Treatment of Posttraumatic Swelling and Pain With Zhi Kang Capsule
NCT ID: NCT03363971
Last Updated: 2017-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
2200 participants
INTERVENTIONAL
2017-03-13
2018-03-13
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental group
Zhi Kang Capsule, 0.3g/capsule, oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery,treatment for 6 weeks.
Zhi Kang Capsule
0.3g/capsule, oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery; treatment for 6 weeks.
Control group
Simulant agent for Zhi Kang Capsule,consistent with the appearance, color, odor, and usage of the Zhi Kang capsule, so that it can not be distinguished.oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery, treatment for 6 weeks.
Simulant agent for Zhi Kang Capsule
0.3g/capsule,oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery; treatment for 6 weeks.
Interventions
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Zhi Kang Capsule
0.3g/capsule, oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery; treatment for 6 weeks.
Simulant agent for Zhi Kang Capsule
0.3g/capsule,oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery; treatment for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* age ranged from 18 to 80 years old, both male and female;
* voluntarily signed the informed consent form as the subjects.
Exclusion Criteria
* multiple fractures (more than 1) or with vascular, nerve and visceral injuries
* severe primary diseases associated with heart, brain, liver, kidney, lung and hematopoietic system
* allergic constitution, mental patients
* patients with severe gastrointestinal diseases, such as ulcers; patients with severe metabolic diseases
* patients with history of alcohol addiction or drug abuse
* patients with poor compliance
* lactating women, women of pregnancy or childbearing age or male patients, do not agree to adopt effective contraceptive measures during the study period
* participants who participated in other clinical trials within the first three months of the study
18 Years
80 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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baoguojiang
Director of Peking University People's Hospital
Principal Investigators
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People's Hospital Peking University
Role: STUDY_DIRECTOR
Peking University
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PUPH20170988
Identifier Type: -
Identifier Source: org_study_id