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Clinical Trials in China / NCT06911437
Enrolling by invitation Observational

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

NCT06911437 · tracked via the Priya Life Science China tracker
Sponsor
tang jie
Phase
Observational
Started
2024-10-10
Last updated
2025-04-04

Condition(s) studied

Knee Osteoarthritis (OA)

Investigational drug(s) / intervention(s)

treatment groupcontrol group

treatment group: 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 group: 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 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. 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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
70 Years
Healthy volunteers
No
1. 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. 2. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Science and Education Department of Changping District Integrated Traditional Chinese and Western Medicine Hospital Beijing.No. 219 Huangping Road Huoying Changping District Beijing Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06911437 on ClinicalTrials.gov ↗ ← All trials in China