Chronic Kidney FailurePhase 1/2NCT03142529
Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease
A Phase 1/2 study testing colon lotion in people with Chronic Kidney Failure and End-Stage Kidney Disease, run by Pang Peng at 1 site in China.
Trial summary
This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood dialysis therapy in adults. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Failure, End-Stage Kidney Disease
- What is being tested?
- colon lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2017to 15 Oct 2018
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.corresponding to diagnosis standards of CKD-5:eGFR≤15ml/min/1.73m2; 2. did not receive kidney replacement therapy; 3. no gastrointestinal diseases (including ulcerative colitis, irritable bowel syndrome, inflammation, cancer, infection, bleeding, etc.) in the past 1 year; 4.not associated with rectal-related disorders (hemorrhoids, anal fistula, rectal cancer, cancer, infection, bleeding, etc.); 5.Sign informed consent.
Who cannot join
- 1. having used antibiotics, hormones, immunosuppressive, probiotics and laxatives in past three months; 2. pregnant or lactating patients; 3.cannot cooperate or tolerate colonic dialysis treatment; 4.combined with active stage of malignant tumors, cardiovascular, respiratory system, decompensated liver cirrhosis or blood system diseases (including coagulation disorders, hematopoietic dysfunction, etc.) and other serious primary disease; 5. recent merger of patients with infectious diseases; 6.having known to be allergic to some drugs in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, 510006
Kun Bao, baokun@aliyun.com
About this study
Official title: Clinical Observation of Therapeutic Effects on Traditional Chinese Medicine Colon Dialysis Treating Non-dialysis End-Stage Kidney Disease
This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood dialysis therapy in adults. Half of participants will receive conventional integrated therapy on chronic renal failure (CRF), while the other half will receive integrated therapy on CRF and traditional Chinese medicine colonic dialysis.
Read the detailed description
Patients who would hospitalized in Nephrology of Guangdong Provincial Hospital of Traditional Chinese Medicine have chance to participate this study. All participates will be divided into two groups depending on their individual treatment interests and the baseline information will be balanced.
Integrated Therapy is routine symptomatic and supportive treatment for CRF,including reducing blood pressure and urine protein, improving anemia，regulating calcium and phosphorus metabolism and so on.The colon lotion used in colonic dialysis is a kind of hospital preparation. It consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The whole treatment lasts about 10 days,as long as a regular drill-and-fill procedure. Before and after the treatment, related body dimensions will be tested.
- Conditions
- Chronic Kidney Failure, End-Stage Kidney Disease
- Being tested
- colon lotion
- Keywords
- Non dialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colon lotionDrug
Also called YZ20071408
The colon lotion used in this clinic trial is a kind of hospital preparation. It is brown liquid,which consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The colon lotion is diluted from 30ml to 150ml each time and will be used once a day for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Therapy | No intervention | This arm is an control group,in which participants will receive conventional integrated therapy on CRF. |
| Integrated Therapy and colonic dialysis | Experimental | This arm is a treatment group,in which participants will receive integrated therapy on CRF and traditional Chinese medicine Colonic dialysis with traditional Chinese medicine colon lotion once a day. Receives: Drug: colon lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of glomerular filtration rate index
measuring the level of urea nitrogen，blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineβ2-microglobulin. calculating the creatinine clearance rate.
Measured: the first day before intervention and the eleventh day
Change of intestinal flora
measuring serum endotoxin and investigating the differences of intestinal flora between control group and experience group，as well as the differences between before colonic dialysis and after colonic dialysis.
Measured: the first day before intervention and the eleventh day
Secondary outcomes (3)
Change of serum electrolyte changes
measuring serum contents of sodium，potassium and phosphorus.
Measured: the first day before intervention and the eleventh day
Change of related inflammatory index
measuring hs-C reactive protein(hs-CRP),interleukin 1β(IL-1β)，IL-6，tumor necrosis factor α(TNF-α) in serum.
Measured: the first day before intervention and the eleventh day
Change of renal fibrosis index
measuring platelet derived growth factor (PDGF) secretion and serum transforming growth factor β(TGF-β).
Measured: the first day before intervention and the eleventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start15 May 2017
- Primary completion15 Aug 2018 (estimated)
- Study completion15 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pang Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Pang Peng, Jinan University Guangzhou
- Investigators
- Chen X Yin, Ph.D, Study chair, Jinan University GuangzhouBao Kun, Study director, Guangdong Provincial Hospital of Traditional Chinese MedicinePang Peng, Principal investigator, Jinan University Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142529
- Sponsor's protocol ID
- CRF-CD2017
- Status last verified
- May 2018
- First submitted
- 20 Apr 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Besides personal privacy information of the patients, all the other individual patient data（IPD）that treatment related will be shared with other researchers.After articles of this study publishing,researchers can obtain the information from the articles or sending e-mail to us.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Therapeutic Effects on Traditional Chinese Medicine Colon Dialysis Treating Non-dialysis End-Stage Kidney Disease
- ClinicalTrials.gov ID
- NCT03142529
- Acronym / sponsor ID
- CRF-CD2017
- Conditions
- Chronic Kidney Failure, End-Stage Kidney Disease
- Keywords
- Non dialysis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pang PengUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 Aug 2018 (estimated)
- Study completion
- 15 Oct 2018 (estimated)
- First posted
- 5 May 2017 (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.
This study evaluates the clinical efficacy and study the therapeutic mechanism of a kind of traditional Chinese medicine colonic dialysis on Chronic kidney disease (CKD) 5 without blood dialysis therapy in adults. Half of participants will receive conventional integrated therapy on chronic renal failure (CRF), while the other half will receive integrated therapy on CRF and traditional Chinese medicine colonic dialysis.
Detailed description
Patients who would hospitalized in Nephrology of Guangdong Provincial Hospital of Traditional Chinese Medicine have chance to participate this study. All participates will be divided into two groups depending on their individual treatment interests and the baseline information will be balanced.
Integrated Therapy is routine symptomatic and supportive treatment for CRF,including reducing blood pressure and urine protein, improving anemia，regulating calcium and phosphorus metabolism and so on.The colon lotion used in colonic dialysis is a kind of hospital preparation. It consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The whole treatment lasts about 10 days,as long as a regular drill-and-fill procedure. Before and after the treatment, related body dimensions will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Therapy | No intervention | –This arm is an control group,in which participants will receive conventional integrated therapy on CRF. |
| Integrated Therapy and colonic dialysis | Experimental | Drug: colon lotionThis arm is a treatment group,in which participants will receive integrated therapy on CRF and traditional Chinese medicine Colonic dialysis with traditional Chinese medicine colon lotion once a day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.corresponding to diagnosis standards of CKD-5:eGFR≤15ml/min/1.73m2; 2. did not receive kidney replacement therapy; 3. no gastrointestinal diseases (including ulcerative colitis, irritable bowel syndrome, inflammation, cancer, infection, bleeding, etc.) in the past 1 year; 4.not associated with rectal-related disorders (hemorrhoids, anal fistula, rectal cancer, cancer, infection, bleeding, etc.); 5.Sign informed consent.
Key exclusion criteria (1 listed)
- 1. having used antibiotics, hormones, immunosuppressive, probiotics and laxatives in past three months; 2. pregnant or lactating patients; 3.cannot cooperate or tolerate colonic dialysis treatment; 4.combined with active stage of malignant tumors, cardiovascular, respiratory system, decompensated liver cirrhosis or blood system diseases (including coagulation disorders, hematopoietic dysfunction, etc.) and other serious primary disease; 5. recent merger of patients with infectious diseases; 6.having known to be allergic to some drugs in the study.
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 |
|---|---|---|
| colon lotionAlso: YZ20071408The colon lotion used in this clinic trial is a kind of hospital preparation. It is brown liquid,which consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The colon lotion is diluted from 30ml to 150ml each time and will be used once a day for 10 days. | Drug | Integrated Therapy and colonic dialysis |
Primary outcome
Change of glomerular filtration rate index
Time frame: the first day before intervention and the eleventh day
measuring the level of urea nitrogen，blood urea nitrogen,serum creatinine, serum cystatin C, blood and urineβ2-microglobulin. calculating the creatinine clearance rate.
Change of intestinal flora
Time frame: the first day before intervention and the eleventh day
measuring serum endotoxin and investigating the differences of intestinal flora between control group and experience group，as well as the differences between before colonic dialysis and after colonic dialysis.
3 secondary outcomes
Change of serum electrolyte changes
Time frame: the first day before intervention and the eleventh day
Change of related inflammatory index
Time frame: the first day before intervention and the eleventh day
Change of renal fibrosis index
Time frame: the first day before intervention and the eleventh day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Yes. Besides personal privacy information of the patients, all the other individual patient data（IPD）that treatment related will be shared with other researchers.After articles of this study publishing,researchers can obtain the information from the articles or sending e-mail to us.
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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.
Chen X Yin, Ph.D study chair
Jinan University Guangzhou
Bao Kun study director
Guangdong Provincial Hospital of Traditional Chinese Medicine
Pang Peng principal investigator
Jinan University Guangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing colon lotion in people with Chronic Kidney Failure and End-Stage Kidney Disease, run by Pang Peng 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 1 inclusion and 1 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 30 May 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Pang Peng (01186-15099960366, pangpeng@stu2014.jnu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of glomerular filtration rate index (time frame: the first day before intervention and the eleventh day). The study lists 2 primary outcomes in all. 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 30 May 2018.