NCT03009864

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
632

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

January 2, 2017

Last Update Submit

January 3, 2017

Conditions

Diabetic Kidney Disease

Keywords

Diabetic Kidney DiseaseTCMRCT

Outcome Measures

Primary Outcomes (1)

  • changes of albumin-to-creatinine ration

    0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks

Secondary Outcomes (4)

  • number of participants of diabetic kidney disease in macroalbuminuria stage

    0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks

  • number of participants whose microalbuminuria excretion rate < 20ug/min

    0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks

  • change of GFR

    0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks

  • the rate of doubling the baseline with serum creatinine value

    0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks

Study Arms (2)

Tangshen Prescription

EXPERIMENTAL

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 PrescriptionDrug: Placebos

Placebo

PLACEBO COMPARATOR

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 PrescriptionDrug: Placebos

Interventions

Tangshen PrescriptionDRUG

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

PlaceboTangshen Prescription
PlacebosDRUG

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.

PlaceboTangshen Prescription

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

  • 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.

    PMID: 31864393DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Fengmei Lian, PHD

CONTACT

0086-010-88001402lfm565@sohu.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 4, 2017

Study Start

January 1, 2017

Primary Completion

September 1, 2019

Study Completion

May 1, 2020

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

CN(1)