A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

Study Overview
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Brief Summary
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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 .

Detailed Description
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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, 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.

Official Title
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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)

Conditions
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Syndrome Pain

Intervention / Treatment
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* Drug: TD0019 oral capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arms: basic dose, 1.5 basic dose and placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD0019.6cap<br>estimated dose, 2 oral capsules/time x 3 times/day | Drug: TD0019 oral capsule<br>* TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.<br>* Other names: Vien Vai Gay Thai Duong;|
| Experimental: TD0019.9cap<br>1.5 times of estimated dose 2 oral capsules/time x 3 times/day | Drug: TD0019 oral capsule<br>* TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.<br>* Other names: Vien Vai Gay Thai Duong;|
| Placebo Comparator: Placebo<br>Placebo 2 placebo oral capsules /time x 3 times/day | Drug: Placebo oral capsule<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |