Shengmai oral liquid for Long COVID fatigue

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

This test will see if taking Shengmai oral liquid every day for 8 weeks helps adults (18–75) with Long COVID fatigue feel less tired and have better mood, sleep, and quality of life.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beijing University of Chinese Medicine (Academic / other)
• Locations: 1 site (Beijing, China)
• Trial ID: NCT06980636 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study compares daily Shengmai oral liquid with a matching placebo in adults who have Long COVID fatigue. Participants take the assigned liquid for 8 weeks and attend clinic visits every four weeks, with telephone follow-ups 15 days after starting and 30 days after finishing treatment. Researchers will measure changes in fatigue scale scores and secondary outcomes including anxiety, depression, sleep quality, and overall quality of life while monitoring safety and organ function. Enrollment follows both diagnostic criteria for Long COVID fatigue and traditional Chinese medicine syndrome criteria and is conducted at Beijing clinical sites.

Who should consider this trial

Good fit: Adults aged 18–75 with Long COVID fatigue who meet the trial's diagnostic and traditional Chinese medicine syndrome criteria and can attend clinic visits in Beijing are the intended participants.

Not a fit: People with severe liver or kidney disease, those on dialysis, or those needing advanced respiratory support are excluded and are unlikely to benefit from this intervention in the trial.

Why it matters

Potential benefit: If effective, Shengmai liquid could provide a well-tolerated oral option to reduce fatigue and improve mood, sleep, and daily functioning for people with Long COVID.

How similar studies have performed: Shengmai formulations have been used historically and in small studies for fatigue and cardiac conditions, but their use specifically for Long COVID fatigue has not been established in rigorous randomized trials.

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

Where this trial is running

Beijing, China

• Beijing Di Tan Hospital, , Capital Medical University — Beijing, China, China (Recruiting)

Study contacts

• Study coordinator: Huijuan Cao, Professor

Conditions Long COVID Fatigue