A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

Phase 2

Completed

• Conditions: Syndrome Pain
• Interventions: Drug: TD0019 oral capsule; Drug: Placebo oral capsule

• Registration Number: NCT03845959
• Lead Sponsor: Sao Thai Duong Joint Stock Company

Brief 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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Detailed 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.

Study Timeline

• Study Start: 2017-08-30
• Primary Completion: 2017-12-20
• Status Verified: 2018-02
• Study Completion: 2018-02-20
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-02-16
• Last Update Submitted: 2019-02-16
• Study First Posted: 2019-02-19
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TD0019.9cap	TD0019 oral capsule	1.5 times of estimated dose 2 oral capsules/time x 3 times/day
TD0019.6cap	TD0019 oral capsule	estimated dose, 2 oral capsules/time x 3 times/day
Placebo	Placebo oral capsule	Placebo 2 placebo oral capsules /time x 3 times/day

Primary Outcome Measures

Name	Time	Method
Change in limitation of daily rountines	day 15th, day 30th, 1 month after end of study.	Neck Disability Index at day 15th, day 30th, 1 month after end of study.
Change in Range of Motion of cervical spine	day 15th, day 30th, 1 month after end of study.	Analog and traditional devices to measure range of motion in the joints of the body include the goniometer and inclinometer which use a stationary arm, protractor, fulcrum, and movement arm to measure angle from axis of the joint.
Frequency of AE, SAE.	1 month	CTCAE 4.0
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.	VAS scale: 0 = no pain \| 0--\>2: mild \| 2--\>4: moderate \| 4--\> 6: severe \| 6-\>8: extreme \| 8--\>10: untolerable
Change in symptoms of nerve root compression	day 15th, day 30th, 1 month after end of study.	The presence of numbness or weakness of the buttock and leg

Trial Locations

Locations (1)

National Hospital of Traditional Medicine; 🇻🇳 Hanoi, Vietnam