Ankle FracturesPhase 1/2NCT03805347
The Therapeutic Effect of Dau-Di-Wu-Gong in Patient With Ankle Fracture
A Phase 1/2 study testing Helminthostachys zeylanica(L.)Hook and Starch in people with Ankle Fractures, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Ankle fracture is one of most common bone fracture in Taiwan, although ankle fracture can be treated by surgical operation, local edema, pain and wound poor healing always is noted, according to the investigator's knowledge, no good therapeutic methods to treat mention-above symptoms until now. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Helminthostachys zeylanica(L.)Hook and Starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2020to 11 Jan 2021
- Phase
- Phase 1/2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-75 year-old male or female with acute ankle fractures with surgical indication (Joint line displacement >2mm ; fracture dislocation)
Who cannot join
- Previous skin disease, DM or peripheral vessel disease with local foot amputation.
- Previous ankle surgery, old ankle fracture, or open fracture.
- Liver or renal dysfunction, and cardiorespiratory failure.
- Surgical infection after surgery.
- Patient refuse or can't finish the treatment course
- Patient with cancer
- Pregnancy
- HIV positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture
Ankle fracture is one of most common bone fracture in Taiwan, although ankle fracture can be treated by surgical operation, local edema, pain and wound poor healing always is noted, according to the investigator's knowledge, no good therapeutic methods to treat mention-above symptoms until now. Helminthostachys zeylanica(L.)Hook, also called Dau-Di-U-Gon has anti-inflammation, calm down heat and detoxication, and anti-edema. People in Taiwan often uses Helminthostachys zeylanica(L.)Hook to treat bone and tendon pain, and its Ugonin component of Helminthostachys zeylanica(L.)Hook also is proved that has analgesia and ant-inflammation. Therefore, the purpose of the present study was to design a randomized, double-blind, controlled study to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical operation in patients with ankle fracture.
Read the detailed description
the purpose of the present study was to design a randomized, double-blind, controlled study to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical operation in patients with ankle fracture. The primary outcome measure was the scores change of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale, and tape (figure-of-eight) methods. Secondary outcome measure was the level changes of bone metabolism in peripheral blood, four diagnostic method, and the changes of ankle X-ray findings.
- Conditions
- Ankle Fractures
- Being tested
- Helminthostachys zeylanica(L.)Hook, Starch
- Keywords
- Ankle fracture, Helminthostachys zeylanica(L.)Hook, Clinical trials, Functional recovery
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helminthostachys zeylanica(L.)HookDrug
Also called Dao-Di-Wu-Gong
Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
StarchDrug
Also called Placebo
Starch in capsule, 1gm/time, 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Medication | Experimental | Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily Receives: Drug: Helminthostachys zeylanica(L.)Hook |
| Starch | Placebo comparator | Starch in capsule，1gm/time, 3 times daily Receives: Drug: Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of American Orthopedic Foot and Ankle(AOFAS) Score
Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points
Measured: 1st day of study, 10~14th days of study, 43th days of study
Change of Ankle volume
figure-of-8 method
Measured: 1st day of study, 10~14th days of study, 43th days of study
Secondary outcomes (2)
Level of bone turnover marker
Alkaline Phosphatase(ALP)normal range between 37 and 116 U/L; type 1 procollagen amino-terminal-propeptide (P1NP), normal range between 20-42 ng/L
Measured: 1st day of study, 43th days of study
Fracture Healing
ankle radiography, bone callus formation and continuity of callus
Measured: 1st day of study, 43th days of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start12 Dec 2020
- Primary completion11 Jan 2021
- Study completion11 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group and Control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching Liang Hsieh, MD, PhD, Study director, Graduate Institute of Integrated Medicine,China Medical University,Taiwan.Lun Chien Lo, MD, PhD, Principal investigator, School of Chinese Medicine,China Medical University,Taiwan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805347
- Sponsor's protocol ID
- 180917
- Status last verified
- Aug 2021
- First submitted
- 4 Jan 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang YL, Shen CC, Shen YC, Chiou WF, Chen CC. Anti-inflammatory and Antiosteoporosis Flavonoids from the Rhizomes of Helminthostachys zeylanica. J Nat Prod. 2017 Feb 24;80(2):246-253. doi: 10.1021/acs.jnatprod.5b01164. Epub 2017 Feb 7.
PubMed 28169537
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Helminthostachys Zeylanica(L.)Hook on Functional Recovery After Surgical Operation in Patients With Ankle Fracture
- ClinicalTrials.gov ID
- NCT03805347
- Acronym / sponsor ID
- 180917
- Conditions
- Ankle Fractures
- Keywords
- Ankle fracture, Helminthostachys zeylanica(L.)Hook, Clinical trials, Functional recovery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2021 (actual)
- First posted
- 15 Jan 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.
Ankle fracture is one of most common bone fracture in Taiwan, although ankle fracture can be treated by surgical operation, local edema, pain and wound poor healing always is noted, according to the investigator's knowledge, no good therapeutic methods to treat mention-above symptoms until now. Helminthostachys zeylanica(L.)Hook, also called Dau-Di-U-Gon has anti-inflammation, calm down heat and detoxication, and anti-edema. People in Taiwan often uses Helminthostachys zeylanica(L.)Hook to treat bone and tendon pain, and its Ugonin component of Helminthostachys zeylanica(L.)Hook also is proved that has analgesia and ant-inflammation. Therefore, the purpose of the present study was to design a randomized, double-blind, controlled study to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical operation in patients with ankle fracture.
Detailed description
the purpose of the present study was to design a randomized, double-blind, controlled study to evaluate functional recovery effect of Helminthostachys zeylanica(L.)Hook after surgical operation in patients with ankle fracture. The primary outcome measure was the scores change of American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale, and tape (figure-of-eight) methods. Secondary outcome measure was the level changes of bone metabolism in peripheral blood, four diagnostic method, and the changes of ankle X-ray findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Treatment group and Control group
| Arm | Type | Receives |
|---|---|---|
| Medication | Experimental | Drug: Helminthostachys zeylanica(L.)HookExtract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily |
| Starch | Placebo comparator | Drug: StarchStarch in capsule，1gm/time, 3 times daily |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20-75 year-old male or female with acute ankle fractures with surgical indication (Joint line displacement >2mm ; fracture dislocation)
Key exclusion criteria (8 listed)
- Previous skin disease, DM or peripheral vessel disease with local foot amputation.
- Previous ankle surgery, old ankle fracture, or open fracture.
- Liver or renal dysfunction, and cardiorespiratory failure.
- Surgical infection after surgery.
- Patient refuse or can't finish the treatment course
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 |
|---|---|---|
| Helminthostachys zeylanica(L.)HookAlso: Dao-Di-Wu-GongExtract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily | Drug | Medication |
| StarchAlso: PlaceboStarch in capsule, 1gm/time, 3 times daily | Drug | Starch |
Primary outcome
Change of American Orthopedic Foot and Ankle(AOFAS) Score
Time frame: 1st day of study, 10~14th days of study, 43th days of study
Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points
Change of Ankle volume
Time frame: 1st day of study, 10~14th days of study, 43th days of study
figure-of-8 method
2 secondary outcomes
Level of bone turnover marker
Time frame: 1st day of study, 43th days of study
Fracture Healing
Time frame: 1st day of study, 43th days of study
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 9 Aug 2021.
- Background: PubMed 28169537Huang YL, Shen CC, Shen YC, Chiou WF, Chen CC. Anti-inflammatory and Antiosteoporosis Flavonoids from the Rhizomes of Helminthostachys zeylanica. J Nat Prod. 2017 Feb 24;80(2):246-253. doi: 10.1021/acs.jnatprod.5b01164. Epub 2017 Feb 7.
- paper linkLink provided by the sponsor.
- 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.
Ching Liang Hsieh, MD, PhD study director
Graduate Institute of Integrated Medicine,China Medical University,Taiwan.
Lun Chien Lo, MD, PhD principal investigator
School of Chinese Medicine,China Medical University,Taiwan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Helminthostachys zeylanica(L.)Hook and Starch in people with Ankle Fractures, run by Changhua Christian Hospital at 1 site in Taiwan.
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 1 inclusion and 8 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 9 Aug 2021. 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 Taiwan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 of American Orthopedic Foot and Ankle(AOFAS) Score (time frame: 1st day of study, 10~14th days of study, 43th days of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03805347, which also lists 1 linked publication.
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 9 Aug 2021.