Diabetic Kidney DiseaseEarly Phase 1NCT03009864
The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
A Early Phase 1 study testing Tangshen Prescription in people with Diabetic Kidney Disease, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Tangshen Prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 632 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to May 2020
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetic Kidney Disease in early stage;
- Aged 30-70;
- Signed the informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
Fengmei Lian, PHD, 0086-010-88001402, lfm565@sohu.com
About this study
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.
Read the 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.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Tangshen Prescription, Placebos
- Keywords
- Diabetic Kidney Disease, TCM, RCT
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tangshen Prescription; Drug: 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. Receives: Drug: Tangshen Prescription; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of albumin-to-creatinine ration
Measured: 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Secondary outcomes (4)
number of participants of diabetic kidney disease in macroalbuminuria stage
Measured: 0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks
number of participants whose microalbuminuria excretion rate < 20ug/min
Measured: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
change of GFR
Measured: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
the rate of doubling the baseline with serum creatinine value
Measured: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionSep 2019 (estimated)
- 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 Diabetic Kidney DiseaseStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Lian-fengmei, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009864
- Sponsor's protocol ID
- 201507001-11Tangshen
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31864393
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-Center Clinical Study of Tang Shen Prescription on Type 2 Diabetic Kidney Disease in Early Stage
- ClinicalTrials.gov ID
- NCT03009864
- Acronym / sponsor ID
- 201507001-11Tangshen
- Conditions
- Diabetic Kidney Disease
- Keywords
- Diabetic Kidney Disease, TCM, RCT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- 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
- Study start
- Jan 2017
- Primary completion
- Sep 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 4 Jan 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tangshen Prescription | Experimental | Drug: Tangshen Prescription, Drug: PlacebosThe prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day. |
| Placebo | Placebo comparator | Drug: Tangshen Prescription, Drug: PlacebosTreatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of type 2 diabetic Kidney Disease in early stage;
- Aged 30-70;
- Signed the informed consent.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Tangshen PrescriptionThe prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day. | Drug | Placebo, Tangshen Prescription |
| PlacebosTreatment 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 | Placebo, Tangshen Prescription |
Primary outcome
changes of albumin-to-creatinine ration
Time frame: 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
4 secondary outcomes
number of participants of diabetic kidney disease in macroalbuminuria stage
Time frame: 0 week, 4 weeks,8 weeks, 12weeks,16weeks, 20weeks, 24weeks
number of participants whose microalbuminuria excretion rate < 20ug/min
Time frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
change of GFR
Time frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
the rate of doubling the baseline with serum creatinine value
Time frame: 0 week, 4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 31864393Jin 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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tangshen Prescription in people with Diabetic Kidney Disease, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences 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 3 inclusion and 11 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 Jan 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Fengmei Lian, PHD (0086-010-88001402, lfm565@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of albumin-to-creatinine ration (time frame: 0 week,4 weeks, 8 weeks,12weeks,16weeks, 20weeks, 24weeks). 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 NCT03009864, 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 Jan 2017.