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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690609
• Other study ID #: NIS143002
• Status: Completed
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: January 19, 2018

Study information

• Verified date: February 2020
• Source: Natural Immune Systems Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 19, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

Dietary Supplement:
• CytoQuel
3 capsules daily.
• CytoQuel
2 capsules twice daily.

Locations

Country	Name	City	State
United States	NIS Labs	Klamath Falls	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Natural Immune Systems Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Fibrinogen level from baseline	Plasma fibrinogen level pg/mL	8 weeks.
Other	Change in von Willebrand Factor from baseline	von Willebrand Factor level pg/mL	8 weeks.
Primary	Change in pain level from baseline	Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.	8 weeks.
Secondary	Change in blood pressure from baseline	Systolic and diastolic blood pressure.	8 weeks.