Long COVIDPhase 2NCT05684952
The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue
A Phase 2 study testing Shenlingcao Oral Liquid in people with Long COVID, run by Hong Kong Baptist University at 1 site in China.
Trial summary
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID
- What is being tested?
- Shenlingcao Oral Liquid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 1 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years adults
- Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC)
- Chalder fatigue scale (0-11) not less than 4
Who cannot join
- Have any medical history that may cause fatigue before COVID-19 infection, which include but not limited to cardiovascular diseases, chronic lung diseases, dyspnea, cognitive diseases, psychological diseases, chronic liver or renal diseases, cancer, etc.
- Must chronically taking medicines that may affect the study results.
- Severe obesity (BMI not less than 45)
- Alcoholism or drug abuse
- Allergy to Chinese medicine
- Pregnancy, or plan to be pregnant, or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hong Kong Baptist University Chinese Medicine Clinic
Hong Kong
ZhaoXiang Bian, PhD, (852)3411 2905, bzxiang@hkbu.edu.hk
ZhaoXiang Bian, PhD
About this study
Official title: The Efficacy and Safety of a Chinese Herbal Medicine (Shenlingcao Oral Liquid) for Treating Long COVID Associated Fatigue：a Double-blinded, Placebo-controlled, Randomized Clinical Trial
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue.
Read the detailed description
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue. Our target population is adults (18-65 years old) with a COVID-19 infection history and have moderate to severe fatigue symptom at least 4 weeks after infection. The total sample size is 152. All participants will be randomly attributed to treatment group or placebo group in 1:1 ratio. The treatment duration is 4-week, and the follow-up period is also 4 weeks. Shenlingcao oral solution has been registered and marketed in mainland China, it is a safe product and pervious studies suggested it has anti-fatigue function. The primary efficacy outcome is the change of scores of Chalder fatigue scale (0-33 points) after 4-week treatment. The primary safety outcome is the number of adverse events. This study will be conducted in Hong Kong Baptist University Mr. \& Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre.
- Conditions
- Long COVID
- Being tested
- Shenlingcao Oral Liquid
- Keywords
- fatigue, Chinese herbal medicine
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenlingcao Oral LiquidDrug
Also called placebo of Shenlingcao Oral Liquid
Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subjects need to take the Chinese herbal medicine (Shenlingcao oral liquid) 200 ml twice per day for 4 weeks. Shenlingcao oral solution is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder. Receives: Drug: Shenlingcao Oral Liquid |
| Control group | Placebo comparator | Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks. Receives: Drug: Shenlingcao Oral Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.
Measured: 4 weeks
Secondary outcomes (8)
Insomnia: Change of scores in Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Measured: 4 weeks
Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health.
Measured: 4 weeks
Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)
HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression
Measured: 4 weeks
Muscle strength: Change of Hand Grip Strength (HGS)
Handgrip strength (HGS) is a simple and reliable measurement of maximum voluntary muscle strength. It is an important tool for diagnosing sarcopenia and is widely used as a single indicator to represent overall muscle strength
Measured: 4 weeks
Long Covid related symptoms
Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.
Measured: 4 weeks
Safety: number of adverse events
Assessed by number of adverse events or side effects
Measured: 4 weeks
Exploratory outcome: Immunology analysis
Assessed by the change of important immune index in serumImmune index
Measured: 4 weeks
Exploratory outcome: Gut microbiota analysis
Assessed by the change of gut microbiota composition and its metabolimics.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start30 May 2023
- Primary completion15 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded, placebo-controlled, randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangzhong Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684952
- Sponsor's protocol ID
- LongCov-fatigue CHM
- Status last verified
- Jun 2023
- First submitted
- 11 Jan 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a Chinese Herbal Medicine (Shenlingcao Oral Liquid) for Treating Long COVID Associated Fatigue：a Double-blinded, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05684952
- Acronym / sponsor ID
- LongCov-fatigue CHM
- Conditions
- Long COVID
- Keywords
- fatigue, Chinese herbal medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Collaborators
- Jiangzhong Pharmaceutical Co., Ltd.
- Study start
- 30 May 2023 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 13 Jan 2023 (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.
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue.
Detailed description
This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue. Our target population is adults (18-65 years old) with a COVID-19 infection history and have moderate to severe fatigue symptom at least 4 weeks after infection. The total sample size is 152. All participants will be randomly attributed to treatment group or placebo group in 1:1 ratio. The treatment duration is 4-week, and the follow-up period is also 4 weeks. Shenlingcao oral solution has been registered and marketed in mainland China, it is a safe product and pervious studies suggested it has anti-fatigue function. The primary efficacy outcome is the change of scores of Chalder fatigue scale (0-33 points) after 4-week treatment. The primary safety outcome is the number of adverse events. This study will be conducted in Hong Kong Baptist University Mr. \& Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blinded, placebo-controlled, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Shenlingcao Oral LiquidSubjects need to take the Chinese herbal medicine (Shenlingcao oral liquid) 200 ml twice per day for 4 weeks. Shenlingcao oral solution is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder. |
| Control group | Placebo comparator | Drug: Shenlingcao Oral LiquidSubjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years adults
- Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC)
- Chalder fatigue scale (0-11) not less than 4
Key exclusion criteria (6 listed)
- Have any medical history that may cause fatigue before COVID-19 infection, which include but not limited to cardiovascular diseases, chronic lung diseases, dyspnea, cognitive diseases, psychological diseases, chronic liver or renal diseases, cancer, etc.
- Must chronically taking medicines that may affect the study results.
- Severe obesity (BMI not less than 45)
- Alcoholism or drug abuse
- Allergy to Chinese medicine
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 |
|---|---|---|
| Shenlingcao Oral LiquidAlso: placebo of Shenlingcao Oral LiquidShenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder. | Drug | Control group, Treatment group |
Primary outcome
Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
Time frame: 4 weeks
The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.
8 secondary outcomes
Insomnia: Change of scores in Insomnia Severity Index (ISI)
Time frame: 4 weeks
Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)
Time frame: 4 weeks
Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
Muscle strength: Change of Hand Grip Strength (HGS)
Time frame: 4 weeks
Long Covid related symptoms
Time frame: 4 weeks
Safety: number of adverse events
Time frame: 4 weeks
Exploratory outcome: Immunology analysis
Time frame: 4 weeks
Exploratory outcome: Gut microbiota analysis
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- 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. This study is not recruiting at the moment.
Hong Kong Baptist University Chinese Medicine Clinic
Hong Kong, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shenlingcao Oral Liquid in people with Long COVID, run by Hong Kong Baptist University 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jun 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue: Change of scores in Chalder fatigue scale (0-33 points) (time frame: 4 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 28 Jun 2023.