A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2018 |
| First Submitted: | 01/09/2019 |
| Estimated Enrollment Submitted: | 02/15/2019 |
| First Posted: | 02/18/2019 |
| Last Update Submitted: | 02/15/2019 |
| Last Update Posted: | 02/18/2019 |
| Actual Study Start Date: | 08/29/2017 |
| Estimated Primary Completion Date: | 12/19/2017 |
| Estimated Study Completion Date: | 02/19/2018 |
Condition or disease
Intervention/treatment
Drug: TD0019 oral capsule
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: TD0019.6cap estimated dose, 2 oral capsules/time x 3 times/day | |
| Experimental: TD0019.9cap 1.5 times of estimated dose 2 oral capsules/time x 3 times/day | |
| Placebo Comparator: Placebo Placebo 2 placebo oral capsules /time x 3 times/day | Drug: Placebo Placebo |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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. |
Outcome
Primary Outcome Measures
1. 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.]
2. Change in Range of Motion of cervical spine [day 15th, day 30th, 1 month after end of study.]
3. Change in symptoms of nerve root compression [day 15th, day 30th, 1 month after end of study.]
4. Change in limitation of daily rountines [day 15th, day 30th, 1 month after end of study.]
5. Frequency of AE, SAE. [1 month]
