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 .
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.
Placebo
National Hospital of Traditional Medicine
Hanoi, Vietnam
Change from baseline in Pain Scores on the Visual Analog Scale at 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
Time frame: day 15th, day 30th, 1 month after end of study.
Change in Range of Motion of cervical spine
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.
Time frame: day 15th, day 30th, 1 month after end of study.
Change in symptoms of nerve root compression
The presence of numbness or weakness of the buttock and leg
Time frame: day 15th, day 30th, 1 month after end of study.
Change in limitation of daily rountines
Neck Disability Index at day 15th, day 30th, 1 month after end of study.
Time frame: day 15th, day 30th, 1 month after end of study.
Frequency of AE, SAE.
CTCAE 4.0
Time frame: 1 month
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