Pain Clinical Trial
Official title:
CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
The purpose for this protocol is to perform an open-label parallel-arm clinical study in healthy subjects to evaluate the efficacy of a nutraceutical product on chronic pain, vascular health, inflammation, and overall wellness.
This is an open-label proof-of-concept human clinical study on the effects of consumption of
a nutraceutical blend. Data collection will include a core set of data pertaining to chronic
pain and inflammatory markers. Additional data collection will include blood pressure,
weight, and overall wellness.
An open-label study design will be used to evaluate the effects of consumption of the
nutraceutical product CytoQuel. The product is marketed broadly for many types of
inflammation-related health issues. The study is of 8 weeks' duration, with evaluation at
baseline, 2, and 8 weeks of product consumption. Study participants will be randomized to one
of two groups, taking either 3 caps once daily, or two caps twice daily.
At each visit, the following measurements and procedures are performed: Blood pressure and
ankle brachial index, questionnaires pertaining to pain and activities of daily living, and a
blood draw. The blood is used for testing of cytokines and vascular health related
biomarkers.
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