The Safety and Efficacy of Micro-energy Ultrasound in the Treatment of Renal Insufficiency After Renal Transplantation
NCT ID: NCT04119427
Last Updated: 2020-05-12
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
NA
90 participants
INTERVENTIONAL
2020-05-01
2021-12-31
Brief Summary
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Detailed Description
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2. Study design: This is a randomized, double-blind, controlled, multicenter clinical trial.
3. Study objects: Patients with mild to moderate renal insufficiency after renal transplantation.
4. Number of samples: 90
5. Main study center: Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
6. Treatments:
Test group: After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed.Patients were treated twice a week for 6 weeks.
Control group: The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test Group
After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
ultrasonic therapeutic apparatus 1
After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
Control Group
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
ultrasonic therapeutic apparatus 2
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Interventions
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ultrasonic therapeutic apparatus 1
After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
ultrasonic therapeutic apparatus 2
The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
Eligibility Criteria
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Inclusion Criteria
2. Mild to moderate renal insufficiency (creatinine less than 442umol / L);
3. Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign the informed consent form.
Exclusion Criteria
2. Blood routine suggests acute and chronic blood system diseases;
3. B-ultrasound suggests transplanting hydronephrosis;
4. Uncontrollable patients with diabetes, hypertension, and cardiovascular disease;
5. The investigator determined that it is not suitable for this clinical trial.
18 Years
60 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-194
Identifier Type: -
Identifier Source: org_study_id
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