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The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage

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ClinicalTrials.gov Identifier: NCT03009864
Recruitment Status : Not yet recruiting
First Posted : January 4, 2017
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
Anhui Provincial Hospital 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
Information provided by (Responsible Party):
Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Drug: Tangshen Prescription Drug: Placebos Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
Study Start Date : January 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tangshen Prescription
The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
Drug: Tangshen Prescription
The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.

Drug: Placebos
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.

Placebo Comparator: Placebo

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.

Drug: Tangshen Prescription
The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.

Drug: Placebos
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 Measures :
  1. changes of albumin-to-creatinine ration [ Time Frame: 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks ]

Secondary Outcome Measures :
  1. number of participants of diabetic kidney disease in macroalbuminuria stage [ Time Frame: 0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks ]
  2. number of participants whose microalbuminuria excretion rate < 20ug/min [ Time Frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks ]
  3. change of GFR [ Time Frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks ]
  4. the rate of doubling the baseline with serum creatinine value [ Time Frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of type 2 diabetic Kidney Disease in early stage;
  2. Aged 30-70;
  3. Signed the informed consent.

Exclusion Criteria:

  1. Non-diabetic renal disease, such as gout, essential hypertension, tumors, and chronic kidney disease which may cause proteinuria or microalbuminuria.
  2. 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.
  3. Women with Pregnancy or prepare for pregnancy or lactating.
  4. Degree of renal failure have developed to the stage of hypoxemia and uremia.
  5. Patients participate in other clinical researchers within a month.
  6. Patients have been treated with the angiotensin receptor blocker (ARB) drugs to treat diabetic kidney disease except for losartan within a month.
  7. Patients have been treated with angiotensin-converting enzyme inhibitors (ACEI) drugs to treat diabetic kidney disease within a month.
  8. Systolic blood pressure over 160mmHg or diastolic blood pressure over 100mmHg.
  9. Patients with diabetic ketosis, ketoacidosis and severe infections within a month.
  10. Patients addicting alcohol, psychoactive substances within 5 years.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03009864


Contacts
Contact: Fengmei Lian, PHD 0086-010-88001402 lfm565@sohu.com

Locations
China, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100053
Contact: Fengmei Lian, PHD    0086-010-88001402    lfm565@sohu.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Anhui Provincial Hospital 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

Responsible Party: Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03009864     History of Changes
Other Study ID Numbers: 201507001-11Tangshen
First Posted: January 4, 2017    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Diabetic Kidney Disease
TCM
RCT

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases