32
Participants
Start Date
January 1, 2025
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Artemisia Annua Leaf
"The intervention is Artecinua™ which is an organic Artemisia annua dried leaf powder in a vegan / kosher/ halal capsule. Artemisia annua L is classified as a 'generally regarded as safe' (GRAS) herb. Participants will be instructed to wean up to a full 5g dose by the following schedule.~1. gram (3 caps) 1st day,~2. grams (6 caps) 3/am, 3/pm, for the 3rd day,~3. grams (9 caps) 3/am 3/noon 3/pm for the 5th day,~4. grams (12 caps) 4/am, 4/noon, 4/pm for the 7th day,~5. grams (15 caps) 5/am, 5/noon, 5/pm for rest of intervention period (4 weeks)~Containers of ArtecinuaTM will be kept in a secured cabinet before being administered, under climate-controlled conditions, and checked weekly to ensure consistent ambient temperature.~The justification of the 5g a day dosing is based on empiric experience and is in line with recommended dosages by the pharmacopeia of the People's Republic of China and has been previously used in clinical trials"
placebo
We have chosen dried-leaf alfalfa of equal weight and dosing to the interventional product (5 grams, 15 caps, 5/am, 5/noon, 5/pm for the 4 weeks of the intervention period plus an additional 1 week dose escalation period to match the dosing of the Artemisia product). We have chosen this as a comparator in consultation with SIBO and herbal medicine content experts as alfalfa matches the texture and color of Artemisia annua and, in the doses used, will provide no meaningful amounts of FODMAPs or antimicrobial phytochemicals. The alfalfa will be sourced from Bulk Apotherapy, LCC, and encapsulated at the same facility as the Artemisia capsules. Containers of placebo capsules will be kept in a secured cabinet before being administered, under climate-controlled conditions, and checked weekly to ensure consistent ambient temperature.
RECRUITING
Helfgott Research Institute - National University of Natural Medicine, Portland
atelier temenos
UNKNOWN
National University of Natural Medicine
OTHER