Long COVID FatiguePhase 4Shengmai LOFTNCT06980636
A Trial of Shengmai Liquid for Long COVID Fatigue.
A Phase 4 study testing Shengmai Liquid in people with Long COVID Fatigue, run by Beijing University of Chinese Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Long COVID Fatigue
- What is being tested?
- Shengmai Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 30 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Di Tan Hospital, , Capital Medical University
Beijing, China, 102488
Yanli Xu, +8613146214596, xuyanlii@126.com
About this study
Official title: Shengmai Liquid for Long COVID Fatigue: a Randomized Placebo-controlled 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.
Read more
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.
- Conditions
- Long COVID Fatigue
- Being tested
- Shengmai Liquid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shengmai LiquidDrug
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
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Shengmai Liquid | Experimental | For patients with Long COVID characterized by persistent fatigue who meet the inclusion and exclusion criteria, 100 patients will be randomly divided into a Shengmaiyin treatment group and a placebo control group using a random method. 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 Receives: Drug: Shengmai Liquid |
| Placebo | Placebo comparator | The placebo group will be given 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of improvement in patient fatigue, measured using the Modified Fatigue Impact Scale (MFIS)
MFIS is a standardized questionnaire reflecting physical and mental fatigue, consisting of 21 questions. Each question has five options (none at all, a little, sometimes, often, almost always), with a total score range of 0 to 84. The higher the score, the higher the degree of chronic fatigue.
Measured: From enrollment to the end of follow up at 12 weeks
Secondary outcomes (6)
Traditional Chinese Medicine Syndrome Score Scale
Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.
Measured: From enrollment to the end of treatment at 8 week
Improvement in depression, assessed using the 17-item Hamilton Depression Scale
Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.
Measured: From enrollment to the end of treatment at 8 weeks
Improvement in anxiety, assessed using the Hamilton Anxiety Scale (HAMA)
Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.
Measured: From enrollment to the end of treatment at 8 weeks
Improvement in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)
Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.
Measured: 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
measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.
Measured: From enrollment to the end of treatment at 8 weeks
six minute walk test（6MWT）
Measured once during the screening period before the start of the trial, and then at 30 days and 60 days during the trial, for a total of three measurements.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Dec 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Chemistry - Vietnam Academy of Science and Technology, Beijing Ditan Hospital
- Responsible party
- Principal investigator, Huijuan Cao, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980636
- Sponsor's protocol ID
- 2023YFE0198400
- Other IDs
- 2023YFE0198400
- Acronym
- Shengmai LOFT
- Status last verified
- Jun 2025
- First submitted
- 18 May 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shengmai Liquid for Long COVID Fatigue: a Randomized Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT06980636
- Acronym / sponsor ID
- Shengmai LOFT / 2023YFE0198400
- Conditions
- Long COVID Fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Institute of Chemistry - Vietnam Academy of Science and Technology, Beijing Ditan Hospital
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shengmai Liquid | Experimental | Drug: Shengmai LiquidFor patients with Long COVID characterized by persistent fatigue who meet the inclusion and exclusion criteria, 100 patients will be randomly divided into a Shengmaiyin treatment group and a placebo control group using a random method. 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 |
| Placebo | Placebo comparator | Other: PlaceboThe placebo group will be given 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shengmai LiquidThe 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 | Drug | Shengmai Liquid |
| PlaceboA 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. | Other | Placebo |
Primary outcome
The degree of improvement in patient fatigue, measured using the Modified Fatigue Impact Scale (MFIS)
Time frame: From enrollment to the end of follow up at 12 weeks
MFIS is a standardized questionnaire reflecting physical and mental fatigue, consisting of 21 questions. Each question has five options (none at all, a little, sometimes, often, almost always), with a total score range of 0 to 84. The higher the score, the higher the degree of chronic fatigue.
6 secondary outcomes
Traditional Chinese Medicine Syndrome Score Scale
Time frame: From enrollment to the end of treatment at 8 week
Improvement in depression, assessed using the 17-item Hamilton Depression Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Improvement in anxiety, assessed using the Hamilton Anxiety Scale (HAMA)
Time frame: From enrollment to the end of treatment at 8 weeks
Improvement in sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Time frame: From enrollment to the end of treatment at 8 weeks
six minute walk test（6MWT）
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shengmai Liquid in people with Long COVID Fatigue, run by Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huijuan Cao, Professor (0086 +13466615885, huijuancao327@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of improvement in patient fatigue, measured using the Modified Fatigue Impact Scale (MFIS) (time frame: From enrollment to the end of follow up at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.