The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue

Long COVID Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05684952
• Other study ID #: LongCov-fatigue CHM
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: June 2023
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: February 1, 2024
• Est. primary completion date: January 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Long COVID

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Hong Kong Baptist University Chinese Medicine Clinic	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Hong Kong Baptist University	Jiangzhong Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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.	4 weeks
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	Long Covid related symptoms	Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.	4 weeks
Secondary	Safety: number of adverse events	Assessed by number of adverse events or side effects	4 weeks
Secondary	Exploratory outcome: Immunology analysis	Assessed by the change of important immune index in serumImmune index	4 weeks
Secondary	Exploratory outcome: Gut microbiota analysis	Assessed by the change of gut microbiota composition and its metabolimics.	4 weeks