Diabetic Nephropathy Type 2Early Phase 1NCT03681249
the Integrated Traditional Chinese and Western Medicine Treat Middle Stage DKD
A Early Phase 1 study testing ShenqiDihuang Decoction in people with Diabetic Nephropathy Type 2, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy Type 2
- What is being tested?
- ShenqiDihuang Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2018to 31 Dec 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify the diagnosis of type 2 diabetes;
- It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV;
- eGFR ≥ 30 ml / min / 1.73 m2;
- Age 18-75 years old, gender ＆ethnicity are not limited;
- glycated hemoglobin ≤ 10%;
- Blood pressure is controlled below 130/80mmHg
Who cannot join
- Combine other ACEI and ARB application indications other than hypertension;
- Combine severe primary diseases related to heart, brain, liver and hematopoietic system;
- Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month;
- Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities;
- Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents;
- Patients with acute renal failure, combined with urinary tract infection, menstrual period, intense exercise, cold and other stress states;
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- pregnant or lactating women;
- Patients who accepted other clinical trial studies on going ;
- Patients who combined with serious diseases and dysfunctions in other organs.
Trial locations and contacts
1 site in 1 country.
China1 site
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Multicenter Clinical Study on the Treatment of Middle Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine
Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.
Read the detailed description
The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital of Integrated Traditional Chinese Medicine and Western Medicine, China.
- Conditions
- Diabetic Nephropathy Type 2
- Being tested
- ShenqiDihuang Decoction, ShenqiDihuang Decoction placebo
- Keywords
- Diabetic Kidney Disease，Traditional Chinese medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShenqiDihuang DecoctionDrug
Also called nseng, Astragalus, Rehmannia and other TCMs Decoction
ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks
ShenqiDihuang Decoction placeboDrug
Also called Ginseng, Astragalus, Rehmannia Decoction placebo
traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| ShenqiDihuang Decoction | Experimental | ShenqiDihuang Decoction 150ml by mouth, twice a day for 24 weeks Receives: Drug: ShenqiDihuang Decoction |
| ShenqiDihuang Decoction placebo | Placebo comparator | ShenqiDihuang Decoction placebo 150ml by mouth, twice a day for 24 weeks Receives: Drug: ShenqiDihuang Decoction placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24H urine total protein
t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start2 Nov 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yueyi Deng, PhD, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681249
- Sponsor's protocol ID
- 17401970500-b
- Status last verified
- May 2022
- First submitted
- 20 Sep 2018
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study on the Treatment of Middle Stage Diabetic Kidney Disease With Integrated Traditional Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT03681249
- Acronym / sponsor ID
- 17401970500-b
- Conditions
- Diabetic Nephropathy Type 2
- Keywords
- Diabetic Kidney Disease，Traditional Chinese medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Sep 2018 (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.
Efficacy and Safety of treatment with Traditional Chinese Medicine ShenqiDihuang Decoctions in Patients with middle stage of Diabetic Kidney Disease.
Detailed description
The study is a multi-center, randomized, double-blind, placebo-controlled trial. It is performed in Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, and Shanghai Baoshan District Hospital of Integrated Traditional Chinese Medicine and Western Medicine, China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShenqiDihuang Decoction | Experimental | Drug: ShenqiDihuang DecoctionShenqiDihuang Decoction 150ml by mouth, twice a day for 24 weeks |
| ShenqiDihuang Decoction placebo | Placebo comparator | Drug: ShenqiDihuang Decoction placeboShenqiDihuang Decoction placebo 150ml by mouth, twice a day for 24 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Identify the diagnosis of type 2 diabetes;
- It meets the medical history of diabetic kidney disease, according to the Mogensen diagnostic staging standard DKD IV;
- eGFR ≥ 30 ml / min / 1.73 m2;
- Age 18-75 years old, gender ＆ethnicity are not limited;
- glycated hemoglobin ≤ 10%;
Key exclusion criteria (9 listed)
- Combine other ACEI and ARB application indications other than hypertension;
- Combine severe primary diseases related to heart, brain, liver and hematopoietic system;
- Patients who have acute metabolic disorders such as diabetic ketoacidosis occur in the past month;
- Patients who HBV serological indicators except HbsAb are positive and persistent liver function test transaminase abnormalities;
- Patients with malignant tumors or history of malignant tumors, history of HIV infection, history of psychosis, acute central nervous system diseases, severe gastrointestinal diseases, and banned use of immunosuppressive agents;
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 |
|---|---|---|
| ShenqiDihuang DecoctionAlso: nseng, Astragalus, Rehmannia and other TCMs DecoctionShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks | Drug | ShenqiDihuang Decoction |
| ShenqiDihuang Decoction placeboAlso: Ginseng, Astragalus, Rehmannia Decoction placebotraditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks | Drug | ShenqiDihuang Decoction placebo |
Primary outcome
24H urine total protein
Time frame: 24 weeks
t24-hour urine total protein quantitation in stage Ⅳ diabetes kidney disease patients
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 6 May 2022.
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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.
Yueyi Deng, PhD principal investigator
Shanghai University of Traditional Chinese Medicine
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 ShenqiDihuang Decoction in people with Diabetic Nephropathy Type 2, run by Shanghai University of Traditional Chinese Medicine 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 6 inclusion and 9 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 6 May 2022. 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?
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?
24H urine total protein (time frame: 24 weeks). 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 6 May 2022.