OsteoarthritisNCT04267432
The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
A study testing TCI633 and Type 2 collagen in people with Osteoarthritis, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- TCI633 and Type 2 collagen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2018to 12 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)
- Without heart, liver, kidney, endocrine and other major organic diseases (patient return)
Who cannot join
- With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return)
- People with mental illness
Trial locations and contacts
1 site in 1 country.
About this study
To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis
Read the detailed description
This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.
- Conditions
- Osteoarthritis
- Being tested
- Placebo, TCI633, Type 2 collagen
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Blank
TCI633Dietary supplement
Probiotics
Type 2 collagenDrug
Positive control group
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
| TCI633 | Experimental | Testing product Receives: Dietary Supplement: TCI633 |
| Type 2 collagen | Active comparator | Known drug for OA Receives: Drug: Type 2 collagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
KL Grade (evaluated by doctor)
Pain relief and functional improvement in osteoarthritis
Measured: Change from baseline at 6 months
WOMAC™ Osteoarthritis Index
The questionnaire includes three-part: i) join pain (five questions); ii) joint stiffness (two questions); and, iii) physical functions of joints (seventeen questions). Each question is scored 0-4. Low to high WOMAC scores represent slight to severe OA symptoms. The lower scores mean a better outcome.
Measured: Change from baseline at 6 months
Secondary outcomes (2)
Blood C-terminal telopeptide of collagen type II (CTX-II) level
To measure the level of CTX-II in blood
Measured: Change from baseline at 6 months
Blood C-reactive protein (CRP) level
To measure the level of CRP in blood
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start28 Mar 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ting-Ming Wang, Doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267432
- Sponsor's protocol ID
- 201703132MSC
- Status last verified
- Feb 2020
- First submitted
- 6 Jan 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
- ClinicalTrials.gov ID
- NCT04267432
- Acronym / sponsor ID
- 201703132MSC
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 12 Feb 2020 (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.
To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis
Detailed description
This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
| TCI633 | Experimental | Dietary Supplement: TCI633Testing product |
| Type 2 collagen | Active comparator | Drug: Type 2 collagenKnown drug for OA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)
- Without heart, liver, kidney, endocrine and other major organic diseases (patient return)
Key exclusion criteria (2 listed)
- With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return)
- People with mental illness
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 |
|---|---|---|
| PlaceboBlank | Dietary supplement | Placebo |
| TCI633Probiotics | Dietary supplement | TCI633 |
| Type 2 collagenPositive control group | Drug | Type 2 collagen |
Primary outcome
KL Grade (evaluated by doctor)
Time frame: Change from baseline at 6 months
Pain relief and functional improvement in osteoarthritis
WOMAC™ Osteoarthritis Index
Time frame: Change from baseline at 6 months
The questionnaire includes three-part: i) join pain (five questions); ii) joint stiffness (two questions); and, iii) physical functions of joints (seventeen questions). Each question is scored 0-4. Low to high WOMAC scores represent slight to severe OA symptoms. The lower scores mean a better outcome.
2 secondary outcomes
Blood C-terminal telopeptide of collagen type II (CTX-II) level
Time frame: Change from baseline at 6 months
Blood C-reactive protein (CRP) level
Time frame: Change from baseline at 6 months
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 12 Feb 2020.
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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.
Ting-Ming Wang, Doctor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCI633 and Type 2 collagen in people with Osteoarthritis, run by TCI Co., Ltd. at 1 site in Taiwan.
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 2 inclusion and 2 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
KL Grade (evaluated by doctor) (time frame: Change from baseline at 6 months). The study lists 2 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 12 Feb 2020.