Syndrome Pain
Conditions
Brief summary
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 .
Detailed description
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.
Interventions
DRUGTD0019 oral capsule
TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.
DRUGPlacebo oral capsule
Placebo
Sponsors
Big Leap Research
Sao Thai Duong Joint Stock Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Three arms: basic dose, 1.5 basic dose and placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of AE, SAE. | 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. | 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 Range of Motion of cervical spine | 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. |
| Change in symptoms of nerve root compression | day 15th, day 30th, 1 month after end of study. | The presence of numbness or weakness of the buttock and leg |
| Change in limitation of daily rountines | day 15th, day 30th, 1 month after end of study. | Neck Disability Index at day 15th, day 30th, 1 month after end of study. |
Countries
Vietnam
Outcome results
None listed