A Phase 2 interventional study of Lymphomyosot and Placebo remedy in Ankle Injuries and Fracture, sponsored by Shaare Zedek Medical Center. Suspended at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.
Sponsored by Shaare Zedek Medical Center · Phase 2, Interventional, and Treatment
Ankle fractures are invariably complicated by severe soft-tissue swelling which can significantly prevent surgical repair (open reduction and internal fixation - ORIF) of the fractured bone for up to two weeks. The delay in surgical treatment can increase the risk for local skin and bone complications, as well as for deep venous thrombosis. Lymphomyosot® is a non-prescription, homeopathic complex drug which has been used for more than 70 years throughout Europe and the U.S., primarily for tissue edema and swelling.
This is a randomized, placebo-controlled, double blind pilot study evaluating the effectiveness of homeopathic combination drug Lymphomyosot® compared to placebo treatment. The study will take place at the Shaare Zedek Medical Center in Jerusalem, Israel. Adult patients (age 18 years and older) admitted to the orthopedic department with acute ankle fractures which require ORIF repair will be assessed for inclusion in this study.
The primary outcome measure to be evaluated is the fracture-ORIF waiting period. Other measures to be evaluated are: peri-malleolar circumference; pain (as measured by NRS and analgesic use); duration of hospital stay; and complications such as poor wound healing, blisters, and the development of deep vein thrombosis.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's planned enrollment of 60 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Shaare Zedek Medical Center is the lead sponsor of 191 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
homeopathic remedy
Drug: Lymphomyosot
identical in color, constituency and taste to true remedy
Drug: Placebo remedy
20 drops X3/day, until discharge
20 drops X3/day, until discharge
To compare the effect of Lymphomyosot on the duration of time from fracture to ORIF surgery, to placebo medication.
Time frame: 3 weeks
To compare the effect of Lymphomyosot® on the development of peri-malleolar edema following ankle fracture surgery, to placebo medication.
Time frame: 3 weeks
To compare the effect of Lymphomyosot on pain following ankle fracture, to placebo medication.
Time frame: 3 weeks
To compare the effect of Lymphomyosot on Hospitalization time between the verum and the placebo group.
Time frame: 3 weeks
To compare the effect of Lymphomyosot on complication rate (wound healing disturbance, wound infection, blistering, deep vein thrombosis).
Time frame: 3 weeks
This study is suspended, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Shaare Zedek Medical Center