PainNCT03690609
CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
A study testing CytoQuel in people with Pain, run by Natural Immune Systems Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- CytoQuel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 19 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pain
- Being tested
- CytoQuel
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoQuelDietary supplement
3 capsules daily.
CytoQuelDietary supplement
2 capsules twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: CytoQuel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks.
Secondary outcomes (1)
Change in blood pressure from baseline
Systolic and diastolic blood pressure.
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start21 Sep 2017
- Primary completion15 Dec 2017
- Study completion19 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Jensen, Ph.D., Natural Immune Systems Inc
- Investigators
- Gitte Jensen, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690609
- Sponsor's protocol ID
- NIS143002
- Status last verified
- Feb 2020
- First submitted
- 6 Sep 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be published. At this time it is not determined whether individual data will be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CytoQuel: Clinical Documentation on Effects on Chronic Pain, Wellness, and Reduction of Inflammatory Markers
- ClinicalTrials.gov ID
- NCT03690609
- Acronym / sponsor ID
- NIS143002
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 19 Jan 2018 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical intervention, 3 capsules daily. | Active comparator | Dietary Supplement: CytoQuelParticipants 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. | Active comparator | Dietary Supplement: CytoQuelParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoQuel3 capsules daily. | Dietary supplement | Nutraceutical intervention, 3 capsules daily. |
| CytoQuel2 capsules twice daily. | Dietary supplement | Nutraceutical intervention, 2 capsules twice daily. |
Primary outcome
Change in pain level from baseline
Time frame: 8 weeks.
Pain questionnaire: Scale 0-10, with 0 being pain-free and 10 being the most pain. Change from baseline will be evaluated.
1 secondary outcome
Change in blood pressure from baseline
Time frame: 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Undecided. Data will be published. At this time it is not determined whether individual data will be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte Jensen principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoQuel in people with Pain, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level from baseline (time frame: 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.