search
Back to results

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

Primary Purpose

Long COVID

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Shenlingcao Oral Liquid
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Long COVID focused on measuring fatigue, Chinese herbal medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Hong Kong Baptist University Chinese Medicine ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

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.

Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2023
Last Updated
June 26, 2023
Sponsor
Hong Kong Baptist University
Collaborators
Jiangzhong Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05684952
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Jiangzhong Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID
Keywords
fatigue, Chinese herbal medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A double-blinded, placebo-controlled, randomized clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Shenlingcao Oral Liquid
Other Intervention Name(s)
placebo of Shenlingcao Oral Liquid
Intervention Description
Shenlingcao oral liquid (200ml/bottle) is comprised of American Ginseng (Panacis Quinquefolii Radix), Lucid Ganoderma (Ganoderma), Rose (Rosae Rugosae Flos) and fermented Cordyceps powder.
Primary Outcome Measure Information:
Title
Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
Description
The Chalder fatigue scale (CFQ) is a questionnaire to measure the severity of tiredness in fatiguing illnesses.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Insomnia: Change of scores in Insomnia Severity Index (ISI)
Description
The Insomnia Severity Index (ISI) is a brief instrument that was designed to assess the severity of both nighttime and daytime components of insomnia.
Time Frame
4 weeks
Title
Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)
Description
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used, well-researched, self-reported measure of health.
Time Frame
4 weeks
Title
Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)
Description
HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression
Time Frame
4 weeks
Title
Muscle strength: Change of Hand Grip Strength (HGS)
Description
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
Time Frame
4 weeks
Title
Long Covid related symptoms
Description
Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.
Time Frame
4 weeks
Title
Safety: number of adverse events
Description
Assessed by number of adverse events or side effects
Time Frame
4 weeks
Title
Exploratory outcome: Immunology analysis
Description
Assessed by the change of important immune index in serumImmune index
Time Frame
4 weeks
Title
Exploratory outcome: Gut microbiota analysis
Description
Assessed by the change of gut microbiota composition and its metabolimics.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Hong Kong Baptist University Chinese Medicine Clinic
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZhaoXiang Bian, PhD
Phone
(852)3411 2905
Email
bzxiang@hkbu.edu.hk
First Name & Middle Initial & Last Name & Degree
ZhaoXiang Bian, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs