Knee Osteoarthritis (OA)NCT06911437
Clinical Study on the Combination of Xiaoyu Zhitong Formula and Lymphatic Drainage Technique to Improve the Symptoms of Knee Pain and Swelling in Cold Dampness Obstruction Type
An observational study of Knee Osteoarthritis (OA), run by tang jie at 1 site in China.
Trial summary
This research project applies a combination of blood stasis relieving and pain relieving formula and lymphatic drainage technique to treat patients with cold dampness obstruction type knee joint pain. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Knee Osteoarthritis (OA)
- What is being tested?
- treatment group
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2024to 31 Mar 2026
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with cold dampness obstruction type knee joint pain
- Inclusion Criteria:
- a. Patients who meet the diagnostic criteria for knee osteoarthritis in the "Guidelines for Diagnosis and Treatment of Osteoarthritis" (2007 edition) of the Chinese Medical Association Orthopedic Branch and also meet the diagnostic criteria for wind cold dampness syndrome of knee joint obstruction;
- b. Age range: 25-70 years old;
- c.1 week ≤ disease duration ≤ 2 years;
- d. If other treatments have already been received and there is a washout period of more than 14 days;
- e. Voluntarily participate in the study and sign an informed consent form.
- Exclusion Criteria:
- a. Patients with bleeding tendencies severe skin damage or skin diseases in certain areas;
- b. Suspected or diagnosed with tumors;
- c. Patients with severe heart lung brain diseases tuberculosis osteomyelitis and osteoporosis;
- d. Patients with mental illnesses;
- e. Pregnant or planned pregnant women and lactating women;
- f. Have participated in other clinical studies within the past 3 months;
- g. The researchers believe that they are not suitable to participate in this clinical study due to other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Science and Education Department of Changping District Integrated Traditional Chinese and Western Medicine Hospital Beijing.No. 219 Huangping Road Huoying Changping District Beijing
Beijing
About this study
This research project applies a combination of blood stasis relieving and pain relieving formula and lymphatic drainage technique to treat patients with cold dampness obstruction type knee joint pain. The improvement of knee joint pain scores and activity function as well as the degree of soft tissue swelling changes are observed before and after receiving this therapy providing certain ideas for the comprehensive treatment optimization and prognosis judgment of cold dampness obstruction type knee joint pain.
- Conditions
- Knee Osteoarthritis (OA)
- Being tested
- treatment group, control group
- Keywords
- Knee Osteoarthritis, pain, Swelling of soft tissues
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment groupOther
Xiaoyu Zhitong Formula: 10g of long pepper, 10g of cloves, 10g of borneol, 10g of papaya, 10g of white peony, 10g of licorice, 15g of chicken blood vine, 10g psoralen, 10g of cistanche, powdered petroleum jelly, wrapped in gauze and heated and applied to the affected area.
Freehand lymphatic drainage technique: the patient is in the supine position, first use the thumb to press the deep lymph nodes of the trunk for 3-5 min, which are lymph nodes in the groin, neck, lumbosacral spine and supraclavicular fossa, and then perform freehand lymphatic drainage at the lymphatic vessels or superficial lymph nodes, according to the clockwise circle method, all the way to the outside of the thigh, and then to the lateral malleolus of the calf, and then press the medial malleolus of the inner calf to the inner thigh. 20min each time, 1 time every other day. 3 times a week for a total of 9 treatments for 3 weeks.
control groupOther
External application of Diclofenac Diethylamine Emulgel（Manufacturer: Switzerland,Haleon CH SARL） combined with lymphatic drainage technique for treatment，Freehand lymphatic drainage technique: the patient is in the supine position, first use the thumb to press the deep lymph nodes of the trunk for 3-5 min, which are lymph nodes in the groin, neck, lumbosacral spine and supraclavicular fossa, and then perform freehand lymphatic drainage at the lymphatic vessels or superficial lymph nodes, according to the clockwise circle method, all the way to the outside of the thigh, and then to the lateral malleolus of the calf, and then press the medial malleolus of the inner calf to the inner thigh. 20min each time, 1 time every other day. 3 times a week for a total of 9 treatments for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Treatment with Xiaoyu Zhitong Formula combined with lymphatic drainage technique; Receives: Other: treatment group | |
| Control group | External application of Futalin combined with lymphatic drainage technique for treatment Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score
This method is relatively sensitive and comparable. The specific method is to draw a 10 cm horizontal line on the paper with one end of the line marked as 0 indicating no pain; The other end is 10 indicating severe pain; The middle part represents varying degrees of pain. Ask the patient to draw a mark on the horizontal line based on their own feelings to indicate the degree of pain. The pain score is determined by measuring the length of the mark from the 0 point is the pain score.Quantitative score: A higher score indicates a worse outcome, with 0 being no pain and 10 being the most painful.
Measured: Before treatment and at 1 2 3 and 6 weeks after treatment.
Secondary outcomes (2)
Width of soft tissue around joints
Use a tape measure to measure and record at the same position on the knee joint.A lower value indicates a better outcome.
Measured: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
Lysholm knee score scale
Quantitative scoring: Higher scores indicate better outcomes and fewer symptoms or disabilities.
Qualitative scoring:A score of 95 or above is excellent, 94-85 is good, 84-65 is acceptable, and less than 65 is poor.
Measured: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start10 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- tang jie
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, tang jie, Beijing Municipal Health Commission
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911437
- Sponsor's protocol ID
- LunShen(2023)No.09.
- Status last verified
- Mar 2025
- First submitted
- 20 Jan 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Combination of Xiaoyu Zhitong Formula and Lymphatic Drainage Technique to Improve the Symptoms of Knee Pain and Swelling in Cold Dampness Obstruction Type
- ClinicalTrials.gov ID
- NCT06911437
- Acronym / sponsor ID
- LunShen(2023)No.09.
- Conditions
- Knee Osteoarthritis (OA)
- Keywords
- Knee Osteoarthritis, pain, Swelling of soft tissues
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- tang jieOther government
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 4 Apr 2025 (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 research project applies a combination of blood stasis relieving and pain relieving formula and lymphatic drainage technique to treat patients with cold dampness obstruction type knee joint pain. The improvement of knee joint pain scores and activity function as well as the degree of soft tissue swelling changes are observed before and after receiving this therapy providing certain ideas for the comprehensive treatment optimization and prognosis judgment of cold dampness obstruction type knee joint pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Other: treatment groupTreatment with Xiaoyu Zhitong Formula combined with lymphatic drainage technique; |
| Control group | – | Other: control groupExternal application of Futalin combined with lymphatic drainage technique for treatment |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cold dampness obstruction type knee joint pain
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 groupXiaoyu Zhitong Formula: 10g of long pepper, 10g of cloves, 10g of borneol, 10g of papaya, 10g of white peony, 10g of licorice, 15g of chicken blood vine, 10g psoralen, 10g of cistanche, powdered petroleum jelly, wrapped in gauze and heated and applied to the affected area. Freehand lymphatic drainage technique: the patient is in the supine position, first use the thumb to press the deep lymph nodes of the trunk for 3-5 min, which are lymph nodes in the groin, neck, lumbosacral spine and supraclavicular fossa, and then perform freehand lymphatic drainage at the lymphatic vessels or superficial lymph nodes, according to the clockwise circle method, all the way to the outside of the thigh, and then to the lateral malleolus of the calf, and then press the medial malleolus of the inner calf to the inner thigh. 20min each time, 1 time every other day. 3 times a week for a total of 9 treatments for 3 weeks. | Other | Treatment group |
| control groupExternal application of Diclofenac Diethylamine Emulgel（Manufacturer: Switzerland,Haleon CH SARL） combined with lymphatic drainage technique for treatment，Freehand lymphatic drainage technique: the patient is in the supine position, first use the thumb to press the deep lymph nodes of the trunk for 3-5 min, which are lymph nodes in the groin, neck, lumbosacral spine and supraclavicular fossa, and then perform freehand lymphatic drainage at the lymphatic vessels or superficial lymph nodes, according to the clockwise circle method, all the way to the outside of the thigh, and then to the lateral malleolus of the calf, and then press the medial malleolus of the inner calf to the inner thigh. 20min each time, 1 time every other day. 3 times a week for a total of 9 treatments for 3 weeks. | Other | Control group |
Primary outcome
Visual Analogue Score
Time frame: Before treatment and at 1 2 3 and 6 weeks after treatment.
This method is relatively sensitive and comparable. The specific method is to draw a 10 cm horizontal line on the paper with one end of the line marked as 0 indicating no pain; The other end is 10 indicating severe pain; The middle part represents varying degrees of pain. Ask the patient to draw a mark on the horizontal line based on their own feelings to indicate the degree of pain. The pain score is determined by measuring the length of the mark from the 0 point is the pain score.Quantitative score: A higher score indicates a worse outcome, with 0 being no pain and 10 being the most painful.
2 secondary outcomes
Width of soft tissue around joints
Time frame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
Lysholm knee score scale
Time frame: Before treatment and at 1, 2, 3, and 6 weeks after treatment.
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 4 Apr 2025.
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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.
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?
An observational study of Knee Osteoarthritis (OA), run by tang jie 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?
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: enrolling by invitation, as of the sponsor's last update on 4 Apr 2025. 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.
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?
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?
Visual Analogue Score (time frame: Before treatment and at 1 2 3 and 6 weeks after treatment.). 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 4 Apr 2025.