Treatment of Posttraumatic Swelling and Pain With Zhi Kang Capsule

NCT03363971 | Unknown Phase 4 DMC

• 1 other identifier: PUPH20170988
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Injuries

Keywords

soft tissue, pain

Outcome Measures

Primary Outcomes (1)

• Pain scale

  assess the pain scores with the numerical rating scale (NRS)

  14 days

Secondary Outcomes (1)

• Swelling

  14 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Zhi Kang Capsule DRUG

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.

Experimental group

Simulant agent for Zhi Kang Capsule DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Soft Tissue Injuries; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• People's Hospital Peking University

  Peking University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Peking University People's Hospital

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 6, 2017
• Study Start: March 13, 2017
• Primary Completion: December 20, 2017
• Study Completion: March 13, 2018
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)