Knee Osteoarthritis (Knee OA)Phase 4NCT06674759
Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis
A Phase 4 study testing Tongren-Dahuoluo Bolus in people with Knee Osteoarthritis (Knee OA), run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
The clinical trial has a research cycle of 24 weeks. The first 12 weeks are multicenter, randomized, double-blind, controlled trials. A total of 72 patients with knee osteoarthritis with liver-kidney deficiency syndrome and/or cold-dampness arthralgia syndrome are planned to be enrolled and randomly assigned to the… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Tongren-Dahuoluo Bolus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2025to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 40 to 75 years old;
- Meet the diagnostic criteria for primary knee osteoarthritis (KOA) (the diagnostic criteria refer to the 1995 American College of Rheumatology classification criteria for knee osteoarthritis);
- Meet the diagnostic criteria for liver and kidney deficiency and (or) cold and dampness obstruction in the group standard of the Chinese Association of Traditional Chinese Medicine "Guidelines for Combination of Osteoarthritis Symptoms";
- X-ray examination of the joints is graded as I to III (knee joint Kellgren/Lawrence e scoring standard);
- Knee pain score ≥40mm in the past week (assessed by VAS standard);
Who cannot join
- Patients with other rheumatic diseases such as Sjögren's syndrome, gout, rheumatoid arthritis, or a history of human immunodeficiency virus (HIV);
- Patients with severe lesions of important organs such as the heart, liver, and kidney, abnormal liver function (alanine or aspartate aminotransferase or glutamine transpeptidase>1.5 times the upper limit of normal value); or abnormal renal function (serum creatinine level> upper limit of normal value); white blood cell (white blood cell, WBC) or platelet (platelet, PLT) below the lower limit of normal value; or diabetic patients with poor blood sugar control in the recent period (glycosylated hemoglobin>8.0%);
- Patients with suppurative, nonspecific, and other infectious knee arthritis;
- Patients with traumatic, villonodular pigmentation and other lesions with knee synovium as the main lesions;
- Patients with advanced joint deformity or disability; A randomized controlled study on Tongren Dahuoluowan in the treatment of knee osteoarthritis Version number: 2023009P8A01 Version date: December 23, 2022
- Allergic constitution and allergic to the test drug;
Show all 12Show fewer
- Pregnant, pregnant, or lactating women;
- Those who are taking antidepressants, anticonvulsants, opioids, sedatives and glucocorticoids;
- Patients who have received intra-articular treatment with sodium hyaluronate within 4 weeks before screening; those who have taken drugs containing chondroitin sulfate/glucosamine/diacerein within 3 months before screening; those who have used biological agents within 3 months before screening;
- Patients with organ failure symptoms;
- Those who have participated in any other drug trials within 1 month before selection;
- Those who the researcher believes are not eligible to join this clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Study
The clinical trial has a research cycle of 24 weeks. The first 12 weeks are multicenter, randomized, double-blind, controlled trials. A total of 72 patients with knee osteoarthritis with liver-kidney deficiency syndrome and/or cold-dampness arthralgia syndrome are planned to be enrolled and randomly assigned to the control group (Tongren-Dahuoluo Bolus) and the treatment group (Tongren-Dahuoluo Bolus Placebo) in a 1:1 ratio. The purpose is to compare the safety and efficacy of Tongren-Dahuoluo Bolus and placebo in treating knee osteoarthritis. A long-term blind extension study will be conducted in the next 12 weeks. All subjects will take Tongren-Dahuoluo Bolus orally to evaluate the long-term safety, tolerability, and efficacy of Tongren-Dahuoluo Pills in treating patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Tongren-Dahuoluo Bolus, Tongren-Dahuoluo Bolus Placebo
- Keywords
- Tongren-Dahuoluo Bolus, Knee osteoarthritis (Knee OA)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongren-Dahuoluo BolusDrug
0.72g,2 times a day, oral, for 24 weeks.
Tongren-Dahuoluo Bolus PlaceboDrug
0.72g,2 times a day, oral, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Tongren Dahuoluo Pills | Experimental | Not described Receives: Drug: Tongren-Dahuoluo Bolus |
| Treatment of Tongren-Dahuoluo Bolus Placebo | Placebo comparator | Not described Receives: Drug: Tongren-Dahuoluo Bolus Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline to week 24 in Visual Analog Scale (VAS)score
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Secondary outcomes (8)
Changes in the 30s-CST frequency (30-second chair sit-stand test) of the experimental group relative to the baseline and control group at the 4th, 12th, and 24th weeks;
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in knee osteoarthritis index (WOMAC score) at week 4, week 12, and week 24 relative to baseline and control group
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in TCM syndrome score evaluation at week 4, week 12, and week 24 relative to baseline and control group;
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in KOOS scores of knee injury and osteoarthritis outcomes at weeks 4, 12, and 24 relative to baseline and the control group
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in SF-12 at week 4, week 12, and week 24 relative to baseline and control group
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (CRP) relative to baseline and control group at week 4, week 12, and week 24
CRP in μg/L
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (ESR) relative to baseline and control group at week 4, week 12, and week 24
ESR in mm/h
Measured: 0 weeks, 4 weeks,12 weeks, 24 weeks
MRI examination of the knee joint (target joint) at the time of enrollment and at week 24 to examine the changes in bone marrow edema, joint effusion, synovitis, cartilage volume and composition relative to the baseline and control group
Measured: 0 week, 4 weeks,12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start10 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674759
- Sponsor's protocol ID
- 2023-170-YW-01
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical Considerations: Adhering to ethical guidelines that prioritize patient consent and data protection. Lack of Consent: Patients may not have consented to share their data publicly.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06674759
- Acronym / sponsor ID
- 2023-170-YW-01
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Tongren-Dahuoluo Bolus, Knee osteoarthritis (Knee OA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Nov 2024 (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.
The clinical trial has a research cycle of 24 weeks. The first 12 weeks are multicenter, randomized, double-blind, controlled trials. A total of 72 patients with knee osteoarthritis with liver-kidney deficiency syndrome and/or cold-dampness arthralgia syndrome are planned to be enrolled and randomly assigned to the control group (Tongren-Dahuoluo Bolus) and the treatment group (Tongren-Dahuoluo Bolus Placebo) in a 1:1 ratio. The purpose is to compare the safety and efficacy of Tongren-Dahuoluo Bolus and placebo in treating knee osteoarthritis. A long-term blind extension study will be conducted in the next 12 weeks. All subjects will take Tongren-Dahuoluo Bolus orally to evaluate the long-term safety, tolerability, and efficacy of Tongren-Dahuoluo Pills in treating patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of Tongren Dahuoluo Pills | Experimental | Drug: Tongren-Dahuoluo Bolus |
| Treatment of Tongren-Dahuoluo Bolus Placebo | Placebo comparator | Drug: Tongren-Dahuoluo Bolus Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, aged 40 to 75 years old;
- Meet the diagnostic criteria for primary knee osteoarthritis (KOA) (the diagnostic criteria refer to the 1995 American College of Rheumatology classification criteria for knee osteoarthritis);
- Meet the diagnostic criteria for liver and kidney deficiency and (or) cold and dampness obstruction in the group standard of the Chinese Association of Traditional Chinese Medicine "Guidelines for Combination of Osteoarthritis Symptoms";
- X-ray examination of the joints is graded as I to III (knee joint Kellgren/Lawrence e scoring standard);
- Knee pain score ≥40mm in the past week (assessed by VAS standard);
Key exclusion criteria (12 listed)
- Patients with other rheumatic diseases such as Sjögren's syndrome, gout, rheumatoid arthritis, or a history of human immunodeficiency virus (HIV);
- Patients with severe lesions of important organs such as the heart, liver, and kidney, abnormal liver function (alanine or aspartate aminotransferase or glutamine transpeptidase>1.5 times the upper limit of normal value); or abnormal renal function (serum creatinine level> upper limit of normal value); white blood cell (white blood cell, WBC) or platelet (platelet, PLT) below the lower limit of normal value; or diabetic patients with poor blood sugar control in the recent period (glycosylated hemoglobin>8.0%);
- Patients with suppurative, nonspecific, and other infectious knee arthritis;
- Patients with traumatic, villonodular pigmentation and other lesions with knee synovium as the main lesions;
- Patients with advanced joint deformity or disability; A randomized controlled study on Tongren Dahuoluowan in the treatment of knee osteoarthritis Version number: 2023009P8A01 Version date: December 23, 2022
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 |
|---|---|---|
| Tongren-Dahuoluo Bolus0.72g,2 times a day, oral, for 24 weeks. | Drug | Treatment of Tongren Dahuoluo Pills |
| Tongren-Dahuoluo Bolus Placebo0.72g,2 times a day, oral, for 12 weeks. | Drug | Treatment of Tongren-Dahuoluo Bolus Placebo |
Primary outcome
Changes from Baseline to week 24 in Visual Analog Scale (VAS)score
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
8 secondary outcomes
Changes in the 30s-CST frequency (30-second chair sit-stand test) of the experimental group relative to the baseline and control group at the 4th, 12th, and 24th weeks;
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in knee osteoarthritis index (WOMAC score) at week 4, week 12, and week 24 relative to baseline and control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in TCM syndrome score evaluation at week 4, week 12, and week 24 relative to baseline and control group;
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in KOOS scores of knee injury and osteoarthritis outcomes at weeks 4, 12, and 24 relative to baseline and the control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in SF-12 at week 4, week 12, and week 24 relative to baseline and control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (CRP) relative to baseline and control group at week 4, week 12, and week 24
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (ESR) relative to baseline and control group at week 4, week 12, and week 24
Time frame: 0 weeks, 4 weeks,12 weeks, 24 weeks
MRI examination of the knee joint (target joint) at the time of enrollment and at week 24 to examine the changes in bone marrow edema, joint effusion, synovitis, cartilage volume and composition relative to the baseline and control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No. Ethical Considerations: Adhering to ethical guidelines that prioritize patient consent and data protection. Lack of Consent: Patients may not have consented to share their data publicly.
Related trials for Knee Osteoarthritis (Knee OA)
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
Obesity, Overweight
RecruitingPhase 3
A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
Obesity, Overweight and/or Obesity
Not yet recruiting
Boosting Exercise Adherence in Knee Osteoarthritis
Osteoarthritis, Knee
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongren-Dahuoluo Bolus in people with Knee Osteoarthritis (Knee OA), run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
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 5 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Jiang (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?
Changes from Baseline to week 24 in Visual Analog Scale (VAS)score (time frame: 0 week, 4 weeks,12 weeks, 24 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 5 Nov 2024.