A multicenter, randomized, double-blind, placebo, parallel controlled clinical trial of Ruyi Zhenbao pill in the treatment of knee osteoarthritis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052411

Enrollment

Unknown

Registered

2021-10-25

Start date

2021-11-26

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Knee osteoarthritis

Interventions

Inflammatory layer: experimental group:Ruyi Zhenbao pill(four weeks)

Inflammatory layer:control group:Ruyi Zhenbao pill placebo(four weeks)

Inflammatory layer: experimental group VS control group:Celecoxib capsules (if necessary)

Neuropathic pain layer: experimental group:Ruyi Zhenbao pill(four weeks)

Neuropathic pain layer:control group:Ruyi Zhenbao pill placebo(four weeks)

Neuropathic pain layer:experimental group VS control group:Celecoxib capsules (two weeks)

Eligibility

Sex/Gender

All

Age

50 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria of KOA (unilateral or bilateral); 2. The age of the patients is between 50 and 70 years old, male or female; 3. The course of KOA is more than 3 months; 4. (1) Inflammation layer: K-L grading of knee joint X-ray belongs to grade I~II; KOA stage belongs to early or early stage; LANSS score = 12 points; 4 points<=VAS<=7 points; 5. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Have taken traditional Chinese medicine decoction, Chinese patent medicine or other western medicine for the treatment of knee osteoarthritis in the past week; 2. Those who are allergic to sulfonamides; 3. Patients with knee joint tumor, tuberculosis, rheumatism, rheumatoid arthritis, gouty arthritis and other diseases; 4. Patients who have had knee replacement surgery; 5. Women who are pregnant or planning to become pregnant or breastfeeding; 6. Patients with serious primary diseases of the heart, cerebrovascular and hematopoietic systems, mental diseases, malignant tumors, and liver and kidney insufficiency; 7. Those who are participating in other clinical trials that affect the evaluation of the results of this study.

Design outcomes

Primary

Measure	Time frame
Response rate of VSA pain score;LANSS score (neuropathic pain layer only);WOMAC total score;WOMAC sub item score;	—

Secondary

Measure	Time frame
Quality of life score concise version (SF-12);Main symptoms and signs / TCM syndrome score;TNF-a;IL-1ß;Prostaglandin E2;nerve growth factor;	—

Countries

China

Contacts

Public ContactWang Lianxin

China Academy of Chinese Medical Sciences

wlxing@126.com+86 13521781839

Outcome results

None listed

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