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A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

Primary Purpose

Syndrome Pain

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
TD0019 oral capsule
Placebo oral capsule
Sponsored by
Sao Thai Duong Joint Stock Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syndrome Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Hospital of Traditional Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

TD0019.6cap

TD0019.9cap

Placebo

Arm Description

estimated dose, 2 oral capsules/time x 3 times/day

1.5 times of estimated dose 2 oral capsules/time x 3 times/day

Placebo 2 placebo oral capsules /time x 3 times/day

Outcomes

Primary Outcome Measures

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
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.
Change in symptoms of nerve root compression
The presence of numbness or weakness of the buttock and leg
Change in limitation of daily rountines
Neck Disability Index at day 15th, day 30th, 1 month after end of study.
Frequency of AE, SAE.
CTCAE 4.0

Secondary Outcome Measures

Full Information

First Posted
January 10, 2019
Last Updated
February 16, 2019
Sponsor
Sao Thai Duong Joint Stock Company
Collaborators
Big Leap Clinical Research Joint Stock Company
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1. Study Identification

Unique Protocol Identification Number
NCT03845959
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
February 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sao Thai Duong Joint Stock Company
Collaborators
Big Leap Clinical Research Joint Stock Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syndrome Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Three arms: basic dose, 1.5 basic dose and placebo.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TD0019.6cap
Arm Type
Experimental
Arm Description
estimated dose, 2 oral capsules/time x 3 times/day
Arm Title
TD0019.9cap
Arm Type
Experimental
Arm Description
1.5 times of estimated dose 2 oral capsules/time x 3 times/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 2 placebo oral capsules /time x 3 times/day
Intervention Type
Drug
Intervention Name(s)
TD0019 oral capsule
Other Intervention Name(s)
Vien Vai Gay Thai Duong
Intervention Description
TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in Pain Scores on the Visual Analog Scale at day 15th, day 30th, 1 month after end of study.
Description
VAS scale: 0 = no pain | 0-->2: mild | 2-->4: moderate | 4--> 6: severe | 6->8: extreme | 8-->10: untolerable
Time Frame
day 15th, day 30th, 1 month after end of study.
Title
Change in Range of Motion of cervical spine
Description
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.
Time Frame
day 15th, day 30th, 1 month after end of study.
Title
Change in symptoms of nerve root compression
Description
The presence of numbness or weakness of the buttock and leg
Time Frame
day 15th, day 30th, 1 month after end of study.
Title
Change in limitation of daily rountines
Description
Neck Disability Index at day 15th, day 30th, 1 month after end of study.
Time Frame
day 15th, day 30th, 1 month after end of study.
Title
Frequency of AE, SAE.
Description
CTCAE 4.0
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
National Hospital of Traditional Medicine
City
Hanoi
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

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