Study register · detail
Mixed
GRADE
Moderate
2 citations
Samplen = 66 Pat.
Duration7 days
ControlPlacebo
EndpointCRP level and total symptom…
Blindingdoppelblind
DesignRCT
Max. dose4500.0 mg
Routeoral
Key finding
The intervention reduced the total symptom score and moderate to severe symptoms (particularly fatigue and post-exertional malaise), but not CRP levels or quality of life.
Summary
n=66 Long COVID patients, combined plant extract (including Cannabis sativa) 4500 mg/day vs. placebo over 7 days. No significant CRP effect [MD=-0.05 mg/L, 95% CI (-0.49, 0.39)], but reduction in total symptom score [MD=-4.00, 95% CI (-7.58, -0.42)], moderate-severe fatigue [RR=0.25, 95% CI (0.08, 0.81)] and post-exertional malaise [RR=0.35, 95% CI (0.16, 0.78)]. Mild-moderate side effects.
P
PopulationAdults with Long COVID, n=66, 33 per group each
I
InterventionCombined plant extract (CPE; Citrus aurantifolia, Tiliacora triandra, Cannabis sativa, Alpinia galanga, Piper nigrum), 4500 mg/day orally, 7 days
C
ControlPlacebo
O
OutcomeNo significant difference in CRP reduction (MD −0,05 mg/L, 95% CI −0,49 to 0,39); significant reduction in total symptom score (MD −4,00, 95% CI −7,58 to −0,42), moderate to severe symptoms (RR 0,57), fatigue (RR 0,25) and PEM (RR 0,35)
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
Mixed
Citations / year
★★★★★
Authors
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Abstract
Background: Long COVID have posed a global health burden since the COVID-19 pandemic. This study aimed to evaluate the efficacy and safety of a combined plant extract (CPE) formulation, containing Citrus aurantifolia, Tiliacora triandra, Cannabis sativa, Alpinia galanga, and Piper nigrum, in participants with long COVID. A newly developed long COVID symptom questionnaire was used to evaluate outcomes.
Methods: This randomized, double-blinded, placebo-controlled trial was conducted at the College of Pharmacy, Rangsit University, Thailand. Participants were randomly assigned to receive either a CPE supplement (4500 mg/day) or a placebo for 7 days. Primary outcomes were changes in C-reactive protein (CRP) levels and the total symptom score (ranging from 0 to 57 points). Secondary outcomes included full recovery/improvement of long COVID symptoms, health-related quality of life (HRQOL), and adverse events.
Results: A total of 66 participants were enrolled, with 33 in each group. The CPE supplement did not significantly reduce CRP levels, with a median difference (MD) (95 % CI) of -0.05 (-0.49, 0.39) mg/L compared to placebo. However, the CPE group showed a reduction in the total symptom score [MD (95 % CI) of -4.00 (-7.58, -0.42)], and a reduction in overall moderate to severe symptoms [RR (95 % CI) of 0.57 (0.35, 0.91)], moderate to severe fatigue [RR (95 % CI) of 0.25 (0.08, 0.81)], and moderate to severe post-exertional malaise (PEM) [RR (95 % CI) of 0.35 (0.16, 0.78)]. Changes in HRQOL scores did not differ significantly between groups. Adverse events were mostly mild and resolved by the end of the follow-up period.
Conclusions: Our study suggests potential benefits of the CPE in alleviating moderate to severe long COVID symptoms, particularly fatigue and PEM, with an acceptable safety profile. However, larger-scale trials are necessary to validate these findings, and assessing the reliability of the long COVID symptom questionnaire is essential before its application in future studies.
Trial Registration Number: TCTR20230131004 (Registration date: 2023-01-31, Thai Clinical Trials Registry).
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