Osteoarthritis of the KneeEarly Phase 1NCT06451783
Shengyu Decoction and Lijin Manipulation for Knee OA: 3D Gait Analysis
A Early Phase 1 study testing Traditional Chinese medicine combined with manipulation treatment and Celecoxib capsule in people with Osteoarthritis of the Knee, run by Xuhui Central Hospital, Shanghai at 1 site in China.
Trial summary
Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Traditional Chinese medicine combined with manipulation treatment and Celecoxib capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic criteria of Western medicine: Knee pain for at least 1 month, X-ray showing osteophyte formation, age ≥50 years, morning stiffness ≤30 min, and bone fricative sound.
- TCM diagnostic criteria: Dull pain in the knee joint, flexion and extension limitations, pitching and side rotation unfavorability, slight activities slightly relieve pain, climate change aggravates symptoms, and repeated middle-aged and elderly patients, hidden onset, slow onset, slight local swelling of the knee joint, friction or clicking sound when moving, and severe cases may show muscle atrophy and joint deformity.
- Radiographs showing joint space narrowing, bone hyperplasia, subchondral osteosclerosis, and osteophyte formation.
- Patients who are between 45 and 85 years old.
- Patients who can understand and provide informed consent.
- Patients who are willing and able to undergo manual treatment for 1 course of treatment and cooperate with the doctor to complete the study.
Who cannot join
- Patients who do not meet the diagnostic criteria for knee osteoarthritis established by the rheumatology society.
- Severe knee pain with surgical indications (or X-ray grading standards reached level 4).
- Pregnant or planning to become pregnant.
- Patients who have participated in or are participating in other clinical trials within the last 3 months.
- Patients who have received or are receiving other treatment methods such as drugs that affect the evaluation of efficacy within the past 3 months.
- Patients with fractures, dislocation, skin damage, and severe infectious skin diseases within three weeks.
- Patients with severe primary diseases such as liver, kidney, hematopoietic system, endocrine system, cardiovascular and cerebrovascular, nervous system, tuberculosis, joint malformations, tumors, and psychiatric patients and postoperative patients.
- Patients who are unable to accurately evaluate the effectiveness and safety of treatment due to their medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Efficacy of Shengyu Decoction Combined With Lijin Manipulation in the Treatment of Knee Osteoarthritis Was Observed Based on Three-dimensional Gait Analysis System
Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.
Read the detailed description
This study aims to explore the efficacy of the Shengyu Decoction combined with manual therapy for the treatment of knee osteoarthritis (OA) using a clinical randomized controlled trial design. Additionally, based on three-dimensional gait analysis technology, the investigators will delve into the biomechanical mechanisms underlying the onset of knee OA and elucidate the mechanism of action of the Shengyu Decoction combined with manual therapy. This will further validate the clinical superiority of the Shengyu Decoction combined with manual therapy in the treatment of knee OA, providing strong support for reducing pain and improving knee function in patients with knee OA.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Traditional Chinese medicine combined with manipulation treatment, Celecoxib capsule
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine combined with manipulation treatmentOther
The specific procedure involves administering the Shengyu Decoction, which consists of the following herbs:
- Shu Di Huang 20 grams
- Bai Shao 15 grams
- Dang Gui 15 grams
- Chuan Xiong 8 grams
- Ren Shen 20 grams
- Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks. Add manipulation of massage：
- Press and grasp the affected limb three times；
- Five-finger five-acupoint pressing method；
- Point pressing on Zusanli (ST36) and Sanyinjiao (SP6)；
- grasp the interior method to treat the calf three times； ⑤ Apply rolling technique around the knee joint； ⑥ Knead and straighten the standing tendon (the lateral muscle of the calf)； ⑦ Six-finger six-acupoint pressing method； ⑧ Push and pull the patella to flex and extend the knee joint； ⑨ Knee joint reunion and smooth dispersion method.
Celecoxib capsuleDrug
Oral Celecoxib Capsules, 200mg per dose, once daily after lunch.
| Study group | Role | What they receive |
|---|---|---|
| Combined treatment group | Experimental | Traditional Chinese medicine combined with manipulation treatment：the Shengyu Decoction, which consists of the following herbs:
* Shu Di Huang 20 grams
* Bai Shao 15 grams
* Dang Gui 15 grams
* Chuan Xiong 8 grams
* Ren Shen 20 grams
* Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks. Receives: Other: Traditional Chinese medicine combined with manipulation treatment |
| Control group | Active comparator | Oral control group medication： Oral Celecoxib Capsules, 200mg per dose, once daily after lunch. Receives: Drug: Celecoxib capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The western Ontario and McMaster universities osteoarthritis index
The WOMAC consists of a series of questions that capture the patient's perception of pain, stiffness, and physical function over the past week. It is scored on a numerical scale, with higher scores indicating greater impairment. The index is often used in clinical trials and epidemiological studies to measure changes in osteoarthritis symptoms and to assess the effectiveness of treatments.
Measured: up to 13 weeks
Secondary outcomes (3)
Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis
Stride Length in meters
Measured: up to 13 weeks
Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis
Walking Speed in meters per second
Measured: up to 13 weeks
Gait Speed in meters per second
Gait Analysis
Measured: up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 May 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Combined treatment group：Traditional Chinese medicine combined with manipulation treatment Control group：Oral control group medication
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuhui Central Hospital, Shanghai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liang Qiao, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451783
- Sponsor's protocol ID
- XuhuiCH202405
- Status last verified
- Jun 2024
- First submitted
- 15 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Shengyu Decoction Combined With Lijin Manipulation in the Treatment of Knee Osteoarthritis Was Observed Based on Three-dimensional Gait Analysis System
- ClinicalTrials.gov ID
- NCT06451783
- Acronym / sponsor ID
- XuhuiCH202405
- Conditions
- Osteoarthritis of the Knee
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Xuhui Central Hospital, ShanghaiUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jun 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.
Detailed Description Avoid duplicating information that will be entered or uploaded elsewhere in the record.
Detailed description
This study aims to explore the efficacy of the Shengyu Decoction combined with manual therapy for the treatment of knee osteoarthritis (OA) using a clinical randomized controlled trial design. Additionally, based on three-dimensional gait analysis technology, the investigators will delve into the biomechanical mechanisms underlying the onset of knee OA and elucidate the mechanism of action of the Shengyu Decoction combined with manual therapy. This will further validate the clinical superiority of the Shengyu Decoction combined with manual therapy in the treatment of knee OA, providing strong support for reducing pain and improving knee function in patients with knee OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Combined treatment group：Traditional Chinese medicine combined with manipulation treatment Control group：Oral control group medication
| Arm | Type | Receives |
|---|---|---|
| Combined treatment group | Experimental | Other: Traditional Chinese medicine combined with manipulation treatmentTraditional Chinese medicine combined with manipulation treatment：the Shengyu Decoction, which consists of the following herbs: * Shu Di Huang 20 grams * Bai Shao 15 grams * Dang Gui 15 grams * Chuan Xiong 8 grams * Ren Shen 20 grams * Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks. |
| Control group | Active comparator | Drug: Celecoxib capsuleOral control group medication： Oral Celecoxib Capsules, 200mg per dose, once daily after lunch. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnostic criteria of Western medicine: Knee pain for at least 1 month, X-ray showing osteophyte formation, age ≥50 years, morning stiffness ≤30 min, and bone fricative sound.
- TCM diagnostic criteria: Dull pain in the knee joint, flexion and extension limitations, pitching and side rotation unfavorability, slight activities slightly relieve pain, climate change aggravates symptoms, and repeated middle-aged and elderly patients, hidden onset, slow onset, slight local swelling of the knee joint, friction or clicking sound when moving, and severe cases may show muscle atrophy and joint deformity.
- Radiographs showing joint space narrowing, bone hyperplasia, subchondral osteosclerosis, and osteophyte formation.
- Patients who are between 45 and 85 years old.
- Patients who can understand and provide informed consent.
Key exclusion criteria (8 listed)
- Patients who do not meet the diagnostic criteria for knee osteoarthritis established by the rheumatology society.
- Severe knee pain with surgical indications (or X-ray grading standards reached level 4).
- Pregnant or planning to become pregnant.
- Patients who have participated in or are participating in other clinical trials within the last 3 months.
- Patients who have received or are receiving other treatment methods such as drugs that affect the evaluation of efficacy within the past 3 months.
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 |
|---|---|---|
| Traditional Chinese medicine combined with manipulation treatmentThe specific procedure involves administering the Shengyu Decoction, which consists of the following herbs: * Shu Di Huang 20 grams * Bai Shao 15 grams * Dang Gui 15 grams * Chuan Xiong 8 grams * Ren Shen 20 grams * Huang Qi 18 grams One dose is taken per day, and a course of treatment consists of five weeks. Add manipulation of massage： * Press and grasp the affected limb three times； * Five-finger five-acupoint pressing method； * Point pressing on Zusanli (ST36) and Sanyinjiao (SP6)； * grasp the interior method to treat the calf three times； ⑤ Apply rolling technique around the knee joint； ⑥ Knead and straighten the standing tendon (the lateral muscle of the calf)； ⑦ Six-finger six-acupoint pressing method； ⑧ Push and pull the patella to flex and extend the knee joint； ⑨ Knee joint reunion and smooth dispersion method. | Other | Combined treatment group |
| Celecoxib capsuleOral Celecoxib Capsules, 200mg per dose, once daily after lunch. | Drug | Control group |
Primary outcome
The western Ontario and McMaster universities osteoarthritis index
Time frame: up to 13 weeks
The WOMAC consists of a series of questions that capture the patient's perception of pain, stiffness, and physical function over the past week. It is scored on a numerical scale, with higher scores indicating greater impairment. The index is often used in clinical trials and epidemiological studies to measure changes in osteoarthritis symptoms and to assess the effectiveness of treatments.
3 secondary outcomes
Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis
Time frame: up to 13 weeks
Measurement of Gait Dynamics Parameters in Patients with Knee Osteoarthritis
Time frame: up to 13 weeks
Gait Speed in meters per second
Time frame: up to 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis of the Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Traditional Chinese medicine combined with manipulation treatment and Celecoxib capsule in people with Osteoarthritis of the Knee, run by Xuhui Central Hospital, Shanghai 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 6 inclusion and 8 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 11 Jun 2024. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
The western Ontario and McMaster universities osteoarthritis index (time frame: up to 13 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 11 Jun 2024.