Syndrome PainPhase 2NCT03845959
A Trial of TD0019 in Treatment of Cervical Scapulohumeral Syndrome
A Phase 2 study testing TD0019 oral capsule in people with Syndrome Pain, run by Sao Thai Duong Joint Stock Company at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Syndrome Pain
- What is being tested?
- TD0019 oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteVietnam
- Study dates
- 30 Aug 2017to 20 Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
.
Read the 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.
- Conditions
- Syndrome Pain
- Being tested
- TD0019 oral capsule, Placebo oral capsule
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TD0019 oral capsuleDrug
Also called Vien Vai Gay Thai Duong
TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.
Placebo oral capsuleDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| TD0019.6cap | Experimental | estimated dose, 2 oral capsules/time x 3 times/day Receives: Drug: TD0019 oral capsule |
| TD0019.9cap | Experimental | 1.5 times of estimated dose 2 oral capsules/time x 3 times/day Receives: Drug: TD0019 oral capsule |
| Placebo | Placebo comparator | Placebo 2 placebo oral capsules /time x 3 times/day Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: day 15th, day 30th, 1 month after end of study.
Frequency of AE, SAE.
CTCAE 4.0
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start30 Aug 2017
- Primary completion20 Dec 2017
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Syndrome PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arms: basic dose, 1.5 basic dose and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Thai Duong Joint Stock Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Big Leap Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845959
- Sponsor's protocol ID
- TD0019.02
- Status last verified
- Feb 2018
- First submitted
- 10 Jan 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03845959
- Acronym / sponsor ID
- TD0019.02
- Conditions
- Syndrome Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Sao Thai Duong Joint Stock CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Big Leap Research
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three arms: basic dose, 1.5 basic dose and placebo.
| Arm | Type | Receives |
|---|---|---|
| TD0019.6cap | Experimental | Drug: TD0019 oral capsuleestimated dose, 2 oral capsules/time x 3 times/day |
| TD0019.9cap | Experimental | Drug: TD0019 oral capsule1.5 times of estimated dose 2 oral capsules/time x 3 times/day |
| Placebo | Placebo comparator | Drug: Placebo oral capsulePlacebo 2 placebo oral capsules /time x 3 times/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TD0019 oral capsuleAlso: Vien Vai Gay Thai DuongTD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal. | Drug | TD0019.6cap, TD0019.9cap |
| Placebo oral capsulePlacebo | Drug | Placebo |
Primary outcome
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
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.
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
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.
Frequency of AE, SAE.
Time frame: 1 month
CTCAE 4.0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TD0019 oral capsule in people with Syndrome Pain, run by Sao Thai Duong Joint Stock Company at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.