Treatment of Posttraumatic Swelling and Pain With Zhi Kang Capsule

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.

Study Overview

• Status: Unknown
• Conditions: Soft Tissue Injuries
• Intervention / Treatment: Drug: Zhi Kang Capsule; Drug: Simulant agent for Zhi Kang Capsule

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale	assess the pain scores with the numerical rating scale (NRS)	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling	assess the swelling degree	14 days

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Director: People's Hospital Peking University, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2017
• Primary Completion (Anticipated): December 20, 2017
• Study Completion (Anticipated): March 13, 2018

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: soft tissue, pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Soft Tissue Injuries
• Other Study ID Numbers: PUPH20170988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No