Soft Tissue Injuries Clinical Trial
Official title:
Treatment of Posttraumatic Swelling and Pain With Zhi Kang Capsule: a Multicenter, Phase IV Clinical Trial
Zhi Kang Capsule functions for hemostasis and detumescence and can be used for traumatic bleeding, uterine bleeding, hematemesis and hematochezia.This randomized controlled trial was conducted to confirm the efficacy and safety of Zhi Kang Capsule in the treatment of posttraumatic swelling and pain,and also in a wide range of applications by open clinical observation.
Limb fracture is a common disease in the Department of orthopedics, surrounding soft tissue
swelling is the most common phenomenon of fracture and surgical treatment.The swelling, limb
discomfort and increased pain seriously affecting the treatment effect.Therefore, prevention
and treatment of limb swelling and perioperative pain is the main content of the treatment of
fractures.
Post traumatic swelling and pain belong to the category of blood stasis syndrome in
traditional Chinese medicine.Under the guidance of traditional Chinese medicine theory,
traditional Chinese medicine plays a wide range of therapeutic effects, with a syndrome of
multiple characteristics, but from the syndrome to the disease diagnosis and treatment
process, more and more modern evidence based on medicine support are needed.A randomized
controlled trial was carried out in the phase IV clinical trial to confirm the therapeutic
effect of the capsule on posttraumatic swelling and pain. Meanwhile, an open clinical trial
was conducted to evaluate the safety of the capsule in a wide range of applications.
The research subjects are patients with acute limb fractures within 2 weeks.The inclusion
criteria are:(1) diagnosis of limb closed acute fracture, fracture occurred within 14 days,
need for surgical treatment;(2) age ranged from 18 to 80 years old, both male and female;(3)
voluntarily signed the informed consent form as the subjects.Test grouping include the
capsule group and the placebo group.
The research consists of two parts: (1) the core research part: The core study was a
placebo-controlled, randomized, double-blind, multicenter trial designed with 400 units of
sample size, including 200 patients in the Zhi Kang Capsule group and 200 in the placebo
group. The aim of the core study is to evaluate the effectiveness of test drugs. (2) the
expanded research part: on the basis of core research,1800 cases were further divided into
the capsule group. The aim of the expanded study was to evaluate the safety of the capsule in
a large sample.
Criteria for efficacy evaluation include: pain score, swelling degree, lead flow, laboratory
indicators and the first healing rate of surgical incision.All the statistical tests were
two-sided, and the P value was less than or equal to 0.05, which would be considered
statistically significant (except for the special description). The measurement data are
described by means of mean, median, standard deviation, maximum, minimum, 25% and 75%
quantiles; enumeration data or rank data are expressed in frequency and frequency.
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