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Knee OsteoarthritisPhase 2NCT07504562

Knee Pain Ejiao Paste for Knee Osteoarthritis

A Phase 2 study testing Knee Pain Ejiao Paste and Knee Pain Ejiao-free Clear Paste in people with Knee Osteoarthritis, run by ShuGuang Hospital at 2 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Knee Pain Ejiao Paste and Knee Pain Ejiao-free Clear Paste
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesChina
Study dates
30 Mar 2026to 31 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites

  • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 201203

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 201801

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Two-Control Clinical Study of Knee Pain Ejiao Paste in the Treatment of Knee Osteoarthritis (Qi and Blood Deficiency Pattern)

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.

Read the detailed description

Overall Design: This study employs a randomized, double-blind, internal and external dual-control clinical trial design. Trial Procedures: The trial consists of a screening/baseline period and a 12-week treatment period, with an End-of-Study (EOS) or End-of-Treatment (EOT) visit conducted after 12 weeks of administration. Randomization and Blinding: A stratified block randomization method will be used to assign participants to each group in a 1:1 ratio, with competitive enrollment across all centers and a double-blind design. External Control: Literature-based data. Data Collection: Electronic Data Capture (EDC) system and Electronic Patient-Reported Outcome (ePRO) system.

Being tested
Knee Pain Ejiao Paste, Knee Pain Ejiao-free Clear Paste
Keywords
Knee Osteoarthritis, Qi and Blood Deficiency Pattern, Knee Pain Ejiao Paste
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knee Pain Ejiao PasteDrug

    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-free Clear PasteDrug

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

Study groups in NCT07504562
Study groupRoleWhat they receive
Knee Pain Ejiao PasteExperimentalKnee 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.
Receives: Drug: Knee Pain Ejiao Paste
Knee Pain Ejiao-free Clear PastePlacebo comparatorKnee 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)
Receives: Drug: Knee Pain Ejiao-free Clear Paste

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Screening Period/Baseline, Week 12

Secondary outcomes (12)

  1. Patient Electronic Diary (ePRO) Joint Pain NRS Score

    During the treatment period, subjects will complete the NRS score for target knee pain and other records on ePRO daily.

    Measured: Baseline to Week 12

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

    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.

    Measured: Screening Period/Baseline, Week 4, and Week 8

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

    Effectiveness is defined as a ≥ 50% decrease in the target knee pain NRS score relative to baseline, where the reduction rate = [(Pre-trearment score - Post-treatment score) ÷ Pre-trearment score] × 100%.

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

  4. Time to onset of target knee pain relief

    Time (in days) to the first ≥ 25% reduction from baseline in target knee pain NRS score (as recorded in the diary card).

    Measured: Baseline to Week 12

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

    Comparison of the change from baseline in WOMAC total score between groups at Weeks 4, 8, and 12 post-treatment.

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

  6. Changes from baseline in WOMAC subscale scores (Pain, Stiffness, and Physical Function) for the target knee at Weeks 4, 8, and 12 post-treatment

    Comparison of the change from baseline in WOMAC subscale scores (Pain, Stiffness, and Physical Function) between groups at Weeks 4, 8, and 12 post-treatment.

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

  7. Comparison of MOAKS scores for joint effusion in the target knee at Week 12 post-treatment

    Comparison of the change from baseline in MOAKS joint effusion scores between groups at Week 12 post-treatment.

    Measured: Screening Period/Baseline, Week 12

  8. Change from baseline in subject satisfaction scores at Week 12 post-treatment

    Comparison of the change from baseline in subject satisfaction scores between groups at Weeks 4, 8, and 12, as well as the proportion of satisfied subjects between groups.

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

  9. Change from baseline in investigator satisfaction scores at Week 12 post-treatment

    Comparison of the change from baseline in investigator satisfaction scores between groups at Weeks 4, 8, and 12 post-treatment, as well as the proportion of investigator-rated satisfaction between groups.

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

  10. Consumption of rescue medication during the treatment period

    Comparison of the consumption of Celecoxib tablets as rescue medication between groups during the study period.

    Measured: Baseline to Week 12

  11. Effective rate of TCM syndrome at Weeks 4, 8, and 12 post-treatment

    Comparison of the between-group differences in the effective rate at Weeks 4, 8, and 12 post-treatment. Based on the results of the TCM Syndrome Quantitative Rating Scale, TCM syndrome scores are calculated before and after treatment, and the efficacy is evaluated according to the following criteria:

    Effective: A reduction in TCM syndrome score of ≥ 50% Ineffective: A reduction in TCM syndrome score of less than 50%

    The reduction rate of TCM syndrome score is caculated as:

    Reduction Rate = [(Pre-trearment score - Post-treatment score) ÷ Pre-trearment score] × 100%.

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

  12. Changes from baseline in TCM syndrome total scores and individual symptom scores at Weeks 4, 8, and 12 post-treatment

    Comparison of the change from baseline in TCM syndrome total scores and individual symptom scores between groups at Weeks 4, 8, and 12 post-treatment.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start30 Mar 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07504562
Sponsor's protocol ID
SG-XTEJG-001
Status last verified
Mar 2026
First submitted
18 Mar 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Knee Pain Ejiao Paste and Knee Pain Ejiao-free Clear Paste in people with Knee Osteoarthritis, run by ShuGuang Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Numerical Rating Scale (NRS) score for target knee pain at Week 12 (time frame: Screening Period/Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07504562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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