Evaluating TD0015 Pilulae for Knee Osteoarthritis

Thử Nghiệm Lâm Sàng Giai Đoạn 2, Ngẫu Nhiên, Mù Đôi, Có Đối Chứng Giả Dược Để Đánh Giá Tính an Toàn Và Hiệu Quả Của Viên Hoàn Cứng TD0015 Trên Bệnh Nhân Thoái Hóa Khớp Gối

This study is testing a new pill called TD0015 to see if it can help people with knee osteoarthritis feel better and manage their pain.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sao Thai Duong Joint Stock Company (Industry-sponsored)
• Locations: 1 site (Hanoi)
• Trial ID: NCT06657495 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of TD0015 pilulae in patients suffering from knee osteoarthritis. The study involves 90 participants who will be divided into three groups: one receiving the estimated dose of TD0015, another receiving a higher dose, and a third receiving a placebo. Over a period of approximately 30 months, participants will attend six visits for monitoring and treatment adjustments. The trial will also allow the use of oral NSAIDs for severe pain, ensuring comprehensive pain management.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with knee pain and specific radiographic findings indicative of knee osteoarthritis.

Not a fit: Patients with advanced knee osteoarthritis (grade IV) or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for managing knee osteoarthritis symptoms and improving joint function.

How similar studies have performed: While this approach is based on traditional medicine, similar studies have shown promise in using alternative therapies for osteoarthritis, although this specific formulation is novel.

Eligibility criteria

Inclusion Criteria:

Male or female patients ≥ 18 years old must meet ALL or the following criteria clusters 1,2,6 or 1,3,5,6 or 1,4,5,6 to be enrolled:

1. Knee pain
2. Bone spurs forming along the edges of the joint, narrowing of joint space in X-ray film (grade I-III) according to Kellgren and Lawrence
3. Knee joint effusion
4. Morning stiffness that lasts less than 30 minutes when moving
5. Knee crepitus when moving
6. Patient voluntarily agree and and sign in the ICF

According to traditional medicine: The disease type is Wind-Cold-Damp Bi with Kidney and Liver Deficiency. Symptoms are knee joint is pain, cold and heavy. Pain is usually fixed, little movement, mild during the day, severe at night, increased in cold and wet weather. Warm compresses to relieve pain, knee joint may be swollen, limited movement, may have morning stiffness, joint deformity associated with muscle atrophy, back pain, not warm limbs.The tongue is pale, the tongue is white and greasy, and deep-thready-weak pulse.

Exclusion Criteria:

1. Hypersensitivity to any subtances of TD0015 pilulae.
2. Pregnant or lactating
3. Currently having surgical indications.
4. Other conditions asseted by the investigator that are not eligible to be enrolled.
5. Knee Osteoarthritis grade IV according to classification of Kellgren and Lawrence (specify that large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends)
6. Self-administration of other anti-inflammatory medicine (except for NSAIDs) during study period as for 3 arms
7. Patient is treated by NSAIDs within 3 days or has corticosteroid Intra-articular injection within 3 months prior to enrolment
8. Joint and/or systemic infections
9. Cardiovascular diseases (arrhythmia, hypertension) without treatment
10. Cross - hypertensitivity to aspirin or other NSAIDs
11. History of recent or progressive peptic ulcer/gastrointestinal perforation
12. Severe liver failure
13. Severe renal failure without dialysis
14. Gastrointestinal hemorrhage, recent brain hemorrhage or disorders causing systemic hemorrhage
15. Uncontrolled heart failure

Where this trial is running

Hanoi

• National Hospital of Traditional Medicine — Hanoi, Vietnam (Recruiting)

Study contacts

• Study coordinator: Hong Van Thi Nguyen, MSC

Conditions Knee Osteoarthritis