Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication | Experimental | Extract of Helminthostachys zeylanica(L.)Hook in capsule, 1gm/time, 3 times daily |
|
| Starch | Placebo Comparator | Starch in capsule,1gm/time, 3 times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helminthostachys zeylanica(L.)Hook | Drug | Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of American Orthopedic Foot and Ankle(AOFAS) Score | Score to evaluate ankle and hindfoot function, from 0-100 points, healthy ankle 100 points | 1st day of study, 10~14th days of study, 43th days of study |
| Change of Ankle volume | figure-of-8 method | 1st day of study, 10~14th days of study, 43th days of study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1st day of study, 43th days of study |
| Fracture Healing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ching Liang Hsieh, MD, PhD | Graduate Institute of Integrated Medicine,China Medical University,Taiwan. | Study Director |
| Lun Chien Lo, MD, PhD | School of Chinese Medicine,China Medical University,Taiwan. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChangHua Christian Hospital | Changhua | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28169537 | Background | 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. |
| Label | URL |
|---|---|
| paper link | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided
Treatment group and Control group
Not provided
Not provided
Double-blinded randomized
| Starch | Drug | Starch in capsule, 1gm/time, 3 times daily |
|
|
ankle radiography, bone callus formation and continuity of callus
| 1st day of study, 43th days of study |
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |