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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02878018
Date of registration:	17/08/2016
Prospective Registration:	Yes
Primary sponsor:	Liaoning University of Traditional Chinese Medicine
Public title:	Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis CSTCMDTCHSPN
Scientific title:	Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis
Date of first enrolment:	September 2016
Target sample size:	600
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT02878018
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
China

Contacts

Name:	yaoguo zhang, master
Address:
Telephone:
Email:
Affiliation:	First Hospital of China Medical University

Name:	binyu wu, master
Address:
Telephone:
Email:
Affiliation:	Shengjing Hospital

Name:	guanqi yang, doctor
Address:
Telephone:
Email:
Affiliation:	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Name:	jing lv, master
Address:
Telephone:
Email:
Affiliation:	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Name:	jun zhang, master
Address:
Telephone:
Email:
Affiliation:	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Name:	shaoqing zhang, doctor
Address:
Telephone:
Email:
Affiliation:	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Name:	shuang pang, doctor
Address:
Telephone:
Email:
Affiliation:	Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

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.

Age minimum: 5 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Henoch-Schonlein Purpura Nephritis

Intervention(s)

Drug: angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant

Drug: Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula

Primary Outcome(s)

Urine protein [Time Frame: 2 weeks]

Creatinine clearance rate and Serum creatinine [Time Frame: 1 year]

24-hour urinary protein excretion [Time Frame: 2 weeks]

Urine erythrocyte [Time Frame: 2 weeks]

Secondary Outcome(s)

Number of patients with immunosuppressant therapy [Time Frame: 3 months]

Number of patients with hormone therapy [Time Frame: 3 months]

Secondary ID(s)

ZJ16813

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

First Hospital of China Medical University

Shengjing Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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