Aptamer-based rapid urine test for toxic aconite herbs
Official title: Development of an Aptamer-based Lateral Flow Device for Point-of-care Detection of Toxic Chinese Medicine Herbs (ALPTH Project)
Run by The University of Hong Kong · NCT07456592 · Data updated 2026-11-12
This project will try a rapid urine test to detect toxic aconite alkaloids in adults who may have been exposed or who use aconite therapeutically.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07456592 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) presenting within three days of suspected aconite exposure or those with documented therapeutic aconite use who can provide a urine sample.
✕Probably not a fit
Patients with exposures outside the expected urine detection window, without available urine samples, or with poisoning from other agents are unlikely to benefit from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Investigators will generate aptamers that bind aconitine, benzoylaconine, and aconine using SELEX and characterize them by high-throughput sequencing and bioinformatics. Selected aptamers will be integrated into ELISA formats and a lateral flow device (LFD), and the LFD reader will be calibrated using 80 spiked urine samples and controls. The diagnostic performance of the LFD will be tested in a cross-sectional analysis of stored patient urine samples, with independent laboratory analysis at the Centre for PanorOmic Sciences (CPOS) as the reference standard. Urine samples will be collected at participating emergency departments and Chinese medicine clinics, transported to the HKU laboratory within 12 hours, and LFD assays performed in batches with five replicates.
Why it matters
Potential benefit: If successful, the test could provide a rapid bedside result to speed diagnosis and treatment of aconite poisoning.
How similar studies have gone: Aptamer-based lateral flow assays have shown laboratory promise for detecting small-molecule toxins, but clinical application for aconite alkaloids is novel and not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria (Aconite Poisoned Group): * 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 Exclusion Criteria (Aconite Poisoned Group): * refusal of informed consent for urine collection * alternative explanations for clinical presentations Inclusion Criteria (Aconite Therapeutic Use Group): * 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 Exclusion Criteria (Aconite Therapeutic Use Group): \- Refusal of informed consent for urine collection. Inclusion Criteria (Control Group): * 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 Exclusion Criteria (Control Group): * refusal of informed consent for urine collection * recent history of poisoning or overdose from any other substances within 30 days
Where it's running
-
Accident and Emergency Department, Queen Mary Hospital
Hong Kong, Hong Kong Recruiting -
Accident and Emergency Department, United Christian Hospital
Hong Kong, Hong Kong Recruiting
Study contacts
- Study coordinator: Rex Pui Kin Lam, MBBS, MPH, FHKCEM
- Email: lampkrex@hku.hk
- Phone: +85239179413
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.