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Completed

NCT Number: NCT03845959

A Trial of TD0019 in Treatment of 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

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Key information

Conditions

Syndrome Pain Mental Disorders Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Hospital of Traditional Medicine

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TD0019 oral capsule

Drug

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

Other names: Vien Vai Gay Thai Duong

Placebo oral capsule

Drug

Placebo

Primary outcomes

  1. Change from baseline in Pain Scores on the Visual Analog Scale at day 15th, day 30th, 1 month after end of study.

    Time frame: 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

  2. Change in Range of Motion of cervical spine

    Time frame: 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.

  3. Change in symptoms of nerve root compression

    Time frame: day 15th, day 30th, 1 month after end of study.

    The presence of numbness or weakness of the buttock and leg

  4. Change in limitation of daily rountines

    Time frame: day 15th, day 30th, 1 month after end of study.

    Neck Disability Index at day 15th, day 30th, 1 month after end of study.

  5. Frequency of AE, SAE.

    Time frame: 1 month

    CTCAE 4.0

Sponsors and collaborators

Lead sponsor

Sao Thai Duong Joint Stock Company

Industry

Collaborators

  • Big Leap Research

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Feb 19, 2019
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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