A Phase 4 interventional study of Zhi Kang Capsule and Simulant agent for Zhi Kang Capsule in Soft Tissue Injuries, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by Peking University People's Hospital · Phase 4, Interventional, and Treatment
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.
64 studies on the registry are indexed under Soft Tissue Injuries; 7 are open to participants now.
This study's planned enrollment of 2,200 is above the median of 60 across 51 interventional studies indexed under Soft Tissue Injuries.
Browse Soft Tissue Injuries studies →Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Pain scale
assess the pain scores with the numerical rating scale (NRS)
Time frame: 14 days
Swelling
assess the swelling degree
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2017 (actual). Primary completion is estimated for Dec 2017, 9 months after the start.
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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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