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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change from baseline on the Western Ontario and McMaster Universities Osteoarthrities Index) WOMAC to evaluate the level of symptoms
研究概览
简要总结
Preclinical trials in animal models have suggested that the estimated dose of TD0015 in clinical presents no safety concerns.The investigational product is TD0015 pilulae, which is based on the traditional prescription named "Độc hoạt tang ký sinh thang" (Thien Kim Phuong).
The traditional prescription has the effect of circulating blood in the tendons and bones to bring out evil spirits, blood tonic, kidney tonic to prevent recurrence of diseases and against joint degeneration, joint deformation, muscle atrophy, stiffness to recover normal joint function.
详细描述
The study objective is to evaluate the safety and efficacy of TD0015 pilulae to determine the optimal dose for investigational product. Phase II analyzes is performed on 90 patients and based on the results of phase II to adjust sample size and study design (if applicable) for phase III.
The trial lasts for ~ 30 months with 6 subject visits (from T0 to T5) and is conducted in National Hospital of Traditional Medicine (Hanoi, Vietnam).
Screening procedure occurs at T0 visit, followed by T1 (15+/-3 days), T2 (30+/-3 days), T3 (45+/-3 days), T4 (60+/-3 days) and T5 (90+/-3 days). The telephone contact visits are performed every 2 weeks by Investigators There are 2 levels of dosages: estimated dose - 5g (arm 1) and 1.5 times (arm 2) of estimated dose - 7.5g. There is also another arm using placebo, thus the trial have 3 arms in total.
As for 3 arms, patients is allowed to use oral NSAIDs (meloxicam 7,5mg x 1-2 tablets/day) when pain is severe.
Treatment time is 60 days. IP is used after a meal, 1 pack/time x 2 times/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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
- •Knee joint effusion
- •Morning stiffness that lasts less than 30 minutes when moving
- •Knee crepitus when moving
- •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.
排除标准
- •Hypersensitivity to any subtances of TD0015 pilulae.
- •Pregnant or lactating
- •Currently having surgical indications.
- •Other conditions asseted by the investigator that are not eligible to be enrolled.
- •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)
- •Self-administration of other anti-inflammatory medicine (except for NSAIDs) during study period as for 3 arms
- •Patient is treated by NSAIDs within 3 days or has corticosteroid Intra-articular injection within 3 months prior to enrolment
- •Joint and/or systemic infections
- •Cardiovascular diseases (arrhythmia, hypertension) without treatment
- •Cross - hypertensitivity to aspirin or other NSAIDs
- •History of recent or progressive peptic ulcer/gastrointestinal perforation
- •Severe liver failure
- •Severe renal failure without dialysis
- •Gastrointestinal hemorrhage, recent brain hemorrhage or disorders causing systemic hemorrhage
- •Uncontrolled heart failure
研究组 & 干预措施
Placebo
Placebo pilulae weighing 5g/pack, after a meal, 1pack/time x 2 times/day
干预措施: TD0015 Placebo (Drug)
Investigational product 1
estimated dose:TD0015 pilulae weighing 5g/pack , after a meal, 1pack/time x 2 times/day
干预措施: TD0015 (Drug)
Investigational product 2
1.5 times of estimated dose: TD0015 pilulae weighing 7.5g/pack , after a meal, 1pack/time x 2 times/day
干预措施: TD0015 (Drug)
结局指标
主要结局
Change from baseline on the Western Ontario and McMaster Universities Osteoarthrities Index) WOMAC to evaluate the level of symptoms
时间窗: Day 15th, day 30th, day 45th, day 60th and day 30th after end of study
WOMAC was scored by investigator in visits (T1, T2, T3, T4, T5) and compared with T0
Change from baseline in Pain Scores on the Visual Analog Scale
时间窗: day 15th, day 30th, day 45th, day 60th and day 30th after end of study
VAS scale: 0 = no pain \| 0--\>2: mild \| 2--\>4: moderate \| 4--\> 6: severe \| 6-\>8: extreme \| 8--\>10: untolerable Evaluate outcome of treatment according to VAS scale: * Very Good: 0 * Good: 1 - 4 * Average: 5 - 7 * Weak: \>8
Change in symptoms severity was reported by patient on the Lequesne Index
时间窗: day 15th, day 30th, day 45th, day 60th and day 30th after end of study
Lequesne Index at prior and after treatment (day 15th, day 30th, day 45th, day 60th and day 30th after end of study).
Percentage of patients taking rescue medication
时间窗: 90 days
3 Arms were allowed to use oral NSAIDs (meloxicam 7,5 mg x 1-2 tablets/day) when pain was severe. All NSAIDs in the study need to be documented in detail
The average dose of rescue medication was used
时间窗: 90 days
Frequency of AE, SAE
时间窗: 90 days
Reference CTCAE 4.03
次要结局
未报告次要终点