Study on clinical efficacy and mechanism of combined acupuncture and medicine for treatment of knee osteoarthritis

Phase 1

Recruiting

• Conditions: Knee osteoarthritis

• Registration Number: ITMCTR2100004561
• Lead Sponsor: Dongzhimen Hospital, Beijing University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients who meet the diagnostic criteria of Western medicine by KOA and meet the syndromes of TCM with yang deficiency or yin deficiency (refer to the Classification and Judgment Criteria for Constitution of Traditional Chinese Medicine issued by the Chinese Society of Traditional Chinese Medicine in 2009 to determine the constitution of KOA patients);
2. 45 years old <= age <= 75 years old, no gender limit;
3. The radiological examination within 6 months shows that the KL classification is I-III;
4. Have not received analgesia or acupuncture within 2 weeks before participating in the trial;
5. Visual analogue scale (VAS)>= 4;
6. Sign the informed consent and volunteer to participate in this research.

Exclusion Criteria

1. Knee pain caused by other diseases, such as knee tuberculosis, tumors, rheumatism and rheumatoid arthritis;
2. Patients with a history of knee surgery;
3. Patients with severe primary diseases of cardiovascular, cerebrovascular, blood, and digestive systems, severely impaired liver and kidney function, and mental illness;
4. Women who are pregnant or breastfeeding, and those who are preparing to become pregnant;
5. It is known to have peptic ulcer or active bleeding, so it is not suitable to take backup medicine;
6. Participating in other clinical studies within the past month will not be allowed to participate in this study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC;

Secondary Outcome Measures

Name	Time	Method
GAD-7;TCM Constitution (yang deficiency and yin deficiency) score;PSQI;Safety index;SF-12;VAS;