Knee OsteoarthritisPhase 3NCT03418155
Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis
A Phase 3 study testing Treatment of TongBi Capsule in people with Knee Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule in combination,while the other half will receive a Placebo. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Treatment of TongBi Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Oct 2019
- Phase
- Phase 3
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.45-75 years of age (including 45 years and 75 years old), men and women are not limited.
- 2. western medicine diagnosis of knee osteoarthritis, clinical classification for primary.
- 3.The severity of the imaging classification of K-L≤Ⅲ; 4. treatment VAS pain scores than 40mm (select the subjects most obvious limb pain symptoms).
- 5. informed consent form signed by the patient or legal representative.
Who cannot join
- within 3 months prior to the trial, the patients were treated within intra-articular treatment.
- 4 weeks before the treatment, corticosteroids, non steroidal drugs, intra-articular injections or other drugs to improve the condition (such as cartilage protective agents) were used.
- The screening period has any disease history or evidence:
- The basic of serious cardiovascular and cerebrovascular diseases; An active, recurrent peptic ulcer or other hemorrhagic disease risk; Sales and other serious diseases of digestive system; An associated with malignant tumors, blood, or other serious diseases or system; Patients who are unable to cooperate or cooperate with other mental disorders.
- Before the screening, any laboratory test indicators meet the following standards:
- An admission of liver and kidney function showed that ALT and AST is more than 1.5 times the upper limit of the normal value, Cr is more than 1.2 times the upper limit of normal (Reference Research Center laboratory where the range of normal value); An other clinically significant laboratory abnormalities, and the researchers judged not into the group.
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- Allergic constitution or allergic to TongBi capsul, excipients or similar ingredients;
- Professional athletes;
- doubt or indeed history of alcohol and drug abuse;
- participants who participated in other clinical trials within the first 3 months;
- the researchers believe that patients should not participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100052
About this study
Official title: Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis:a Randomized, Double-blind, Placebo-controlled Post - Market Clinical Study
This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule in combination,while the other half will receive a Placebo.
- Conditions
- Knee Osteoarthritis
- Being tested
- Treatment of TongBi Capsule, Treatment of TongBi placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of TongBi CapsuleDrug
Also called capsule A
TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.
Treatment of TongBi placeboDrug
TongBi placebo:0.31g,3times a day, oral, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of TongBi Capsule | Experimental | Not described Receives: Drug: Treatment of TongBi Capsule |
| Treatment of TongBi Placebo | Placebo comparator | Not described Receives: Drug: Treatment of TongBi placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from Baseline to week 4 in Visual Analog Scale (VAS)score
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
Measured: 0 weeks,2 weeks，4 weeks
Secondary outcomes (3)
The change from Baseline to week 4 in Western Ontarioand McMaster Universities
WOMAC scores ranges from 0 to 96, with higher scores indicating greater disability
Measured: 0 weeks,2 weeks and 4 weeks
The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores
SF-36 scores ranges from 0 to 100,it shows the extent of physical function
Measured: 0 weeks,4 weeks
The number of adverse events
The number of adverse events related to treatment.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Feb 2018 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiang Quan, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418155
- Sponsor's protocol ID
- BH_2016001
- Status last verified
- Jan 2018
- First submitted
- 25 Jan 2018
- Last updated
- 1 Feb 2018
- 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 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis:a Randomized, Double-blind, Placebo-controlled Post - Market Clinical Study
- ClinicalTrials.gov ID
- NCT03418155
- Acronym / sponsor ID
- BH_2016001
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2018 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Oct 2019 (estimated)
- First posted
- 1 Feb 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 evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule in combination,while the other half will receive a Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of TongBi Capsule | Experimental | Drug: Treatment of TongBi Capsule |
| Treatment of TongBi Placebo | Placebo comparator | Drug: Treatment of TongBi placebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1.45-75 years of age (including 45 years and 75 years old), men and women are not limited.
- 2. western medicine diagnosis of knee osteoarthritis, clinical classification for primary.
- 3.The severity of the imaging classification of K-L≤Ⅲ; 4. treatment VAS pain scores than 40mm (select the subjects most obvious limb pain symptoms).
- 5. informed consent form signed by the patient or legal representative.
Key exclusion criteria (11 listed)
- within 3 months prior to the trial, the patients were treated within intra-articular treatment.
- 4 weeks before the treatment, corticosteroids, non steroidal drugs, intra-articular injections or other drugs to improve the condition (such as cartilage protective agents) were used.
- The screening period has any disease history or evidence:
- The basic of serious cardiovascular and cerebrovascular diseases; An active, recurrent peptic ulcer or other hemorrhagic disease risk; Sales and other serious diseases of digestive system; An associated with malignant tumors, blood, or other serious diseases or system; Patients who are unable to cooperate or cooperate with other mental disorders.
- Before the screening, any laboratory test indicators meet the following standards:
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 |
|---|---|---|
| Treatment of TongBi CapsuleAlso: capsule ATongBi Capsule:0.31g,3times a day, oral, for 4 weeks. | Drug | Treatment of TongBi Capsule |
| Treatment of TongBi placeboTongBi placebo:0.31g,3times a day, oral, for 4 weeks. | Drug | Treatment of TongBi Placebo |
Primary outcome
The change from Baseline to week 4 in Visual Analog Scale (VAS)score
Time frame: 0 weeks,2 weeks，4 weeks
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
3 secondary outcomes
The change from Baseline to week 4 in Western Ontarioand McMaster Universities
Time frame: 0 weeks,2 weeks and 4 weeks
The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores
Time frame: 0 weeks,4 weeks
The number of adverse events
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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.
Jiang Quan principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment of TongBi Capsule in people with Knee Osteoarthritis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Quan (86-010-88001060, doctorjq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from Baseline to week 4 in Visual Analog Scale (VAS)score (time frame: 0 weeks,2 weeks，4 weeks). 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 1 Feb 2018.