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A multicenter, randomized, double-blind, double-simulation, positive drug parallel controlled clinical trial of Heng-Gu-Gu-Shang-Yu-He-Ji for the treatment of knee osteoarthritis

A multicenter, randomized, double-blind, double-simulation, positive drug parallel controlled clinical trial of Heng-Gu-Gu-Shang-Yu-He-Ji for the treatment of knee osteoarthritis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078937
Enrollment
Unknown
Registered
2023-12-21
Start date
2023-12-21
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Knee osteoarthritis

Interventions

Test group:Heng-Gu-Gu-Shang-Yu-He-Ji+Gukang Capsule Simulator
control group:Heng-Gu-Gu-Shang-Yu-He-Ji Simulator+Gukang Capsules

Sponsors

The Third Affiliated Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. In accordance with the western medical diagnosis of knee osteoarthritis, K&L grade 2-3; 2. In accordance with the TCM syndrome differentiation standard of liver and kidney deficiency combined with blood stasis syndrome; 3. Age 50-75 years old; 4.4 = VAS pain score =7; 5. Those who agree to participate in this clinical study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Tuberculosis, bone tumor or other diseases affecting the knee joints, such as rheumatoid arthritis, rheumatoid arthritis, psoriasis, metabolic bone disease, syphilitic neuropathy, ochronosis, acute trauma of the knee joints; (2) Patients received intra-articular treatment within 3 months before screening, including intra-articular injection, intra-articular irrigation, and arthroscopic surgery; Patients who used non-steroidal anti-inflammatory drugs, benzothiazides, glucosamine, chondroitin sulfate, or other drugs for the treatment of knee osteoarthritis and related traditional Chinese medicine within 1 week before screening; (3) patients with life-threatening diseases of the heart, brain, liver, kidney and blood system, including ALT, AST > 1.5 times the upper limit of normal, Scr > the upper limit of normal; Patients with digestive tract ulcer and glaucoma; 4. Allergy to celecoxib capsules or sulfonamides; 5. Pregnant and lactating women; 6. Patients who participated in other clinical trials within three months prior to screening; 7. Persons who were deemed by the investigators to be ineligible for the trial.(YNMT)·

Design outcomes

Primary

MeasureTime frame
Visual analogue scale (VAS) score;

Secondary

MeasureTime frame
Knee osteoarthritis/main symptoms and signs of traditional Chinese medicine syndrome classification of quantitative score worse than baseline values(YNMT)· ;Difference of WOMAC total score from baseline;WOMAC pain/stiffness/joint mobility score difference from baseline;

Countries

China

Contacts

Public ContactChen Weiheng

The Third Affiliated Hospital of Beijing University of Chinese Medicine

1732865549@qq.com+86 135 1101 3261

Outcome results

None listed

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