Type 2 Diabetes MellitusPhase 2/3NCT03164785
Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease
A Phase 2/3 study testing Jinshuibao Capsule in people with Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease
- What is being tested?
- Jinshuibao Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2017to 8 Dec 2022
- Phase
- Phase 2/3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with written informed consent.
- Type 2 diabetes according to 1999 WHO criteria.
- Age: 30-75 years.
- HbA1c < 11%.
- Stage III diabetic kidney disease:
- 5.1 microalbuminuria: 30 mg / g < urinary albumin creatinine ratio (ACR) < 300 mg / g, positive for at least two in three times.
Show all 9Show fewer
- 5.2 renal function: eGFR ≧ 30 ml / min / 1.73 ㎡.
- Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months.
- Childbearing-age women with contraceptive measures.
Who cannot join
- Type 1 Diabetes Mellitus.
- Non-diabetic urinary system diseases (Urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.)
- Other serious diseases [severe hypertension ((defined as SBP > 200 mmHg and/or DBP > 110 mmHg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x UNL), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.]
- Allergic to Cordyceps sinensis, use of ACEIs, any use of Cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc.
- Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.
- Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
About this study
Official title: Efficacy and Safety of Jinshuibao Capsule as Add-on Therapy to Angiotensin II Receptor Blockers on Diabetic Kidney Disease in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.
Read the detailed description
Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including ACEI and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot completely block its development. Cordyceps sinensis is a traditional Chinese medicine and Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However, its clinical application in diabetic kidney disease is not well-defined so far. The aim of this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in T2DM.
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease
- Being tested
- Jinshuibao Capsule
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jinshuibao CapsuleDrug
Also called Jinshuibao Jiaonang, Cordyceps sinensis, Artificial Cordyceps sinensis powder
1.98g t.i.d. p.o. for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treatment：subjects receive Jinshuibao Capsule. ARB will be continued as a routine therapy.
Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling Receives: Drug: Jinshuibao Capsule |
| Control Group | No intervention | Patients receive a standard dose of ARB drug as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine albumin creatine ratio (ACR).
First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial).
Measured: Baseline and 1,2,3,6 months.
Secondary outcomes (11)
The incidence of ≧30% decline in eGFR from baseline.
Monitoring changes in glomerular functions measured in estimated glomerular filtration rate (eGFR) [CKD-EPI creatinine-cystatin equation (2012)].
Measured: half a year
Change in urine α1-microglobulin.
Measured: Baseline and 1,2,3,6 months.
Change in urine β2-microglobulin.
Measured: Baseline and 1,2,3,6 months.
Change in urine N-acetyl-β-D-glucosidase.
Measured: Baseline and 1,2,3,6 months.
Change in urine neutrophil gelatinase-associated lipocalin.
Measured: Baseline and 1,2,3,6 months.
Change in inflammation level.
Change in hs-CRP level.
Measured: Baseline and 1,2,3,6 months.
Change in HbA1c.
Measured: Baseline and 1,3,6 months.
Change in blood pressure control.
Measured: Baseline and 1,2,3,6 months.
Change in blood lipids.
Measured: Baseline and 1,3,6 months.
Life quality evaluation
Change in SF-36 Scale score.
Measured: Baseline and 6 months.
Incidence of Treatment-Emergent Adverse Events
Treatment-related adverse events as assessed by deterioration of liver functions with other reasons excluded, self-report of gastrointestinal symptoms associated with drug intake, etc.
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start24 Jul 2017
- Primary completion26 Sep 2020
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguang Zhou, Second Xiangya Hospital of Central South University
- Investigators
- Zhiguang Zhou, MD/PhD, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164785
- Sponsor's protocol ID
- JSB201601
- Status last verified
- Jan 2024
- First submitted
- 8 May 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results belongs to the principal investigator and collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Jinshuibao Capsule as Add-on Therapy to Angiotensin II Receptor Blockers on Diabetic Kidney Disease in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03164785
- Acronym / sponsor ID
- JSB201601
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 24 May 2017 (actual)
- 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.
The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.
Detailed description
Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including ACEI and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot completely block its development. Cordyceps sinensis is a traditional Chinese medicine and Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However, its clinical application in diabetic kidney disease is not well-defined so far. The aim of this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Jinshuibao CapsuleTreatment：subjects receive Jinshuibao Capsule. ARB will be continued as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling |
| Control Group | No intervention | –Patients receive a standard dose of ARB drug as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with written informed consent.
- Type 2 diabetes according to 1999 WHO criteria.
- Age: 30-75 years.
- HbA1c < 11%.
- Stage III diabetic kidney disease:
Key exclusion criteria (6 listed)
- Type 1 Diabetes Mellitus.
- Non-diabetic urinary system diseases (Urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.)
- Other serious diseases [severe hypertension ((defined as SBP > 200 mmHg and/or DBP > 110 mmHg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x UNL), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.]
- Allergic to Cordyceps sinensis, use of ACEIs, any use of Cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc.
- Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.
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 |
|---|---|---|
| Jinshuibao CapsuleAlso: Jinshuibao Jiaonang, Cordyceps sinensis, Artificial Cordyceps sinensis powder1.98g t.i.d. p.o. for 6 months | Drug | Treatment Group |
Primary outcome
Change in urine albumin creatine ratio (ACR).
Time frame: Baseline and 1,2,3,6 months.
First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial).
11 secondary outcomes
The incidence of ≧30% decline in eGFR from baseline.
Time frame: half a year
Change in urine α1-microglobulin.
Time frame: Baseline and 1,2,3,6 months.
Change in urine β2-microglobulin.
Time frame: Baseline and 1,2,3,6 months.
Change in urine N-acetyl-β-D-glucosidase.
Time frame: Baseline and 1,2,3,6 months.
Change in urine neutrophil gelatinase-associated lipocalin.
Time frame: Baseline and 1,2,3,6 months.
Change in inflammation level.
Time frame: Baseline and 1,2,3,6 months.
Change in HbA1c.
Time frame: Baseline and 1,3,6 months.
Change in blood pressure control.
Time frame: Baseline and 1,2,3,6 months.
Change in blood lipids.
Time frame: Baseline and 1,3,6 months.
Life quality evaluation
Time frame: Baseline and 6 months.
Incidence of Treatment-Emergent Adverse Events
Time frame: half a year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No. The results belongs to the principal investigator and collaborators.
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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.
Zhiguang Zhou, MD/PhD principal investigator
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Jinshuibao Capsule in people with Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by Second Xiangya Hospital of Central South University 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 3 Jan 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in urine albumin creatine ratio (ACR). (time frame: Baseline and 1,2,3,6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2024.