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

June 26, 2023 updated by: ZhaoXiang Bian, Hong Kong Baptist University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Hong Kong Baptist University Chinese Medicine Clinic
        • Contact:
        • Principal Investigator:
          • ZhaoXiang Bian, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
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.
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.
Other Names:
  • placebo of Shenlingcao Oral Liquid
Placebo Comparator: Control group
Subjects need to take the placebo of Shenlingcao oral liquid 200 ml twice per day for 4 weeks.
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.
Other Names:
  • placebo of Shenlingcao Oral Liquid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia: Change of scores in Insomnia Severity Index (ISI)
Time Frame: 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.
4 weeks
Quality of life: Change of scores in 36-Item Short Form Survey (SF-36)
Time Frame: 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.
4 weeks
Mood: Change of scores in The Hospital Anxiety and Depression Scale (HADS)
Time Frame: 4 weeks
HADS was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression
4 weeks
Muscle strength: Change of Hand Grip Strength (HGS)
Time Frame: 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
4 weeks
Long Covid related symptoms
Time Frame: 4 weeks
Assessed by the self-reporting severity of 27 common symptoms after COVID-19 infection.
4 weeks
Safety: number of adverse events
Time Frame: 4 weeks
Assessed by number of adverse events or side effects
4 weeks
Exploratory outcome: Immunology analysis
Time Frame: 4 weeks
Assessed by the change of important immune index in serumImmune index
4 weeks
Exploratory outcome: Gut microbiota analysis
Time Frame: 4 weeks
Assessed by the change of gut microbiota composition and its metabolimics.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Baptist University

Collaborators

Jiangzhong Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

January 15, 2024

Study Completion (Estimated)

February 1, 2024

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LongCov-fatigue CHM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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