Back to resultsThe Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
Primary Purpose
Diabetic Kidney Disease
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Tangshen Prescription
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring Diabetic Kidney Disease, TCM, RCT
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of type 2 diabetic Kidney Disease in early stage;
- Aged 30-70;
- Signed the informed consent.
Exclusion Criteria:
- Non-diabetic renal disease, such as gout, essential hypertension, tumors, and chronic kidney disease which may cause proteinuria or microalbuminuria.
- Cardiovascular disease、hepatopathy、kidney disease and hematopoietic disease et al, the serum transaminase was two times larger than the normal valuet、serum creatinine concentration greater than the upper limit of normal value and psychiatric disease.
- Women with Pregnancy or prepare for pregnancy or lactating.
- Degree of renal failure have developed to the stage of hypoxemia and uremia.
- Patients participate in other clinical researchers within a month.
- Patients have been treated with the angiotensin receptor blocker (ARB) drugs to treat diabetic kidney disease except for losartan within a month.
- Patients have been treated with angiotensin-converting enzyme inhibitors (ACEI) drugs to treat diabetic kidney disease within a month.
- Systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg.
- Patients with diabetic ketosis, ketoacidosis and severe infections within a month.
- Patients addicting alcohol, psychoactive substances within 5 years.
- According to the researcher's judgment, there are other diseases or situations that can reduce the possibility of entering the group or complicate the group, such as frequent changes in the working environment and unstable living environment.
Sites / Locations
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tangshen Prescription
Placebo
Arm Description
The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.
Outcomes
Primary Outcome Measures
changes of albumin-to-creatinine ration
Secondary Outcome Measures
number of participants of diabetic kidney disease in macroalbuminuria stage
number of participants whose microalbuminuria excretion rate < 20ug/min
change of GFR
the rate of doubling the baseline with serum creatinine value
Full Information
NCT ID
NCT03009864
First Posted
January 2, 2017
Last Updated
January 3, 2017
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Zhengzhou City Hospital of Traditional Chinese Medicine, Shijiazhuang City Hospital of Traditional Chinese Medicine, Baoding City Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Changchun Hospital of Traditional Chinese Medicine, Xingtai City Hospital of Traditional Chinese Medicine, Medicine Zibo Wanjie Tumor Hospital, Zouping Country Hospital of Traditional Chinese Medicine, She Country Hospital of Traditional Chinese Medicine, Beijing Hospital of TCM, Baishi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03009864
Brief Title
The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
Official Title
The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Zhengzhou City Hospital of Traditional Chinese Medicine, Shijiazhuang City Hospital of Traditional Chinese Medicine, Baoding City Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Changchun Hospital of Traditional Chinese Medicine, Xingtai City Hospital of Traditional Chinese Medicine, Medicine Zibo Wanjie Tumor Hospital, Zouping Country Hospital of Traditional Chinese Medicine, She Country Hospital of Traditional Chinese Medicine, Beijing Hospital of TCM, Baishi Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200mg/min) to evaluate the therapeutic effect of tang shen prescription. 632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The subjects will be randomized to treatment with either tang shen prescription or placebo.
Detailed Description
This study is a randomized, double-blinded, placebo-controlled clinical trial on type 2 diabetic Kidney Disease in early stage ( microalbuminuria excretion rate = 20-200ug/min) to evaluate the therapeutic effect of tang shen prescription.632 participants will be recruited for the study, all of whom had type 2 diabetes, serum creatinine concentrations is normal, and no evidence of non-diabetic renal diseases. The study will last for 24 weeks. Subjects will be randomly divided into two groups, either tang shen prescription or placebo，and both of them would be performed on a basic treatment which includes diabetes education, diabetic diet, rational control of blood glucose, and losartan at 50 mg daily, study group take tang wang prescription. Measurements of microalbuminuria excretion rate, albumin-to-creatinine ration, glomerular filtration rate (GFR), serum creatinine concentrations will be tested monthly, and quantity of 24h urinary protein per three months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
Diabetic Kidney Disease, TCM, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
632 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tangshen Prescription
Arm Type
Experimental
Arm Description
The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo corresponding to each dose of Tangshen Prescription
, every bag weighs 4.87g, take it one bag each time, two times a day.
Intervention Type
Drug
Intervention Name(s)
Tangshen Prescription
Intervention Description
The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.
Primary Outcome Measure Information:
Title
changes of albumin-to-creatinine ration
Time Frame
0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Secondary Outcome Measure Information:
Title
number of participants of diabetic kidney disease in macroalbuminuria stage
Time Frame
0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks
Title
number of participants whose microalbuminuria excretion rate < 20ug/min
Time Frame
0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Title
change of GFR
Time Frame
0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Title
the rate of doubling the baseline with serum creatinine value
Time Frame
0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of type 2 diabetic Kidney Disease in early stage;
Aged 30-70;
Signed the informed consent.
Exclusion Criteria:
Non-diabetic renal disease, such as gout, essential hypertension, tumors, and chronic kidney disease which may cause proteinuria or microalbuminuria.
Cardiovascular disease、hepatopathy、kidney disease and hematopoietic disease et al, the serum transaminase was two times larger than the normal valuet、serum creatinine concentration greater than the upper limit of normal value and psychiatric disease.
Women with Pregnancy or prepare for pregnancy or lactating.
Degree of renal failure have developed to the stage of hypoxemia and uremia.
Patients participate in other clinical researchers within a month.
Patients have been treated with the angiotensin receptor blocker (ARB) drugs to treat diabetic kidney disease except for losartan within a month.
Patients have been treated with angiotensin-converting enzyme inhibitors (ACEI) drugs to treat diabetic kidney disease within a month.
Systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg.
Patients with diabetic ketosis, ketoacidosis and severe infections within a month.
Patients addicting alcohol, psychoactive substances within 5 years.
According to the researcher's judgment, there are other diseases or situations that can reduce the possibility of entering the group or complicate the group, such as frequent changes in the working environment and unstable living environment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fengmei Lian, PHD
Phone
0086-010-88001402
Email
lfm565@sohu.com
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengmei Lian, PHD
Phone
0086-010-88001402
Email
lfm565@sohu.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31864393
Citation
Jin D, Huang WJ, Meng X, Yang F, Bao Q, Zhang MZ, Yang YN, Ni Q, Lian FM, Tong XL. Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial. Trials. 2019 Dec 21;20(1):756. doi: 10.1186/s13063-019-3821-6.
Results Reference
derived
Learn more about this trial
The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
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