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

NCT03690609 | Completed

• 1 other identifier: NIS143002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in blood pressure from baseline

  8 weeks.

Other Outcomes (2)

• Change in Fibrinogen level from baseline

  8 weeks.

• Change in von Willebrand Factor from baseline

  8 weeks.

Study Arms (2)

Nutraceutical intervention, 3 capsules daily.

ACTIVE COMPARATOR

Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 3 capsules daily in the morning.

Dietary Supplement: CytoQuel

Nutraceutical intervention, 2 capsules twice daily.

ACTIVE COMPARATOR

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.

Dietary Supplement: CytoQuel

Interventions

CytoQuel DIETARY_SUPPLEMENT

3 capsules daily.

Nutraceutical intervention, 3 capsules daily.

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Natural Immune Systems Inc: lead

Study Sites (1)

NIS Labs

Klamath Falls, Oregon, 97601, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gitte Jensen

  NIS Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: October 1, 2018
• Study Start: September 21, 2017
• Primary Completion: December 15, 2017
• Study Completion: January 19, 2018
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

US (1)