Clinical trial NCT03757611: Efficacy and Safety of Tabetri on Osteoarthritis
Official title: A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Tabetri on Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
Collaborators: name: Nutribiotech Co., Ltd.
name: Neonutra
First posted: 2018-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.

Detailed description: This study is prospectively conducted to investigate the efficacy and safety of tabetri in patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Haeundae, Daejeon, and Bucheon).

Eligibility criteria: Inclusion Criteria:

* Male or female 40 \~ 75 years of age
* VAS (Visual Analogue Scale) over 30mm
* Kellgren \& Lawrence Grade I\~II by X-ray
* Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)

Exclusion Criteria:

* Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthritis, gout)
* Joint space under 2 mm by X-ray
* Kellgren \& Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray
* Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases
* Subjects having gastrointestinal diseases
* Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
* Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl)
* Patients with TSH \<= 0.1 uIU/mL or \>= 10 uIU/mL
* Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values)
* Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values)
* Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
* Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening
* Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
* History of osteoarthritis treatment therapy within 2 weeks prior to screening
* Have participated in another clinical trial within the 3 months prior to screening
* Subjects who have hypersensitivity history about investigational product
* Have difficulty to be participated in this clinical trial by investigator's decision

Primary outcomes:
measure: VAS (Visual Analogue Scale)
timeFrame: Change of the week 6 and 12 from baseline
measure: K-WOMAC (Korean-Western Ontario and McMaster Universities)
timeFrame: Change of the week 6 and 12 from baseline
measure: KSF-36 (Korean-Short Form Health Survey 36)
timeFrame: Change of the week 6 and 12 from baseline
Secondary outcomes:
measure: Subject's global impression of change scale
timeFrame: 6 and 12 weeks
measure: Investigator's global impression of change scale
timeFrame: 6 and 12 weeks
measure: ESR (Erythrocyte sedimentation rate)
timeFrame: Change of the week 12 from baseline
measure: CRP (C-reactive protein)
timeFrame: Change of the week 12 from baseline
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Medical Foundation
name: In-Hyuk Ha, KMD, MPH
role: PRINCIPAL_INVESTIGATOR
References: