A Trial of Shengmai Liquid for Long COVID Fatigue.

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing University of Chinese Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.;

Trial design

Treatments tested in this trial

  • Shengmai Liquid
  • Placebo

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Beijing University of Chinese Medicine

Lead sponsor

Institute of Chemistry - Vietnam Academy of Science and Technology

Collaborator

Beijing Ditan Hospital

Collaborator