Official Title
Shengmai Liquid for Long COVID Fatigue: a Randomized Placebo-controlled Trial.
Brief Summary

The goal of this clinical trial is to learn if Shengmai liquid works to treat Long Covidfatigue. It will also learn about the safety of Shengmai liquid. The main questions itaims 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.

Detailed Description

Not Provided

Not yet recruiting
Long COVID Fatigue

Drug: 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

Other: 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.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Locations

Not Provided

Contacts

Huijuan Cao, Professor
0086 +13466615885
huijuancao327@hotmail.com

Not Provided

Beijing University of Chinese Medicine
NCT Number
MeSH Terms
Post-Acute COVID-19 Syndrome
Fatigue