Syndrome Pain Clinical Trial
Official title:
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)
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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