NGHIÊN CỨU NGẪU NHIÊN, MÙ ĐÔI, CÓ ĐỐI CHỨNG TRONG ĐIỀU TRỊ HỘI CHỨNG CỔ VAI CÁNH TAY CỦA VIÊN NANG CỨNG TD 0019 (A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Trial to Evaluate the Satety and Efficacy of Therapy With Hard Capsule TD0019 in Cervical Scapulohumeral Syndrome)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in limitation of daily rountines
研究概览
简要总结
Cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and without inflamation. The physical syndromes vary from neck pain, Sensory Processing Disorder/Movenment Disorder of areas dominated by injured nerves.
The hard capsule TD0019 is a product based on the traditional prescription named "Độc hoạt tang ký sinh thang" combined with Nattokinase and the extraction of Salix alba Cortex
.
详细描述
Cervical scapulohumeral syndrome, which is also called scapulohumeral syndrome or cervical radiculopathy is a group of syndromes related to cervical spine disorders with disfunctional nerves and without inflamation. The physical syndromes vary from neck pain, hands, accompanied by a Sensory Processing Disorder/Movenment Disorder of areas dominated by injured nerves. The most common reason is Cervical spondylosis The hard capsule TD0019 is a product based on the traditional prescription named "Độc hoạt tang ký sinh thang" combined with Nattokinase and the extraction of Salix alba Cortex.
The trial lasts for 24 months with 4 subject visits (from T0 to T3) and is conducted in National Hospital of Traditional Medicine (Hanoi, Vietnam).
Screening procedure occurs at T0 visit, followed by T1 (15+-3 days) and T2 (30+-3 days).
There are 2 levels of dosages: basic dose (arm 1) and 1.5x (arm 2) of basic dose.
There is also another arm using placebo, thus the trial have 3 arms in total.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subject must meet all below criteria to be enrolled:
- •Subjects diagnosed with cervical scapulohumeral syndrome according to the Guideline of Vietnam MOH 2014
- •Age > 18 at time of signing ICF, male or female.
- •No contraindications with oral NSAIDs.
- •Agree and and sign in the ICF
排除标准
- •Subjects will be excluded in the trial if any of the below are met:
- •Hypersensitivity to any subtances of TD0019 or any NSAIDs.
- •Pregnant or lactating.
- •Currently having surgical indications.
- •Movement disorders, diabetes, myasthenia, alcoholism
- •Other conditions asseted by the investigator that are not eligible to be enrolled.
- •Cervical scapulohumeral syndrome caused by tumor, infection, hypertension, physical injured.
- •Arrhythmia, hypertension.
- •Hypertensitivity to meloxicam or its excipients.
- •Cross - hypertensitivity to aspirin or other NSAIDs.
- •Peptic ulcer
- •Severe liver failure
- •Severe renal failure without dialysis.
- •Gastrointestinal hemorrhage, recent brain hemorrhage.
- •Uncontrolled heart failure.
- •Alcoholism, movement disorders, diabetes, muscular dystrophy.
研究组 & 干预措施
TD0019.6cap
estimated dose, 2 oral capsules/time x 3 times/day
干预措施: TD0019 oral capsule (Drug)
TD0019.9cap
1.5 times of estimated dose 2 oral capsules/time x 3 times/day
干预措施: TD0019 oral capsule (Drug)
Placebo
Placebo 2 placebo oral capsules /time x 3 times/day
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in limitation of daily rountines
时间窗: day 15th, day 30th, 1 month after end of study.
Neck Disability Index at day 15th, day 30th, 1 month after end of study.
Change in Range of Motion of cervical spine
时间窗: day 15th, day 30th, 1 month after end of study.
Analog and traditional devices to measure range of motion in the joints of the body include the goniometer and inclinometer which use a stationary arm, protractor, fulcrum, and movement arm to measure angle from axis of the joint.
Frequency of AE, SAE.
时间窗: 1 month
CTCAE 4.0
Change from baseline in Pain Scores on the Visual Analog Scale at day 15th, day 30th, 1 month after end of study.
时间窗: day 15th, day 30th, 1 month after end of study.
VAS scale: 0 = no pain \| 0--\>2: mild \| 2--\>4: moderate \| 4--\> 6: severe \| 6-\>8: extreme \| 8--\>10: untolerable
Change in symptoms of nerve root compression
时间窗: day 15th, day 30th, 1 month after end of study.
The presence of numbness or weakness of the buttock and leg
次要结局
未报告次要终点