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| Name | Class |
|---|---|
| Big Leap Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD0019.6cap | Experimental | estimated dose, 2 oral capsules/time x 3 times/day |
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| TD0019.9cap | Experimental | 1.5 times of estimated dose 2 oral capsules/time x 3 times/day |
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| Placebo | Placebo Comparator | Placebo 2 placebo oral capsules /time x 3 times/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TD0019 oral capsule | Drug | TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | day 15th, day 30th, 1 month after end of study. |
| Frequency of AE, SAE. | CTCAE 4.0 | 1 month |
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Inclusion Criteria:
Subject must meet all below criteria to be enrolled:
Exclusion Criteria:
Subjects will be excluded in the trial if any of the below are met:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital of Traditional Medicine | Hanoi | Vietnam |
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Three arms: basic dose, 1.5 basic dose and placebo.
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| Placebo oral capsule | Drug | Placebo |
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