84 Selection of Commercial Echinacea Liquid Extracts for a Clinical Trial in Children: A Pilot Study Conducted on 10 Products Among the most Popular Brands in Canada
Bibliographic record
Abstract
Echinacea products (including E. purpurea and E. angustifolia) are popular in Canada, with more than 1.9 million units sold last year. They are purported to stimulate the immune system, and have been studied for the treatment of upper respiratory tract infections (URTI) in adults. We have designed a clinical study to test the efficacy of these products in URTI in healthy children. A major hurdle, while dealing with natural health products is the lack of standardization that may yield to heterogeneity in the amount of the different components from one sample to another, preventing the evaluation of their true effects in a clinical trial setting. Our goal was to identify products that would be suitable for the clinical trial, i.e. those with the least heterogeneity that demonstrated evidence of biologic activity in vivo. We selected 5 Echinacea Angustifolia products and 5 Echinacea Purpurea products using following criteria : 1) liquid extract; 2) not blended; 3) alcohol content <20%; and 4) among the most popular commercially available brands in Canada. Random samplings within and between lots of selected brands were submitted for blind qualitative and quantitative analysis using HPLC and mass spectrometry. They were also tested for their biological activity in vitro – in a lymphocytes proliferation assay and a macrophages activation assay, and in vivo – using Listeria infection challenge. This study, the first of its kind for Echinacea products in Canada, is an effort to obtain independent information on product quality, as a preliminary and important step of the design of a clinical trial to ensure the same amount of active ingredient in each dose given to the subjects. We provide an overview of challenges and solutions when evaluating a natural health product for a clinical trial. These challenges reflect not only product heterogeneity, but also the current regulatory environment for natural health product manufacturing standards.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.009 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".