Aptamer-based rapid urine test for toxic aconite herbs
Development of an Aptamer-based Lateral Flow Device for Point-of-care Detection of Toxic Chinese Medicine Herbs (ALPTH Project)
The University of Hong Kong · NCT07456592
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 |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong (other) |
| Locations | 2 sites (Hong Kong and 1 other locations) |
| Trial ID | NCT07456592 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hong Kong and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aconite Poisoning, aconite, traditional Chinese medicine, poisoning, aptamer, point-of-care test