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Treatment of Posttraumatic Swelling and Pain With Zhi Kang Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03363971
Recruitment Status : Unknown
Verified December 2017 by baoguojiang, Peking University People's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
baoguojiang, Peking University People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Injuries Drug: Zhi Kang Capsule Drug: Simulant agent for Zhi Kang Capsule Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Treatment of Posttraumatic Swelling and Pain With Zhi Kang Capsule: a Multicenter, Phase IV Clinical Trial
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : December 20, 2017
Estimated Study Completion Date : March 13, 2018

Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Placebo Comparator: 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.
Drug: 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.




Primary Outcome Measures :
  1. Pain scale [ Time Frame: 14 days ]
    assess the pain scores with the numerical rating scale (NRS)


Secondary Outcome Measures :
  1. Swelling [ Time Frame: 14 days ]
    assess the swelling degree



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of limb closed acute fracture, fracture occurred within 14 days, need for surgical treatment;
  • age ranged from 18 to 80 years old, both male and female;
  • voluntarily signed the informed consent form as the subjects.

Exclusion Criteria:

  • open fracture
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363971


Locations
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China, Beijing
Peking University People's Hospital
Peking, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Director: People's Hospital Peking University Peking University
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Responsible Party: baoguojiang, Director of Peking University People's Hospital, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03363971    
Other Study ID Numbers: PUPH20170988
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by baoguojiang, Peking University People's Hospital:
soft tissue, pain
Additional relevant MeSH terms:
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Soft Tissue Injuries
Wounds and Injuries