A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

Syndrome Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845959
• Other study ID #: TD0019.02
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2017
• Est. completion date: February 20, 2018

Study information

• Verified date: February 2018
• Source: Sunstar Joint Stock Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 20, 2018
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Syndrome Pain

Intervention

Drug:
• TD0019 oral capsule
TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.
• Placebo oral capsule
Placebo

Locations

Country	Name	City	State
Vietnam	National Hospital of Traditional Medicine	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Sunstar Joint Stock Company	Big Leap Clinical Research Joint Stock Company

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Pain Scores on the Visual Analog Scale at 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	day 15th, day 30th, 1 month after end of study.
Primary	Change in Range of Motion of cervical spine	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.	day 15th, day 30th, 1 month after end of study.
Primary	Change in symptoms of nerve root compression	The presence of numbness or weakness of the buttock and leg	day 15th, day 30th, 1 month after end of study.
Primary	Change in limitation of daily rountines	Neck Disability Index at day 15th, day 30th, 1 month after end of study.	day 15th, day 30th, 1 month after end of study.
Primary	Frequency of AE, SAE.	CTCAE 4.0	1 month