OsteoarthritisNCT03757611
Efficacy and Safety of Tabetri on Osteoarthritis
A study testing Tabetri capsule in people with Osteoarthritis, run by Jaseng Medical Foundation at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Tabetri capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 31 Jul 2017to 15 Jun 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do
Haeundae Jaseng Hospital of Korean Medicine
Busan
Daejeon Jaseng Hospital of Korean Medicine
Daejeon
Jaseng Hospital of Korean Medicine
Seoul
About this study
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
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.
Read the 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).
- Conditions
- Osteoarthritis
- Being tested
- Tabetri capsule, Placebo capsule
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tabetri capsuleDietary supplement
1,000 mg/capsule (Taheebo extract 600 mg/day)
Placebo capsuleDietary supplement
1,000 mg/capsule
| Study group | Role | What they receive |
|---|---|---|
| tabetri | Experimental | Tabetri capsule will be administered orally twice daily for 12 weeks Receives: Dietary Supplement: Tabetri capsule |
| Placebo | Placebo comparator | Placebo capsule will be administered orally twice daily for 12 weeks Receives: Dietary Supplement: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (Visual Analogue Scale)
VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Measured: Change of the week 6 and 12 from baseline
K-WOMAC (Korean-Western Ontario and McMaster Universities)
K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Measured: Change of the week 6 and 12 from baseline
KSF-36 (Korean-Short Form Health Survey 36)
KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning.
Measured: Change of the week 6 and 12 from baseline
Secondary outcomes (4)
Subject's global impression of change scale
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject
Level of Quality
- Excellent (category 1): substantial overall improvement of symptoms
- Good (category 2): overall improvement of symptoms
- Neutral (category 3): no change compared with before
- Worse (category 4): overall deterioration of symptoms
- Very much worse (category 5): substantial overall deterioration of symptoms
Measured: 6 and 12 weeks
Investigator's global impression of change scale
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator
Level of Quality
- Excellent (category 1): substantial overall improvement of symptoms
- Good (category 2): overall improvement of symptoms
- Neutral (category 3): no change compared with before
- Worse (category 4): overall deterioration of symptoms
- Very much worse (category 5): substantial overall deterioration of symptoms
Measured: 6 and 12 weeks
ESR (Erythrocyte sedimentation rate)
ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Measured: Change of the week 12 from baseline
CRP (C-reactive protein)
CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Measured: Change of the week 12 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start31 Jul 2017
- Primary completion13 Mar 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Nutribiotech Co., Ltd., Neonutra
- Responsible party
- Sponsor
- Investigators
- In-Hyuk Ha, KMD, MPH, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757611
- Sponsor's protocol ID
- JS-CT-2017-02
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03757611
- Acronym / sponsor ID
- JS-CT-2017-02
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Collaborators
- Nutribiotech Co., Ltd., Neonutra
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 29 Nov 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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tabetri | Experimental | Dietary Supplement: Tabetri capsuleTabetri capsule will be administered orally twice daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebo capsulePlacebo capsule will be administered orally twice daily for 12 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Tabetri capsule1,000 mg/capsule (Taheebo extract 600 mg/day) | Dietary supplement | tabetri |
| Placebo capsule1,000 mg/capsule | Dietary supplement | Placebo |
Primary outcome
VAS (Visual Analogue Scale)
Time frame: Change of the week 6 and 12 from baseline
VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of "no pain at all" and "worst pain imaginable."
K-WOMAC (Korean-Western Ontario and McMaster Universities)
Time frame: Change of the week 6 and 12 from baseline
K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
KSF-36 (Korean-Short Form Health Survey 36)
Time frame: Change of the week 6 and 12 from baseline
KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning.
4 secondary outcomes
Subject's global impression of change scale
Time frame: 6 and 12 weeks
Investigator's global impression of change scale
Time frame: 6 and 12 weeks
ESR (Erythrocyte sedimentation rate)
Time frame: Change of the week 12 from baseline
CRP (C-reactive protein)
Time frame: Change of the week 12 from baseline
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 30 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
In-Hyuk Ha, KMD, MPH principal investigator
Jaseng Medical Foundation
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tabetri capsule in people with Osteoarthritis, run by Jaseng Medical Foundation at 4 sites in South Korea.
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 17 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 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?
VAS (Visual Analogue Scale) (time frame: Change of the week 6 and 12 from baseline). The study lists 3 primary outcomes in all. 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 30 Nov 2018.