Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis (CSTCMDTCHSPN)

March 1, 2019 updated by: Zhang Jun, Liaoning University of Traditional Chinese Medicine
Henoch-Schonlein purpura nephritis(HSPN) is one of the most common secondary glomerulonephritis in children. A large, prospective, multicenter cohort study is being conducted in three institutions. Eligible Henoch-Schönlein purpura nephritis children will be classified as the experimental group (n=300) and the control group (n=300) based on the interventions they receive. Patients taking Chinese herbal formula will be in the experimental group, and those taking Western medicine will be in the control group. The entire study will last 60 weeks, including a 12-week observation period and a followup at 12 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background: Henoch-Schönlein purpura nephritis involves the renal impairment of Henoch-Schönlein purpura and can easily relapse into life-threatening late nephropathy in severe cases. Although there is a lack of validated evidence for its effectiveness, traditional Chinese medicine is the most commonly used method in China to treat Henoch-Schönlein purpura nephritis. We report the protocol of a prospective cohort trial using traditional Chinese medicine to investigate the effectiveness, safety and advantages for children with Henoch-Schönlein purpura nephritis.

Methods/Design: A large, prospective, multicenter cohort study is being conducted in three institutions. Eligible Henoch-Schönlein purpura nephritis children will be classified as the experimental group (n=300) and the control group (n=300) based on the interventions they receive. Patients taking Chinese herbal formula will be in the experimental group, and those taking Western medicine will be in the control group. The entire study will last 60 weeks, including a 12-week observation period and a followup at 12 months. Seven visits will be scheduled for each participant with visits in week 0, week 2, week 4, week 6, week 8, week 10 and week 12. The primary outcomes include the remission rate and the recurrence rate. The secondary outcomes include the urine erythrocyte effectiveness, the urine protein effectiveness, the hormone usage rate, the immunosuppressant usage rate, and the incidence rate of renal failure. Safety outcomes and any adverse reactions will be recorded during the study.

Discussion: This study will determine whether the Chinese herbal formula is helpful for treating Henoch-Schönlein purpura nephritis in children. The findings will provide a basis for further confirmatory studies.

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110032
        • Zhang Jun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with purpura nephritis who are treated in Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shengjing Hospital of China Medical University and The First Hospital of China Medical University will be regarded as the objects of study.

Description

Inclusion criteria

  1. A diagnosis of HSPN as well as three major constitution types (Heat-Toxin, Wet-Heat, Qi-Deficiency with Blood-Stasis) according to WM and TCM.
  2. Age: 5 to 18 years old (including 5 and 18 year-olds).
  3. The clinical classification of HSPN includes isolated hematuria, insolated proteinuria, hematuria with proteinuria, and acute glomerulonephritis.
  4. The ability to provide detailed connection and complete a followup.
  5. The ability to understand and sign a written informed consent.

Exclusion criteria

  1. HSPN with renal insufficiency.
  2. A clinical classification of HSPN that includes nephritic syndrome, rapidly progressive glomerulonephritis and chronic glomerulonephritis.
  3. Suffering from serious complications, such as respiratory, digestive, hematological or liver diseases.
  4. Tumor, infectious diseases, or mental disorders.
  5. Allergic to TCM use.
  6. No prescribed medication, poor compliance, or incomplete data affecting the efficacy and safety of these judgments.
  7. A history of another clinical trial in the previous 2 weeks.
  8. No consent form signed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TCM intervention
Participants with HSPN of the Heat-Toxin type will take the Qi-Ji Shen-Kang formula. HSPN patients of the Wet-Heat type will take the Zhu-Bai formula. Those of Qi-Deficiency with Blood-Stasis type will take the Yu-Shen formula.
Drug: Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula
Qi-Ji Shen-Kang formula:15g of field thistle,10g of common edelweiss herb,10g of spreading hedyotis herb,10g ofYunnan manyleaf Paris rhizome,10g of hairyvein agrimonia herb,10g of the root bark of the tree peony,15g of root of red rooted salvia, and 15g ofmembranous mikvetch root.Zhu-Bai formula:10g of glabrous greenbrier rhizome,5g of Chinese atractylodes rhizome,10g of amur corktree bark,10g of common edelweiss her),10g of field thistle,10g of lalang grass rhizome,10g of garden burnet root,5g of longbract cattail pollen,5g of rehmanniae radix, and 5g of Chinese angelica root.Yu-Shen formula:15g of membranous mikvetch root,10g of heterophylla falsestarwort root,10g of field thistle,10g of cogongrass rhizome,10g of spreading hedyotis herb,10g of root of red rooted salvia,10g of fresh root of rehmannia,10g of Asian puccoon,10g of wormwoodlike motherwort herb,10g of common cockscomb inflorescence,10g of gordon euyale,10g of root bark of the tree peony, and 5g of licorice root.
WM conventional intervention
The WM conventional intervention, recommended by the Chinese Medical Association's (CMA) Scientific Statement, includes angiotensin-converting enzyme (ACE) inhibitor, adrenergic receptor binder (ARB), adrenal cortical hormone, Tripterygium wilfordii polyglycosidium and an immunosuppressant.
Drug: angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant
prednisone at a dose of 1-1.5 mg/(kg·d) and Tripterygium wilfordii polyglycosidium at a dose of 1 mg/(kg·d). For each patient, the specific Western medicines used and their doses may be adjusted at the discretion of his or her physician, but the classes cannot be changed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine protein
Time Frame: 2 weeks
  1. Recovery:Urine protein(-).
  2. Marked effect:Urine protein reduces by 2'+'.
  3. Effective：Urine protein reduces by 1'+'.
  4. Ineffective：Urine protein has no changes.
2 weeks
24-hour urinary protein excretion
Time Frame: 2 weeks
  1. Recovery:24-hour urinary protein excretion is normal.
  2. Marked effect:24-hour urinary protein excretion reduction is larger than 50%.
  3. Effective：24-hour urinary protein excretion reduction is smaller than 50%.
  4. Ineffective：24-hour urinary protein excretion has no changes.
2 weeks
Urine erythrocyte
Time Frame: 2 weeks
  1. Recovery:Urine erythrocyte is normal.
  2. Marked effect:Urine erythrocyte reduction is larger than 50%.
  3. Effective:Urine erythrocyte reduction is smaller than 50%.
  4. Ineffective；Urine erythrocyte has no changes.
2 weeks
Creatinine clearance rate and Serum creatinine
Time Frame: 1 year

Diagnostic criteria of chronic renal failure:

  1. Creatinine clearance rate<80ml/min;
  2. Serum creatinine>133μmol/L;
  3. The patient who have a history of chronic kidney diseases or systemic diseases involving kidney.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with hormone therapy
Time Frame: 3 months
Hormone utilized rate=Number of patients with hormone therapy/The total number of patients
3 months
Number of patients with immunosuppressant therapy
Time Frame: 3 months
Immunosuppressant utilized rate=Number of patients with immunosuppressant therapy/The total number of patients
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaoning University of Traditional Chinese Medicine

Collaborators

Shengjing Hospital
First Hospital of China Medical University

Investigators

  • Study Chair: jun zhang, master, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Study Director: jing lv, master, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Principal Investigator: shaoqing zhang, doctor, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Principal Investigator: guanqi yang, doctor, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Principal Investigator: shuang pang, doctor, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Principal Investigator: binyu wu, master, Shengjing Hospital
  • Principal Investigator: yaoguo zhang, master, First Hospital of China Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (ESTIMATE)

August 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJ16813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Central Database of Clinical Evaluation of China Academy of Chinese Medicine Science

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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