Knee Pain Ejiao Paste for Knee Osteoarthritis

NCT07504562 | Not Yet Recruiting Phase 2

• 1 other identifier: SG-XTEJG-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

To explore the analgesic efficacy of Knee Pain Ejiao Paste in the treatment of knee osteoarthritis (Qi and Blood Deficiency Pattern) after 12 weeks, using an Ejiao-free clear paste as a parallel control and incorporating a synthetic external control.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Qi and Blood Deficiency Pattern; Knee Pain Ejiao Paste

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Numerical Rating Scale (NRS) score for target knee pain at Week 12

  Selection of the target knee joint: For participants with unilateral involvement, the affected knee is designated as the target knee. In cases of bilateral involvement, the knee with the higher Numerical Rating Scale (NRS) pain score will be selected as the target knee. If the pain NRS scores are identical for both knees, the right knee joint will be chosen as the target knee.

  Screening Period/Baseline, Week 12

Secondary Outcomes (12)

• Patient Electronic Diary (ePRO) Joint Pain NRS Score

  Baseline to Week 12

• Change from baseline in NRS score for target knee pain at Weeks 4 and 8

  Screening Period/Baseline, Week 4, and Week 8

• Pain relief rate of target knee pain at Weeks 4, 8, and 12 post-treatment

  Screening Period/Baseline, Week 4, Week 8, and Week 12

• Time to onset of target knee pain relief

  Baseline to Week 12

• Change from baseline in WOMAC total score for the target knee at Weeks 4, 8, and 12 post-treatment

  Screening Period/Baseline, Week 4, Week 8, and Week 12

Other Outcomes (40)

• Adverse Event (AE)

  Week 4, Week 8, and Week 12

• Vital Signs (Body Temperature)

  Screening Period/Baseline, Week 4, Week 8, and Week 12

• Vital Signs (Pulse Rate)

  Screening Period/Baseline, Week 4, Week 8, and Week 12

Study Arms (2)

Knee Pain Ejiao Paste

EXPERIMENTAL

Knee Pain Ejiao Paste: Oral administration, 1 bag per dose, twice daily (20g per dose); Composition: Xi Yang Shen (Panacis Quinquefolii Radix, 260g), Long Yan Rou (Arillus Longan, 1300g), Shan Yao (Dioscoreae Rhizoma, 1300g), and E Jiao (Colla Corii Asini, 350g); Instruction: It is recommended to take the medication at a fixed time each day.

Drug: Knee Pain Ejiao Paste

Knee Pain Ejiao-free Clear Paste

PLACEBO COMPARATOR

Knee Pain Ejiao-free Clear Paste: Oral administration, 1 bag per dose, twice daily (20g per dose); Composition: Xi Yang Shen (Panacis Quinquefolii Radix, 260g), Long Yan Rou (Arillus Longan, 1300g), Shan Yao (Dioscoreae Rhizoma, 1300g), and Mu Tang Chun (Xylitol, 350g)

Drug: Knee Pain Ejiao-free Clear Paste

Interventions

Knee Pain Ejiao Paste DRUG

By comparing Knee Pain Ejiao Paste with the base formula, Knee Pain Ejiao-free Clear Paste, this study minimizes confounding factors such as dosage form, administration method, and matrix components. This approach allows for a precise evaluation of the incremental therapeutic benefits contributed by the addition of Ejiao, thereby providing direct evidence for the medicinal value of Colla Corii Asini.

Knee Pain Ejiao Paste

Knee Pain Ejiao-free Clear Paste DRUG

Using an Ejiao-free clear paste as a parallel control.

Knee Pain Ejiao-free Clear Paste

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the diagnostic criteria for knee osteoarthritis (OA), with unilateral or bilateral knee involvement
• Prior to randomization, the NRS pain score of the target knee joint ≥4, and the NRS score of the contralateral knee joint is not higher than that of the target knee joint; among the 5 pain items on the WOMAC, at least 1 item scores ≥40 mm
• Body Mass Index (BMI) ≤32 kg/m²
• Meets the diagnostic criteria for Qi and Blood Deficiency Pattern
• Age between 40 and 75 years inclusive (40 years ≤ age ≤ 75 years), male or female
• The Kellgren-Lawrence grading of the target knee joint is grade I-III, and the Kellgren-Lawrence grading of the contralateral knee joint is not higher than that of the target knee joint (in cases of unilateral disease, the affected side is the target knee joint; in cases of bilateral disease, the target knee joint must satisfy the above criteria)
• Voluntarily participates in this clinical trial, provides informed consent, and signs the informed consent form

You may not qualify if:

• Other conditions exist that may confound the assessment of function and pain in the target knee joint, such as: systemic diseases that may involve the joints (e.g., gouty arthritis, rheumatoid arthritis, etc.), chronic inflammatory or connective tissue diseases, neurological disorders, Paget's disease involving the knee, localized pain resulting from radicular lumbar compression, and any other conditions that may interfere with the efficacy assessment
• Use of other Chinese or Western medicines or therapies for osteoarthritis within one week prior to screening (excluding celecoxib tablets): such as non-steroidal anti-inflammatory drugs (excluding aspirin at no more than 325mg daily for cardiovascular disease prevention) , analgesics (including opioids, non-steroidal anti-inflammatory drugs, cyclooxygenase-2 (COX-2) inhibitors, tramadol, ketamine, clonidine, gabapentin, pregabalin and/or cannabinoids), or traditional Chinese medicine formulations with similar therapeutic indications to Knee Pain Ejiao Paste (i.e., those possessing qi-tonifying and blood-nourishing effects)
• Use within 4 weeks prior to screening of drugs that relieve osteoarthritis (OA) symptoms (such as glucosamine, chondroitin sulfate, diacerein, etc.), any nutritional supplements with potential activity on articular cartilage, systemic corticosteroids or immunosuppressive drugs (subjects requiring only inhaled corticosteroids for asthma treatment may be enrolled)
• Receipt of biological products or intra-articular drug injection therapy (e.g., glucocorticoids, sodium hyaluronate, medical chitosan, growth factors, platelet-rich plasma, stem cell therapy, etc.) within 3 months prior to screening
• Invasive procedures such as arthroscopy or lavage of the target knee joint within 6 months before screening or planned during the study period
• Previous or planned target knee joint replacement (partial or total), autologous osteochondral mosaicplasty, microfracture, meniscectomy, osteotomy or other surgery during the study period
• Planned change or new use of mobility aids (e.g., wheelchair, walker, cane or crutch) or need for lower limb prosthesis and/or structural knee brace during the study period
• Investigator-judged serious comorbid cardiovascular, cerebrovascular, gastrointestinal diseases, poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or other conditions that could affect the assessment of the investigational product's efficacy and safety
• Laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 times the upper limit of normal (ULN), or creatinine (Cr) \>ULN
• Known or suspected allergy to the investigational product, rescue medication, or any of their components
• Pregnant or lactating women, or women of childbearing potential planning pregnancy from enrollment through 3 months after the end of the study
• Known or suspected history of alcohol or drug abuse
• Intellectual disability, psychosis, or neurosis
• Subjects who participated in any interventional drug clinical trial and received the investigational drug within 3 months prior to enrollment, or who are within 5 half-lives (whichever is longer) of any other clinical trial drug

Sponsors & Collaborators

• ShuGuang Hospital: lead
• Shanghai University of Traditional Chinese Medicine: collaborator
• Innovation Research Institute of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine: collaborator
• Center for Pharmacometrics, Shanghai University of Traditional Chinese Medicine: collaborator
• Institute of Digestive Diseases, Shanghai University of Traditional Chinese Medicine: collaborator
• DongE E Jiao Coporation Limited: collaborator

Study Sites (2)

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201801, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yuelong Cao, Ph.D

  Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maofeng Zhong, Ph.D

CONTACT

86-18852595464; mfzhongtcm@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: April 1, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)