CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers

Completed · Not applicable

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT03690609

Run by

Natural Immune Systems Inc

People needed

21

Starts

2017-09-21

Expected to finish

2018-01-19

Last updated by the study team

2020-02-12

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult people of either gender;
• Age 30-75 years (inclusive);
• BMI between 20.0 and 34.9 (inclusive);
• Experiencing chronic pain in at least one specific anatomical area for more than 6 months.

You may not qualify if…

• Active uncontrolled auto-immune disease (for example: rheumatoid arthritis, lupus, inflammatory bowel disease, Celiac disease);
• Known active cardiovascular health issues;
• Cancer during past 12 months;
• Chemotherapy during past 12 months;
• Currently taking blood pressure medication;
• Currently taking blood thinning medication (81mg aspirin allowed);
• Currently taking cholesterol-lowering medication (for example: statins);
• Currently taking Coumadin;
• Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product;
• Currently taking prescription pain medications;
• Getting regular joint injections (such as cortisone shots);
• Major surgery within the past 3 months;
• Major trauma within the past 3 months;
• Any other condition or observation that the investigator judges may adversely affect the person's ability to complete the study;
• Any other significant disease or disorder that the investigator judges may put the subject at risk because of participation in the study, or may influence the result of the study;
• Hypersensitivity or known allergy to green tea or black tea;
• Participation in another research study involving an investigational product in the past month;
• Planned surgery within 2 weeks of completing the study;
• Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal];
• Unwilling to maintain a constant intake of supplements over the duration of the study;
• Women who are pregnant, nursing, or trying to become pregnant.

Where it is running

• NIS Labs — Klamath Falls, Oregon, United States

Full record on ClinicalTrials.gov

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