Dataset Information

Efficacy and safety of Cortex Eucommiae (Eucommia ulmoides Oliver) extract in subjects with mild osteoarthritis: Study protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled trial.

ABSTRACT: BACKGROUND:Osteoarthritis (OA) is a major degenerative disease that affects the elderly. The global prevalence of OA is increasing annually. However, current treatments are unable to halt the progress of OA. At present, pharmacological treatments such as non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors control the pain; however, there may be side effects to these medications. We hypothesized that Cortex Eucommiae (CE; Eucommia ulmoides Oliver) extract, which is used as a dietary supplement, may slow down or prevent OA. METHODS:This is a protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CE extract in subjects with mild OA. One-hundred subjects with mild OA will be recruited and randomly divided in a 1:1 ratio into 2 groups. One group will receive CE extract for 12 weeks and the other group will receive placebo for 12 weeks. Outcomes will be evaluated by using the visual analog scale (VAS), Korean-Western Ontario and McMaster Universities index (K-WOMAC), Korean-Short Form health survey-36 score (KSF-36), and laboratory test results. DISCUSSION:This clinical trial is expected to provide evidence of the efficacy and safety of CE extract as a treatment for mild OA. TRIAL REGISTRATION:Clinical Trials.gov NCT03744611, registered on November 12, 2018, at https://clinicaltrials.gov/ct2/show/NCT03744611.

SUBMITTER: Ahn HY

PROVIDER: S-EPMC6922360 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Efficacy and safety of Cortex Eucommiae (Eucommia ulmoides Oliver) extract in subjects with mild osteoarthritis: Study protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled trial.

Ahn Hyeon Yeong HY Cho Jae-Heung JH Nam Dongwoo D Kim Eun-Jung EJ Ha In-Hyuk IH

Medicine 20191201 50

<h4>Background</h4>Osteoarthritis (OA) is a major degenerative disease that affects the elderly. The global prevalence of OA is increasing annually. However, current treatments are unable to halt the progress of OA. At present, pharmacological treatments such as non-steroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2 (COX-2) inhibitors control the pain; however, there may be side effects to these medications. We hypothesized that Cortex Eucommiae (CE; Eucommia ulmoides Oliver) extrac ...[more]

PMID: 31852118

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Project description:BACKGROUND: Natural rubber produced by plants, known as polyisoprene, is the most widely used isoprenoid polymer. Plant polyisoprenes can be classified into two types; cis-polyisoprene and trans-polyisoprene, depending on the type of polymerization of the isoprene unit. More than 2000 species of higher plants produce latex consisting of cis-polyisoprene. Hevea brasiliensis (rubber tree) produces cis-polyisoprene, and is the key source of commercial rubber. In contrast, relatively few plant species produce trans-polyisoprene. Currently, trans-polyisoprene is mainly produced synthetically, and no plant species is used for its commercial production. RESULTS: To develop a plant-based system suitable for large-scale production of trans-polyisoprene, we selected a trans-polyisoprene-producing plant, Eucommia ulmoides Oliver, as the target for genetic transformation. A full-length cDNA (designated as EuIPI, Accession No. AB041629) encoding isopentenyl diphosphate isomerase (IPI) was isolated from E. ulmoides. EuIPI consisted of 1028 bp with a 675-bp open reading frame encoding a protein with 224 amino acid residues. EuIPI shared high identity with other plant IPIs, and the recombinant protein expressed in Escherichia coli showed IPI enzymatic activity in vitro. EuIPI was introduced into E. ulmoides via Agrobacterium-mediated transformation. Transgenic lines of E. ulmoides overexpressing EuIPI showed increased EuIPI expression (up to 19-fold that of the wild-type) and a 3- to 4-fold increase in the total content of trans-polyisoprenes, compared with the wild-type (non-transgenic root line) control. CONCLUSIONS: Increasing the expression level of EuIPI by overexpression increased accumulation of trans-polyisoprenes in transgenic E. ulmoides. IPI catalyzes the conversion of isopentenyl diphosphate to its highly electrophilic isomer, dimethylallyl diphosphate, which is the first step in the biosynthesis of all isoprenoids, including polyisoprene. Our results demonstrated that regulation of IPI expression is a key target for efficient production of trans-polyisoprene in E. ulmoides.

Dataset Information

Efficacy and safety of Cortex Eucommiae (Eucommia ulmoides Oliver) extract in subjects with mild osteoarthritis: Study protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled trial.

Publications

Efficacy and safety of Cortex Eucommiae (Eucommia ulmoides Oliver) extract in subjects with mild osteoarthritis: Study protocol for a 12-week, multicenter, randomized, double-blind, placebo-controlled trial.

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