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Clinical trial

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

ID
Name
LongCov-fatigue CHM
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.
Trial arms
Trial start
2023-05-30
Estimated PCD
2024-01-15
Trial end
2024-02-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Control group, Treatment group
Other names:
placebo of Shenlingcao Oral Liquid
Size
152
Primary endpoint
Fatigue: Change of scores in Chalder fatigue scale (0-33 points)
4 weeks
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A double-blinded, placebo-controlled, randomized clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 152, 'type': 'ESTIMATED'}}
Updated at
2023-06-28

1 organization

1 product

1 indication

Organization
Hong Kong Baptist University
Product
Shenlingcao
Indication
Long COVID