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

Hong Kong Baptist University

Status and phase: Enrolling; Phase 2

Conditions: Long COVID

Treatments: Drug: Shenlingcao Oral Liquid

Study type: Interventional

Funder types: Other

Identifiers

NCT05684952

LongCov-fatigue CHM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

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.

Treatment:

Drug: Shenlingcao Oral Liquid

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: Shenlingcao Oral Liquid