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

Phase 2

Recruiting

• Conditions: Long COVID
• Interventions: Drug: Shenlingcao Oral Liquid

• Registration Number: NCT05684952
• Lead Sponsor: Hong Kong Baptist University

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.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-13
• Study Start: 2023-05-30
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-26
• Last Update Posted: 2023-06-28
• Primary Completion: 2024-01-15
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Shenlingcao Oral Liquid	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.
Control group	Shenlingcao Oral Liquid	Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Fatigue: Change of scores in Chalder fatigue scale (0-33 points)	4 weeks	The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.

Secondary Outcome Measures

Name	Time	Method
Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)	4 weeks	HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression
Insomnia: Change of scores in Insomnia Severity Index (ISI)	4 weeks	The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)	4 weeks	The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health.
Long Covid related symptoms	4 weeks	Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.
Exploratory outcome: Gut microbiota analysis	4 weeks	Assessed by the change of gut microbiota composition and its metabolimics.
Exploratory outcome: Immunology analysis	4 weeks	Assessed by the change of important immune index in serumImmune index
Muscle strength: Change of Hand Grip Strength (HGS)	4 weeks	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
Safety: number of adverse events	4 weeks	Assessed by number of adverse events or side effects

Trial Locations

Locations (1)

Hong Kong Baptist University Chinese Medicine Clinic; 🇨🇳 Hong Kong, China