NCT05684952

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Hong Kong Baptist University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Long COVID

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-01-15
• Completion: 2024-02-01
• First posted: 2023-01-13
• Last updated: 2023-06-28

Locations

1 site across 1 country: China