An observational study in Aconite Poisoning, sponsored by The University of Hong Kong. Recruiting at 2 sites in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by The University of Hong Kong · Observational
Aconitine and related alkaloids are potent cardiotoxins and neurotoxins found in the Aconitum species used in traditional Chinese medicine (TCM), such as 'Chuanwu', 'Caowu' and 'Fuzi'. They pose significant health risks when used inappropriately without professional supervision. Patients with acute aconite poisoning often present with a combination of cardiovascular, neurological, and gastrointestinal toxicities, which can occur after an overdose, inadequate processing of the aconite roots, erroneous use of tincture preparations, and contamination or substitution of other herbs with aconite roots. Timely diagnosis of aconite poisoning remains challenging due to the long laboratory turnaround time. The aim of this study is to develop an aptamer-based lateral flow device (LFD) for point-of-care detection of aconitine and its metabolites (benzoylaconine and aconine) and evaluate its diagnostic performance.
In this study, the investigators will first develop an aptamer-based LFD for point-of-care detection of aconitine, benzoylaconine and aconine in human urine samples. The investigators will perform in vitro selection of binding aptamers for each of the target alkaloids (aconitine, benzoylaconine and aconine) using systematic evolution of ligands by exponential enrichment (SELEX). High throughput sequencing (HTS) and bioinformatics analysis will be performed to characterise the selected aptamers. The selected aptamers will be integrated into ELISA and LFD competition assay. Spiked samples (80 samples, including 20 for each target alkaloids and 20 controls) will be used for calibrating the LFD reader and determining the cutoff points.
The investigators will then conduct a cross-sectional study on stored human urine samples to evaluate the diagnostic performance of the newly developed LFD. The gold standard will be the independent laboratory analysis by the Centre for PanorOmic Sciences (CPOS) at The University of Hong Kong.
Patient urine samples will be stored at 4°C in emergency departments or Chinese medicine clinics. The samples will then be transported to the Laboratory Block of the School of Biomedical Sciences by our research staff within 12 hours of collection. LFD assays will be performed in batch with 5 replicates. 150 µL aliquots of patients' urine sample will be thawed on ice and added to the LFD sample pad. After the flow has completed (approximately 5 minutes), a LFD reader will be used to scan the line intensities for statistical analysis and diagnosis. The operators of the LFD assays will be blinded to the CPOS analytic results.
The primary outcome is the accuracy of the newly developed LFD in detecting aconitine, benzoylaconine and aconine in human urine samples. The secondary outcomes include other diagnostic metrics, such as sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios, the area under the receiver operating characteristic curve and their respective 95% confidence intervals (CIs). The hypothsis is that the LFD can achieve a high diagnostic accuracy, with a sum of the lower bounds of sensitivity and specificity 95% CIs exceeding 1.75.
The study will be conducted in full compliance with the Declaration of Helsinki. The risks of participating in this study will be minimal since the recruited participants only need to submit urine samples. This study will also adhere to the safety guidelines of the University of Hong Kong Biological Safety Policy.
98 studies on the registry are indexed under Poisoning; 16 are open to participants now.
This study's planned enrollment of 90 is below the median of 122 across 41 observational studies indexed under Poisoning.
Browse Poisoning studies →The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The patient participants are recruited from 3 sources. The Aconite Poisoned Group will include adult patients who present to the emergency departments of Queen Mary Hospital or United Christian Hospital and are reported to the Hong Kong Poison Control Centre for acute aconite poisoning.
The Aconite Therapeutic Group will include adult patients who have therapeutic use of aconite in Chinese Medicine Clinics.
The Control Group will include adult emergency department patients who have no exposure to aconitine, benzoylaconine, or aconine within 30 days and no clinical evidence of aconite toxicities
Inclusion Criteria (Aconite Poisoned Group):
Exclusion Criteria (Aconite Poisoned Group):
Inclusion Criteria (Aconite Therapeutic Use Group):
Exclusion Criteria (Aconite Therapeutic Use Group):
- Refusal of informed consent for urine collection.
Inclusion Criteria (Control Group):
Exclusion Criteria (Control Group):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute aconite poisoning reported to the Hong Kong Poison Control Centre
Patients with therapeutic use of aconite with no clinical toxicities in Chinese medicine clinics
Patients with no exposure to aconite
The accuracy of the newly developed lateral flow device in detecting aconitine, benzoylaconine and aconine in human urine samples
The sum of the lower bounds of the 95% confidence intervals of sensitivity and specificity
Time frame: 0 hour
True positive
The number of correctly identified cases with aconite exposure
Time frame: 0 hour
False positive
The number of incorrectly identified cases with no aconite exposure
Time frame: 0 hour
True Negative
The number of correctly identified cases with no aconite exposure
Time frame: 0 hour
False Negative
Number of missed cases with aconite exposure
Time frame: 0 hour
Sensitivity
True positive/(True positive + False negative) and its 95% confidence interval
Time frame: 0 hour
Specificity
True negative/(False positive + True negative) and its 95% confidence interval
Time frame: 0 hour
Positive likelihood ratio
(Sensitivity/ (1 - Specificity)) and its 95% confidence interval
Time frame: 0 hour
Negative likelihood ratio
(1 - Sensitivity)/Specificity) and its 95% confidence interval
Time frame: 0 hour
Positive predictive values
(True positive/(True positive + False positive)) and its 95% confidence interval
Time frame: 0 hour
Negative predictive value
(True negative/(False negative + True negative)) and its 95% confidence interval
Time frame: 0 hour
The area under the receiver operating characteristic curve
The area under the receiver operating characteristic curve and its 95% confidence interval
Time frame: 0 hour
Plan to share: Undecided — Additional IRB approval for IPD is required due to local regulations on data privacy
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Dec 2026, 14 months after the start.
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