, etc.;
• Suffered from influenza A, influenza B, or other infectious diseases within 3 months before screening;
• Have/ever had severe neurological diseases (epilepsy, convulsions, or seizures) or mental illness, or have a family history of mental illness;
• Pregnant or breastfeeding. Women who are breastfeeding or have a positive pregnancy test before taking the medication;
• History of malignant tumors within 5 years before screening, with existing and progressing tumors, and patients who are expected to need treatment during the study period;
• Have chronic fatigue syndrome or autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.);
• Known allergy to any component of the study drug;
• Diseases judged by the investigator to be unsuitable for participation in this study;
• Taken traditional Chinese medicine containing Codonopsis pilosula, Ophiopogon japonicus, Schisandra chinensis, or Astragalus membranaceus within 2 weeks before screening;
• Participating in other drug or medical device-related studies at the same time

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Di Tan Hospital, , Capital Medical University — Пекин

Идентификаторы

NCT: NCT06980636 · 2023YFE0198400 · 2023YFE0198400

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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