Evaluating a Chinese herbal medicine for fatigue in long COVID patients
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 study is testing a Chinese herbal medicine to see if it can help adults with long COVID who are feeling very tired.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hong Kong Baptist University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05684952 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blinded, placebo-controlled study aimed at assessing the efficacy and safety of Shenlingcao oral liquid in treating fatigue associated with long COVID. The trial will involve adults aged 18-65 who have experienced moderate to severe fatigue for at least four weeks following a COVID-19 infection. Participants will be randomly assigned to receive either the herbal treatment or a placebo for four weeks, followed by a four-week follow-up period. The primary outcomes will measure changes in fatigue levels using the Chalder fatigue scale and monitor any adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a history of COVID-19 and moderate to severe fatigue lasting at least four weeks.
Not a fit: Patients with pre-existing conditions that cause fatigue or those with severe obesity, substance abuse issues, or allergies to Chinese medicine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate fatigue symptoms in long COVID patients, improving their quality of life.
How similar studies have performed: Previous studies have suggested that Shenlingcao has anti-fatigue properties, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- Hong Kong Baptist University Chinese Medicine Clinic — Hong Kong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.