Aconite PoisoningALPTH1NCT07456592
Development of an Aptamer-based Lateral Flow Device for Point-of-care Detection of Toxic Chinese Medicine Herbs (ALPTH Project)
An observational study of Aconite Poisoning, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aconite Poisoning
- How many people
- 90 participants
- Where
- 2 sitesHong Kong
- Study dates
- 15 Oct 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- adult patients aged 18 years or above
- clinical presentations consistent with acute aconite poisoning, including neurological, gastrointestinal, or cardiovascular symptoms
- exposure to aconite alkaloids within 3 days
- adult patients aged 18 years or above
- documented history of using aconite for therapeutic purposes, as prescribed by a qualified practitioner in a Chinese medicine clinic
- exposure to aconite alkaloids within 3 days
Show all 9Show fewer
- adults aged 18 years or above
- no documented history of exposure to aconitine, benzoylaconine, or aconine within 30 days
- no clinical evidence of aconite toxicities
Who cannot join
- refusal of informed consent for urine collection
- alternative explanations for clinical presentations
- Refusal of informed consent for urine collection.
- refusal of informed consent for urine collection
- recent history of poisoning or overdose from any other substances within 30 days
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
Accident and Emergency Department, Queen Mary Hospital
Hong Kong
Rex Pui Kin Lam, MBBS, MPH, FHKCEM, +852 39179413, lampkrex@hku.hk
- Recruiting
Accident and Emergency Department, United Christian Hospital
Hong Kong
Rex Pui Kin Lam, MBBS, MPH, FHKCEM, +852 39179413, lampkrex@hku.hk
About this study
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.
Read the detailed description
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.
- Conditions
- Aconite Poisoning
- Keywords
- aconite, traditional Chinese medicine, poisoning, aptamer, point-of-care test
- Medical subject headings
- Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aconite Poisoned Group | Patients with acute aconite poisoning reported to the Hong Kong Poison Control Centre | |
| Aconite Therapeutic Use Group | Patients with therapeutic use of aconite with no clinical toxicities in Chinese medicine clinics | |
| Control Group | Patients with no exposure to aconite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 hour
Secondary outcomes (11)
True positive
The number of correctly identified cases with aconite exposure
Measured: 0 hour
False positive
The number of incorrectly identified cases with no aconite exposure
Measured: 0 hour
True Negative
The number of correctly identified cases with no aconite exposure
Measured: 0 hour
False Negative
Number of missed cases with aconite exposure
Measured: 0 hour
Sensitivity
True positive/(True positive + False negative) and its 95% confidence interval
Measured: 0 hour
Specificity
True negative/(False positive + True negative) and its 95% confidence interval
Measured: 0 hour
Positive likelihood ratio
(Sensitivity/ (1 - Specificity)) and its 95% confidence interval
Measured: 0 hour
Negative likelihood ratio
(1 - Sensitivity)/Specificity) and its 95% confidence interval
Measured: 0 hour
Positive predictive values
(True positive/(True positive + False positive)) and its 95% confidence interval
Measured: 0 hour
Negative predictive value
(True negative/(False negative + True negative)) and its 95% confidence interval
Measured: 0 hour
The area under the receiver operating characteristic curve
The area under the receiver operating characteristic curve and its 95% confidence interval
Measured: 0 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aconite PoisoningStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- School of Biomedical Sciences, The University of Hong Kong, Hong Kong Poison Control Centre, Hospital Authority
- Responsible party
- Principal investigator, Lam Pui Kin, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456592
- Sponsor's protocol ID
- ALPTH1
- Acronym
- ALPTH1
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Additional IRB approval for IPD is required due to local regulations on data privacy
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Aptamer-based Lateral Flow Device for Point-of-care Detection of Toxic Chinese Medicine Herbs (ALPTH Project)
- ClinicalTrials.gov ID
- NCT07456592
- Acronym / sponsor ID
- ALPTH1 / ALPTH1
- Conditions
- Aconite Poisoning
- Keywords
- aconite, traditional Chinese medicine, poisoning, aptamer, point-of-care test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- School of Biomedical Sciences, The University of Hong Kong, Hong Kong Poison Control Centre, Hospital Authority
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aconite Poisoned Group | – | –Patients with acute aconite poisoning reported to the Hong Kong Poison Control Centre |
| Aconite Therapeutic Use Group | – | –Patients with therapeutic use of aconite with no clinical toxicities in Chinese medicine clinics |
| Control Group | – | –Patients with no exposure to aconite |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (9 listed)
- adult patients aged 18 years or above
- clinical presentations consistent with acute aconite poisoning, including neurological, gastrointestinal, or cardiovascular symptoms
- exposure to aconite alkaloids within 3 days
- adult patients aged 18 years or above
- documented history of using aconite for therapeutic purposes, as prescribed by a qualified practitioner in a Chinese medicine clinic
Key exclusion criteria (5 listed)
- refusal of informed consent for urine collection
- alternative explanations for clinical presentations
- Refusal of informed consent for urine collection.
- refusal of informed consent for urine collection
- recent history of poisoning or overdose from any other substances within 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of the newly developed lateral flow device in detecting aconitine, benzoylaconine and aconine in human urine samples
Time frame: 0 hour
The sum of the lower bounds of the 95% confidence intervals of sensitivity and specificity
11 secondary outcomes
True positive
Time frame: 0 hour
False positive
Time frame: 0 hour
True Negative
Time frame: 0 hour
False Negative
Time frame: 0 hour
Sensitivity
Time frame: 0 hour
Specificity
Time frame: 0 hour
Positive likelihood ratio
Time frame: 0 hour
Negative likelihood ratio
Time frame: 0 hour
Positive predictive values
Time frame: 0 hour
Negative predictive value
Time frame: 0 hour
The area under the receiver operating characteristic curve
Time frame: 0 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided. Additional IRB approval for IPD is required due to local regulations on data privacy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aconite Poisoning, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rex Pui Kin Lam, MBBS, MPH, FHKCEM (+85239179413, lampkrex@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of the newly developed lateral flow device in detecting aconitine, benzoylaconine and aconine in human urine samples (time frame: 0 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.