A Trial of Shengmai Liquid for Long COVID Fatigue.

Launched by BEIJING UNIVERSITY OF CHINESE MEDICINE · May 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a liquid treatment called Shengmai to see if it can help reduce fatigue in people suffering from Long COVID. The researchers want to find out if Shengmai can make participants feel less tired, improve their sleep, and also help with feelings of anxiety and depression. Participants in the trial will take either Shengmai or a placebo (a dummy treatment with no active ingredients) every day for 8 weeks. They will also have regular check-ups at the clinic and two follow-up phone calls after the treatment ends to track their progress.

To join the trial, you need to be between 18 and 75 years old and have been diagnosed with Long COVID fatigue. However, certain medical conditions, like serious heart, liver, or kidney problems, would exclude you from participation. Overall, this study aims to provide more information about the safety and effectiveness of Shengmai in helping those affected by Long COVID fatigue. If you decide to participate, you'll be helping researchers learn more about this condition and potential treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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