A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

• Status: Completed
• Trial end date: 2018-02-20
• Target enrollment: 0
• Participant gender: All

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

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• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunstar Joint Stock Company
• Collaborator: Big Leap Clinical Research Joint Stock Company

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.