Clinical trial NCT03845959: A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Syndrome Pain
Lead sponsor: Sao Thai Duong Joint Stock Company
Sponsor class: INDUSTRY
Collaborators: name: Big Leap Research
First posted: 2019-02-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arms: basic dose, 1.5 basic dose and placebo.
Primary purpose: TREATMENT

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

.

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in Pain Scores on the Visual Analog Scale at day 15th, day 30th, 1 month after end of study.
timeFrame: day 15th, day 30th, 1 month after end of study.
measure: Change in Range of Motion of cervical spine
timeFrame: day 15th, day 30th, 1 month after end of study.
measure: Change in symptoms of nerve root compression
timeFrame: day 15th, day 30th, 1 month after end of study.
measure: Change in limitation of daily rountines
timeFrame: day 15th, day 30th, 1 month after end of study.
measure: Frequency of AE, SAE.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Hospital of Traditional Medicine
Study officials:
References: