CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
- Conditions
- Pain
- Interventions
- Dietary Supplement: CytoQuel
- Registration Number
- NCT03690609
- Lead Sponsor
- Natural Immune Systems Inc
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutraceutical intervention, 3 capsules daily. CytoQuel Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 3 capsules daily in the morning. Nutraceutical intervention, 2 capsules twice daily. CytoQuel Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 4 capsules daily: Two in the morning and two later in the day.
- Primary Outcome Measures
Name Time Method Change in pain level from baseline 8 weeks. Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
- Secondary Outcome Measures
Name Time Method Change in blood pressure from baseline 8 weeks. Systolic and diastolic blood pressure.
Trial Locations
- Locations (1)
NIS Labs
🇺🇸Klamath Falls, Oregon, United States