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Clinical study of huaizhen Yanggan capsule in the treatment of knee osteoarthritis

A randomized, double-blind, placebo-controlled clinical trial of Huaizhen Yanggan capsule in the treatment of knee osteoarthritis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003696
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis

Interventions

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Patients with knee osteoarthritis who meet the diagnostic criteria of Western medicine and TCM syndrome differentiation; (2) Aged 40-70 years old male and female; (3) KL grade was 0-3; (4) VAS score >=4; (5) The subjects had informed consent and signed the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) KL grade 4; (2) Other inflammatory and painful diseases of knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, tumor, joint trauma, suppurative arthritis, etc; (3) Knee osteoarthritis caused by osteomyelitis, bone tumor and bone tuberculosis; (4) Patients with pyogenic and nonspecific infectious knee osteoarthritis were found; (5) The patients with advanced joint deformity or disability; (6) Intra articular treatment including intra-articular injection of drugs, intra-articular irrigation and arthroscopic surgery were performed within 3 months before the trial; (7) Patients with multiple lower extremity osteoarthritis of hip, knee and ankle had lower limb pain due to the onset of lumbar degenerative disease; (8) Alt >=1.5 ULN, abnormal Cr contration; (9) Pregnant or lactating women; (10) People with allergic constitution or allergic to this drug; (11) Patients with severe cardiovascular and cerebrovascular diseases, blood system, liver, gastrointestinal tract, kidney disease and diabetes mellitus; (12) Mental patients; (13) Those who have used hormone therapy within one month; (14) Those who have used other drugs for the treatment of knee osteoarthritis within one week before the trial, such as non steroidal anti-inflammatory drugs, benzothiazides, glucosamine, chondroitin sulfate and related traditional Chinese medicine; (15) Long term use of other drugs that affect the efficacy and safety of the trial drug and take comprehensive treatment; (16) Patients who have participated in other clinical trials within three months; (17) The researchers consider that it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
VAS score;WOMAC total score and pain score;

Secondary

MeasureTime frame
WOMAC stiffness score, joint activity score;

Countries

China

Contacts

Public ContactGuo Hailing

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

ghl22007190@163.com+86 13764074533

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026