Acute kratom exposure
Conditions
Interventions
Participants receive kratom tea prepared with 3 grams of kratom tea powder during the first treatment period and placebo tea prepared from Chinese cabbage (Brassica rapa subsp. pekinensis) powder duri
Experimental Drug,Experimental Drug
Kratom-Placebo Sequence ,Placebo-Kratom Sequence
Sponsors
Faculty of Optometry, Siam University
Eligibility
Sex/Gender
Male
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male participants aged 20 to 40 years old 2. Body weight between 50 and 75 kilograms 3. Regular kratom intake 1-3 days per week, 1-2 times per day, with each dose not exceeding 5 g, for a duration of 3 months to less than 3 years.
Exclusion criteria
Exclusion criteria: 1. History of intraocular surgery or eye trauma. 2. History of ocular diseases such as glaucoma, diabetic retinopathy, cataract, keratoconus, or eyelid disorders. 3. History of neurological disorders or use of medications affecting the central nervous system. 4. Known allergy or adverse reaction to kratom consumption. 5. Current use of systemic or topical corticosteroids (oral or ophthalmic). 6. Abnormally high or low blood pressure beyond safe limits. 7. Use of medications metabolized by cytochrome P450 enzymes, including anticoagulants, psychotropic drugs, and opioid analgesics. 8. Presence of insomnia or chronic sleep disorders. 9. History of liver, kidney, or thyroid dysfunction. 10. History of chronic medical condition such as cardiovascular disease, diabetes, cancer, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure Baseline, 30 minutes, 60 minutes, and 90 minutes after intervention Non contact tonometer | — |
Secondary
| Measure | Time frame |
|---|---|
| Anterior chamber angle Anterior chamber depth Anterior chamber volume Baseline, 30 minutes, 60 minutes, and 90 minutes after intervention Oculus Pentacam ,Central corneal thickness Baseline, 30 minutes, 60 minutes, and 90 minutes after intervention WAM 800 open view autorefractor,Pupil size Baseline, 30 minutes, 60 minutes, and 90 minutes after intervention WAM 800 open view autorefractor,Choroidal thickness Baseline, 30 minutes, 60 minutes, and 90 minutes after intervention Optical coherence tomography,Blood pressure and heart rate Baseline, 30 minutes, 60 minutes, and 90 minutes after intervention Automatic blood pressure monitor | — |
Countries
Thailand
Contacts
Public ContactTrinnawat Tongchit
Faculty of Optometry, Siam University
Outcome results
None listed