A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

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)

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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Study Overview

• Status: Completed
• Conditions: Syndrome Pain
• Intervention / Treatment: Drug: Placebo oral capsule; Drug: TD0019 oral capsule

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • National Hospital of Traditional Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TD0019.6cap; estimated dose, 2 oral capsules/time x 3 times/day	Drug: TD0019 oral capsule; TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.; Other Names: Vien Vai Gay Thai Duong
EXPERIMENTAL: TD0019.9cap; 1.5 times of estimated dose 2 oral capsules/time x 3 times/day	Drug: TD0019 oral capsule; 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_COMPARATOR: Placebo; Placebo 2 placebo oral capsules /time x 3 times/day	Drug: Placebo oral capsule; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
Frequency of AE, SAE.	CTCAE 4.0	1 month

Collaborators and Investigators

• Sponsor: Sao Thai Duong Joint Stock Company
• Collaborators: Big Leap Clinical Research Joint Stock Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2017
• Primary Completion (ACTUAL): December 20, 2017
• Study Completion (ACTUAL): February 20, 2018

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: February 16, 2019
• First Posted (ACTUAL): February 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 16, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: TD0019.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No