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

Last updated: June 26, 2023
Sponsor: Hong Kong Baptist University
Overall Status: Active - Recruiting

Phase

2

Condition

Pain (Pediatric)

Treatment

Shenlingcao Oral Liquid

Clinical Study ID

NCT05684952
LongCov-fatigue CHM
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Have any medical history that may cause fatigue before COVID-19 infection, whichinclude 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

Total Participants: 152
Treatment Group(s): 1
Primary Treatment: Shenlingcao Oral Liquid
Phase: 2
Study Start date:
May 30, 2023
Estimated Completion Date:
February 01, 2024

Study 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.

Connect with a study center

  • Hong Kong Baptist University Chinese Medicine Clinic

    Hong Kong,
    China

    Active - Recruiting

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