| CTRI Number |
CTRI/2019/01/017070 [Registered on: 14/01/2019] Trial Registered Prospectively |
| Last Modified On: |
01/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to understand the effect and safety of new treatment on patients with kidney problem |
|
Scientific Title of Study
|
A prospective, double blind,randomized, placebo controlled Interventional study to evaluate the safety and efficacy of Enzobiotics ( Synbiotics and Proteolytic Enzymes )in pre dialysis kidney disease patients
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ilangovan Veerappan |
| Designation |
Director |
| Affiliation |
K G Hospital |
| Address |
K G Hospital
No 5 Government Arts College Road,
1st Floor
Opposite Court, Gopalapuram, Coimbatore.
Coimbatore
TAMIL NADU
641018
India |
| Phone |
|
| Fax |
|
| Email |
ilangovanv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Prabhakaran |
| Designation |
General Manager Sales and Marketing |
| Affiliation |
Mylin Biotech India Pvt Ltd |
| Address |
Mylin Biotech India Pvt Ltd
No 40/11 1
2nd floor Govindraj Nagar Magadi Road
Bangalore
KARNATAKA
560040
India |
| Phone |
9008641199 |
| Fax |
|
| Email |
p.prabhakaran@mylinbiotech.com |
|
Details of Contact Person
Public Query
|
| Name |
P Prabhakaran |
| Designation |
General Manager Sales and Marketing |
| Affiliation |
Mylin Biotech India Pvt Ltd |
| Address |
Mylin Biotech India Pvt Ltd
No 40/11 1
2nd floor Govindraj Nagar Magadi Road
Bangalore
KARNATAKA
560040
India |
| Phone |
9008641199 |
| Fax |
|
| Email |
p.prabhakaran@mylinbiotech.com |
|
|
Source of Monetary or Material Support
|
| Myline Biotech India Pvt Ltd
40/11 1
2nd Floor Govindraj nagar
Magadi Road
Bangalore 560040
Karnataka |
|
|
Primary Sponsor
|
| Name |
Myline Biotech India Pvt Ltd |
| Address |
No 40/11 1
2nd floor Govindraj Nagar Magadi Road Bangalore 560040. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chakko Korula Jacob |
Bangalore Baptist Hospital |
Ground Floor No 6
Bellary Road
Hebbal
Bangalore
Bangalore
KARNATAKA |
9535236019
chakkokorulajacob@gmail.com |
| Dr Sanjay Srinivas |
Center For Kidney & Diabetes |
N0 357/B Ground floor Room No 1 Bangalore Bellary Raoad , Near HDFC bank Yelahanka Town Bangalore 560064
Bangalore
KARNATAKA |
9901996755
drsanjay.nephro@gmail.com |
| Dr Ilangovan Veerappan |
K G Hospital |
No 5 1st Floor,
Government Arts College Road Opposite Court
Gopalapuram Coimbatore
Coimbatore
TAMIL NADU |
8754025648
ilangovanv@gmail.com |
| Dr Anita Saxena |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
1st Floor Rae Bareli Road
Haibat Mau Mawaiya
Lucknow
Uttar Pradesh 226014
Lucknow
UTTAR PRADESH |
9453019812
anitimmy@yahoo.com |
| Dr Amol Ramesh Mahaldar |
Vision Multispeciality Hospital |
Duler, Mapusa Goa 403507
Department of Nephrology
OPD room No 305 3rd floor
North Goa
GOA |
9404756959
dramolmahaldar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Bangalore Baptist Institutional Review Board |
Approved |
| KG Hospital and Postgraduate Medical Institute |
Approved |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Approved |
| Sree Venkateshwara Hospital Ehics commitee |
Approved |
| Sree Venkateshwara Hospital Ehics commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Enzobiotics |
550 mg capsule
Oral Route
1 capsule to be taken 3 times daily 5 minutes before food for 3 months |
| Comparator Agent |
Placebo |
Maltodextrin 550mg
Oral route
1 capsule to be taken 3 times daily 5 minutes before food for 3 months
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects aged between 18 and 70yrs
2 Stage 3 4 and 5
3 Patients wanting to delay dialysis.
4 Willing to come for regular follow up visits
5 Able to give written informed consent
|
|
| ExclusionCriteria |
| Details |
1 Pregnant and lactation.
2 Autoimmune disease e g SLE/Vasculities
3 Subjects with hepatic impairement (SGOT or SGPT levels more than 3 times the upper limit)
4 Diabetic foot infection patients
5 Subjects with uncontrolled cardiovascular events.
6 Patients who have been prescribed Synbiotics and Enzymes.
7Subjects with any other severe systemic illness and in the opinion of the investigator would be non compliant with the visit schedule or study procedures.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Assess the Safety and Efficacy of Enzobiotics in CKD Stage 3 4 and Stage 5 Patients
2 Improvement in eGFR calculated by CKD EPI formula
3 Change in P Cresols and Indoxylsulfhate Protein bound Uremic toxins levels & Quality of life SF 36 regular for CKD patients and SGA scoring
|
0 45 and 90 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change in BUN Creatinine Hemoglobin Phosphorous Potassium Sodium Albumin serum Hs Crp Urea Total Protein Tryglycerides Total cholesterol HDL LDL |
0 45 and 90 days |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a prospective, double blind, randomized, placebo controlled Interventional study to evaluate the safety and efficacy of Enzobiotics in pre dialysis kidney disease patients. The participating group is between the age of 18 to 70 years. A total of 80 patients will be recruited in the study both male and female. Patients with chronic kidney disease with stage 3,4 and 5 are included who are not undergoing dialysis. All patients randomized either to active or placebo will have to take 3 capsules daily for 90 days. Primary Study assessment is through the improvement in eGFR, P Cresols, Indoxysulfhate, Protein bound Uremic toxins levels, Quality of life SF-36 (regular for CKD patients) and SGA scoring from baseline to day 90. Secondary study assessment is to understand Change in BUN, Creatinine, Hemoglobin, Phosphorous, Potassium, Sodium , Albumin serum, Hs Crp, Urea , Total Protein, Tryglycerides Total cholesterol, HDL, LDL, body weight, mid arm circumference, Waist : Hip ratio from baseline to day 90.
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