Henoch-Schonlein Purpura NephritisCSTCMDTCHSPNNCT02878018
Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis
An observational study of Henoch-Schonlein Purpura Nephritis, run by Liaoning University of Traditional Chinese Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Henoch-Schonlein Purpura Nephritis
- What is being tested?
- Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula and angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to May 2020
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
- Age: 5 to 18 years old (including 5 and 18 year-olds).
- The clinical classification of HSPN includes isolated hematuria, insolated proteinuria, hematuria with proteinuria, and acute glomerulonephritis.
- The ability to provide detailed connection and complete a followup.
- The ability to understand and sign a written informed consent.
Who cannot join
- HSPN with renal insufficiency.
- A clinical classification of HSPN that includes nephritic syndrome, rapidly progressive glomerulonephritis and chronic glomerulonephritis.
- Suffering from serious complications, such as respiratory, digestive, hematological or liver diseases.
- Tumor, infectious diseases, or mental disorders.
- Allergic to TCM use.
- No prescribed medication, poor compliance, or incomplete data affecting the efficacy and safety of these judgments.
- A history of another clinical trial in the previous 2 weeks.
- No consent form signed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Henoch-Schonlein Purpura Nephritis
- Being tested
- Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula, angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant
- Keywords
- Cohort Study, Children, Henoch-Schonlein Purpura Nephritis, Traditional Chinese Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formulaDrug
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.
angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula | |
| 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. Receives: Drug: angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine protein
- Recovery:Urine protein(-).
- Marked effect:Urine protein reduces by 2'+'.
- Effective：Urine protein reduces by 1'+'.
- Ineffective：Urine protein has no changes.
Measured: 2 weeks
24-hour urinary protein excretion
- Recovery:24-hour urinary protein excretion is normal.
- Marked effect:24-hour urinary protein excretion reduction is larger than 50%.
- Effective：24-hour urinary protein excretion reduction is smaller than 50%.
- Ineffective：24-hour urinary protein excretion has no changes.
Measured: 2 weeks
Urine erythrocyte
- Recovery:Urine erythrocyte is normal.
- Marked effect:Urine erythrocyte reduction is larger than 50%.
- Effective:Urine erythrocyte reduction is smaller than 50%.
- Ineffective；Urine erythrocyte has no changes.
Measured: 2 weeks
Creatinine clearance rate and Serum creatinine
Diagnostic criteria of chronic renal failure:
- Creatinine clearance rate<80ml/min;
- Serum creatinine>133μmol/L;
- The patient who have a history of chronic kidney diseases or systemic diseases involving kidney.
Measured: 1 year
Secondary outcomes (2)
Number of patients with hormone therapy
Hormone utilized rate=Number of patients with hormone therapy/The total number of patients
Measured: 3 months
Number of patients with immunosuppressant therapy
Immunosuppressant utilized rate=Number of patients with immunosuppressant therapy/The total number of patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2019
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Henoch-Schonlein Purpura NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Liaoning University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Shengjing Hospital
- Responsible party
- Principal investigator, Zhang Jun, Liaoning University of Traditional Chinese Medicine
- Investigators
- jun zhang, master, Study chair, Affiliated Hospital of Liaoning University of Traditional Chinese Medicinejing lv, master, Study director, Affiliated Hospital of Liaoning University of Traditional Chinese Medicineshaoqing zhang, doctor, Principal investigator, Affiliated Hospital of Liaoning University of Traditional Chinese Medicineguanqi yang, doctor, Principal investigator, Affiliated Hospital of Liaoning University of Traditional Chinese Medicineshuang pang, doctor, Principal investigator, Affiliated Hospital of Liaoning University of Traditional Chinese Medicinebinyu wu, master, Principal investigator, Shengjing Hospitalyaoguo zhang, master, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878018
- Sponsor's protocol ID
- ZJ16813
- Acronym
- CSTCMDTCHSPN
- Status last verified
- Mar 2019
- First submitted
- 17 Aug 2016
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Central Database of Clinical Evaluation of China Academy of Chinese Medicine Science
Publications
Zhang J, Lv J, Pang S, Bai X, Yuan F, Wu Y, Jiang H, Yang G, Zhang S. Chinese herbal medicine for the treatment of Henoch-Schonlein purpura nephritis in children: A prospective cohort study protocol. Medicine (Baltimore). 2018 Jun;97(24):e11064. doi: 10.1097/MD.0000000000011064.
PubMed 29901610
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study on Traditional Chinese Medicine Diagnosis and Treatment of Children With Henoch-Schonlein Purpura Nephritis
- ClinicalTrials.gov ID
- NCT02878018
- Acronym / sponsor ID
- CSTCMDTCHSPN / ZJ16813
- Conditions
- Henoch-Schonlein Purpura Nephritis
- Keywords
- Cohort Study, Children, Henoch-Schonlein Purpura Nephritis, Traditional Chinese Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Liaoning University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Shengjing Hospital
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- May 2020 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM intervention | – | Drug: Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formulaParticipants 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. |
| WM conventional intervention | – | Drug: angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressantThe 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
- Age: 5 to 18 years old (including 5 and 18 year-olds).
- The clinical classification of HSPN includes isolated hematuria, insolated proteinuria, hematuria with proteinuria, and acute glomerulonephritis.
- The ability to provide detailed connection and complete a followup.
- The ability to understand and sign a written informed consent.
Key exclusion criteria (8 listed)
- HSPN with renal insufficiency.
- A clinical classification of HSPN that includes nephritic syndrome, rapidly progressive glomerulonephritis and chronic glomerulonephritis.
- Suffering from serious complications, such as respiratory, digestive, hematological or liver diseases.
- Tumor, infectious diseases, or mental disorders.
- Allergic to TCM use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formulaQi-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. | Drug | TCM intervention |
| angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressantprednisone 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. | Drug | WM conventional intervention |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Number of patients with hormone therapy
Time frame: 3 months
Number of patients with immunosuppressant therapy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Derived from this study: PubMed 29901610Zhang J, Lv J, Pang S, Bai X, Yuan F, Wu Y, Jiang H, Yang G, Zhang S. Chinese herbal medicine for the treatment of Henoch-Schonlein purpura nephritis in children: A prospective cohort study protocol. Medicine (Baltimore). 2018 Jun;97(24):e11064. doi: 10.1097/MD.0000000000011064.
- Individual participant dataSharing planned: Yes. The Central Database of Clinical Evaluation of China Academy of Chinese Medicine Science
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jun zhang, master study chair
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
jing lv, master study director
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
shaoqing zhang, doctor principal investigator
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Henoch-Schonlein Purpura Nephritis, run by Liaoning University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine protein (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02878018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.