Back to resultsEffect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain
Primary Purpose
Knee Pain Intermittent
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
JOINTRUS®
80% dose of JOINTRUS®
62.4% dose of JOINTRUS®
Starch 100%
Sponsored by
About this trial
This is an interventional treatment trial for Knee Pain Intermittent
Eligibility Criteria
Inclusion Criteria:
- sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4.
Exclusion Criteria:
- current medication use related to arthritis;
- current use of FAC containing products;
- clinical or radiological diagnosis as moderate degree arthritis accompanied by peri-articular spur formation, irregular joint margin, and/or subchondral cyst;
- previous history of knee surgery;
- pregnant, breastfeeding, or practicing contraception with reliable methods, or not accepting our guidelines during the research periods;
- major pain other than knee joint pain;
- current treatment of gastritis or gastric ulcer;
- abnormal screening laboratory results;
- major cardiac, renal disease, or disability that could affect adverse effect assessment or interfere with study completion when enrolled;
- history of major procedures or operations that might affect study results;
- enrollment in another clinical trial or human application testing; and
- judged as unsuitable for human application testing.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
100% of JOINTRUS®
80% of JOINTRUS®
62.4% of JOINTRUS®
Starch 100%
Arm Description
After randomization, 100% dose of JOINTRUS® is taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
After randomization, 80% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
After randomization, 62.4% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
After randomization, starch 100% was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
Outcomes
Primary Outcome Measures
CHANGE of Pain
using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible)
Secondary Outcome Measures
difference in NRS pain score from baseline within groups
change of the WOMAC score
using the Korean version of WOMAC
Global Impression of Change
a scale ranging from 1 (very much improved) to 7 (very much worse).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02800759
Brief Title
Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain
Official Title
The Minimal Effective Dose of Cis-9-cetylmyristoleate (CMO) in Persons Presenting With Knee Joint Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cis-9-cetylmyristoleate (CMO) is a naturally occurring fatty acid complex (FAC). Nutraceuticals containing CMO are used to improve knee pain despite the lack of placebo-controlled studies in humans. The aim of the double-blind controlled clinical trial is to explore the minimal effective dose of CMO for relieving knee joint pain.
Detailed Description
Methods: Twenty-eight subjects, who are clinically or radiologically diagnosed as having mild degree arthritic knee joint pain, are randomized into 3 groups; Groups A, B, C that contained 100%, 80%, and 62.4% of fatty acid component with 12.5% of Cis-9-cetylmyristoleate (CMO), and control Group D (starch 100%). The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Intermittent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100% of JOINTRUS®
Arm Type
Active Comparator
Arm Description
After randomization, 100% dose of JOINTRUS® is taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
Arm Title
80% of JOINTRUS®
Arm Type
Active Comparator
Arm Description
After randomization, 80% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
Arm Title
62.4% of JOINTRUS®
Arm Type
Active Comparator
Arm Description
After randomization, 62.4% dose of JOINTRUS® was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
Arm Title
Starch 100%
Arm Type
Placebo Comparator
Arm Description
After randomization, starch 100% was taken per day for 3 months in 7 sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4. This study included a 7-day baseline screening period (Visit 1) and was followed by randomization (Visit 2), a 12-week ingestion period with clinic visits at week 4 (Visit 3), 8 (Visit 4), and 12 (Visit 5) after starting ingestion, and a 4-week post-ingestion safety follow-up. The pain intensity, functional disability state and change in the general status were assessed for a 12-week ingestion period.
Intervention Type
Dietary Supplement
Intervention Name(s)
JOINTRUS®
Other Intervention Name(s)
100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Intervention Description
100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Intervention Type
Dietary Supplement
Intervention Name(s)
80% dose of JOINTRUS®
Other Intervention Name(s)
80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Intervention Description
80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Intervention Type
Dietary Supplement
Intervention Name(s)
62.4% dose of JOINTRUS®
Intervention Description
62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Intervention Type
Dietary Supplement
Intervention Name(s)
Starch 100%
Intervention Description
0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
Primary Outcome Measure Information:
Title
CHANGE of Pain
Description
using the NRS score, composed of an 11-point scale from 0 (no pain) to 10 (the worst pain possible)
Time Frame
change from baseline at 3 months
Secondary Outcome Measure Information:
Title
difference in NRS pain score from baseline within groups
Time Frame
at 1-month follow-up, at 2-month follow-up, and at 3-month follow-up
Title
change of the WOMAC score
Description
using the Korean version of WOMAC
Time Frame
change from baseline at 3 months
Title
Global Impression of Change
Description
a scale ranging from 1 (very much improved) to 7 (very much worse).
Time Frame
at 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
sub-healthy persons >18 years of age and knee joint pain with a 0-10 numerical rating scale (NRS) pain score ≤ 4.
Exclusion Criteria:
current medication use related to arthritis;
current use of FAC containing products;
clinical or radiological diagnosis as moderate degree arthritis accompanied by peri-articular spur formation, irregular joint margin, and/or subchondral cyst;
previous history of knee surgery;
pregnant, breastfeeding, or practicing contraception with reliable methods, or not accepting our guidelines during the research periods;
major pain other than knee joint pain;
current treatment of gastritis or gastric ulcer;
abnormal screening laboratory results;
major cardiac, renal disease, or disability that could affect adverse effect assessment or interfere with study completion when enrolled;
history of major procedures or operations that might affect study results;
enrollment in another clinical trial or human application testing; and
judged as unsuitable for human application testing.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
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Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain
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