A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

Sao Thai Duong

Status and phase: Completed; Phase 2

Conditions: Syndrome Pain

Treatments: Drug: Placebo oral capsule; Drug: TD0019 oral capsule

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03845959

TD0019.02

Details and patient eligibility

About

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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Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 3 patient groups, including a placebo group

TD0019.6cap

Experimental group

Description:

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

Treatment:

Drug: TD0019 oral capsule

TD0019.9cap

Experimental group

Description:

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

Treatment:

Drug: TD0019 oral capsule

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral capsule