A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome

NCT03845959 | Completed Phase 2

• 1 other identifier: TD0019.02
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 .

Conditions

Syndrome Pain

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

TD0019.6cap

EXPERIMENTAL

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

Drug: TD0019 oral capsule

TD0019.9cap

EXPERIMENTAL

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

Drug: TD0019 oral capsule

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

TD0019 oral capsule DRUG

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

Also known as: Vien Vai Gay Thai Duong

TD0019.6cap; TD0019.9cap

Placebo oral capsule DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sao Thai Duong Joint Stock Company: lead
• Big Leap Research: collaborator

Study Sites (1)

National Hospital of Traditional Medicine

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three arms: basic dose, 1.5 basic dose and placebo.

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: February 19, 2019
• Study Start: August 30, 2017
• Primary Completion: December 20, 2017
• Study Completion: February 20, 2018
• Last Updated: February 19, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)