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Effect of Cis-9-cetylmyristoleate in Sub-healthy Subjects Presenting With Knee Joint Pain

S

Seoul National University

Status

Completed

Conditions

Knee Pain Intermittent

Treatments

Dietary Supplement: Starch 100%
Dietary Supplement: 80% dose of JOINTRUS®
Dietary Supplement: JOINTRUS®
Dietary Supplement: 62.4% dose of JOINTRUS®

Study type

Interventional

Funder types

Other

Identifiers

NCT02800759
1307-098-506

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

28 participants in 4 patient groups, including a placebo group

100% of JOINTRUS®
Active Comparator group
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.
Treatment:
Dietary Supplement: JOINTRUS®
80% of JOINTRUS®
Active Comparator group
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.
Treatment:
Dietary Supplement: 80% dose of JOINTRUS®
62.4% of JOINTRUS®
Active Comparator group
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.
Treatment:
Dietary Supplement: 62.4% dose of JOINTRUS®
Starch 100%
Placebo Comparator group
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.
Treatment:
Dietary Supplement: Starch 100%

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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