Clinical trial NCT05684952: The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Long COVID
Keywords: fatigue
Chinese herbal medicine
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Jiangzhong Pharmaceutical Co., Ltd.
First posted: 2023-01-13
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blinded, placebo-controlled, randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 18-65 years adults
2. Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC)
3. Chalder fatigue scale (0-11) not less than 4

Exclusion Criteria:

1. 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.
2. Must chronically taking medicines that may affect the study results.
3. Severe obesity (BMI not less than 45)
4. Alcoholism or drug abuse
5. Allergy to Chinese medicine
6. Pregnancy, or plan to be pregnant, or lactating women

Primary outcomes:
measure: Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
timeFrame: 4 weeks
Secondary outcomes:
measure: Insomnia: Change of scores in Insomnia Severity Index (ISI)
timeFrame: 4 weeks
measure: Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)
timeFrame: 4 weeks
measure: Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 weeks
measure: Muscle strength: Change of Hand Grip Strength (HGS)
timeFrame: 4 weeks
measure: Long Covid related symptoms
timeFrame: 4 weeks
measure: Safety: number of adverse events
timeFrame: 4 weeks
measure: Exploratory outcome: Immunology analysis
timeFrame: 4 weeks
measure: Exploratory outcome: Gut microbiota analysis
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Baptist University Chinese Medicine Clinic
Study officials:
References: