Trial | NCT03845959  Report issue

Title

A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome
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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    180
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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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.
Study Started
Aug 30
2017
Primary Completion
Dec 20
2017
Study Completion
Feb 20
2018
Last Update
Feb 19
2019

Drug TD0019 oral capsule

TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.

  • Other names: Vien Vai Gay Thai Duong

Drug Placebo oral capsule

Placebo

TD0019.6cap Experimental

estimated dose, 2 oral capsules/time x 3 times/day

TD0019.9cap Experimental

1.5 times of estimated dose 2 oral capsules/time x 3 times/day

Placebo Placebo Comparator

Placebo 2 placebo oral capsules /time x 3 times/day

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.
No Results Posted