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

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CytoQuel
CytoQuel
Sponsored by
Natural Immune Systems Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NIS Labs

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nutraceutical intervention, 3 capsules daily.

Nutraceutical intervention, 2 capsules twice daily.

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in blood pressure from baseline
Systolic and diastolic blood pressure.

Full Information

First Posted
September 6, 2018
Last Updated
February 10, 2020
Sponsor
Natural Immune Systems Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03690609
Brief Title
CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
Official Title
CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
January 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Natural Immune Systems Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutraceutical intervention, 3 capsules daily.
Arm Type
Active Comparator
Arm Description
Participants will consume the nutraceutical blend CytoQuel at a dose of 1850 mg, by consuming 3 capsules daily in the morning.
Arm Title
Nutraceutical intervention, 2 capsules twice daily.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
CytoQuel
Intervention Description
3 capsules daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
CytoQuel
Intervention Description
2 capsules twice daily.
Primary Outcome Measure Information:
Title
Change in pain level from baseline
Description
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
Time Frame
8 weeks.
Secondary Outcome Measure Information:
Title
Change in blood pressure from baseline
Description
Systolic and diastolic blood pressure.
Time Frame
8 weeks.
Other Pre-specified Outcome Measures:
Title
Change in Fibrinogen level from baseline
Description
Plasma fibrinogen level pg/mL
Time Frame
8 weeks.
Title
Change in von Willebrand Factor from baseline
Description
von Willebrand Factor level pg/mL
Time Frame
8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitte Jensen
Organizational Affiliation
NIS Labs
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIS Labs
City
Klamath Falls
State/Province
Oregon
ZIP/Postal Code
97601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be published. At this time it is not determined whether individual data will be made available to other researchers.

Learn more about this trial

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

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