CTRI Number |
CTRI/2015/09/006181 [Registered on: 14/09/2015] Trial Registered Retrospectively |
Last Modified On: |
12/09/2015 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Probiotic |
Study Design |
Single Arm Study |
Public Title of Study
|
Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients |
Scientific Title of Study
|
A prospective ,Open Label,Observational Study to evaluate the Efficacy and Safety of Nitrophage Forte in Predialysis and Dialysis Patients |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIFTY/CR-0102,V-1.0 dated 12.Sep.2014 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
PrabhakaranP |
Designation |
Sales Manager |
Affiliation |
Mylin Biotech |
Address |
#291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079
Bangalore KARNATAKA 560 079 India |
Phone |
080-23284955 |
Fax |
080-23284955 |
Email |
p.prabhakaran@mylinbiotech.com |
|
Details of Contact Person Scientific Query
|
Name |
PrabhakaranP |
Designation |
Sales Manager |
Affiliation |
Mylin Biotech |
Address |
#291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079
Bangalore KARNATAKA 560 079 India |
Phone |
080-23284955 |
Fax |
080-23284955 |
Email |
p.prabhakaran@mylinbiotech.com |
|
Details of Contact Person Public Query
|
Name |
PrabhakaranP |
Designation |
Sales Manager |
Affiliation |
Mylin Biotech |
Address |
#291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079
Bangalore KARNATAKA 560 079 India |
Phone |
080-23284955 |
Fax |
080-23284955 |
Email |
p.prabhakaran@mylinbiotech.com |
|
Source of Monetary or Material Support
|
Mylin Biotech India Pvt Ltd,#291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079 |
|
Primary Sponsor
|
Name |
Mylin Biotech India Pvt Ltd |
Address |
#291,Commercial Complex,5th Main,5th Cross,KHB Colony,1st stage,Basaveshwaranagar,Bangalore,Karnataka,India-560079 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DrSanjay Srinivasa |
Sapthagiri Institute of Medical Sciences and Research Centre |
#15,Chikkasandra,Hesaragatta Main Road,Bangalore-560090 Bangalore KARNATAKA |
080-28393392 080-22188737 drsanjaysrinivas@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sapthagiri Institute of Medical Sceinces and Research Centre Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Chronic Kidney diseases , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NA |
NA |
Intervention |
Nitrophage Forte |
45 days
Twice daily before 30 minutes of food for patients who are on Dialysis Trice daily before 30 minutes of food for predialysis patients |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1. Patient aged ≥18 to 65 years of both female and male to be included
2.CKD patients with GFR <30 ml/minute
3.HD patients GFR<15ml/minute
4.Stage 3 and Stage 4 & 5 CKD patients
5.Patients who are on Dialysis for at least 3 months from the day of screening and Patients who are not doing well on Dialysis
6.Patient with the ability to provide written informed consent form
7.Patients willing to comply with the protocol requirements.
|
|
ExclusionCriteria |
Details |
1. Patients with known hypersensitivity to any of the components of the formulation
2. Patient with history of treatment with NitroPhage Forte
3. Active infectious conditions within the last 30days.
4. New York Heart Association (NYHA) Classification Category III and IV Cardiac Insufficiency, Ischaemic Heart Disease, Coronary Insufficiency or any other clinically significant cardiovascular disease.
5. Patients who have participated in any clinical trial in the past 1 month.
6. Autoimmune disease e.g. SLE/Vasculities
7. Diabetic foot infection patients
8. Pregnant or lactating women.
9. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
• Quality of life with improvement in nutritional status
• Improvement in Anti inflammatory markers such as TNF α and IL6
|
6 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Improvement in Lab Values such as BUN,Creatinine.
• Improvement in Uraemic Pruritus
|
6 weeks |
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
07/04/2015 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Detailed Description : Chronic kidney disease (CKD) is a global health issue that has a substantial impact on affected Individuals. The prognosis of dialysis patients is poor with 30 to 50 percent 5 year survival in nondiabetic patients and 25 percent in diabetic patients. Cardiovascular diseaseaccounts for approximately half of death of dialysis partients. Chonic inflammation, which is widely seen in long- term dialysis patients, is associated with malnutrition, atherosclerosis and an increased mortality risk. Inflammatory markers such as C-reactive protein (CRP), IL-6, Il-18 and TNF-alpha, are elevated in dialysis and can predict cardiovascular envent and all-cause mortality. Synbiotics ( combination of Probiotics and Prebiotics) are microorganisms given along with Oligosaccharides that have beneficial properties for the host. Three described benefits includes suppression of growth or epithelial binding/invasion by pathogenic bacteria, improvement of intestinal barrier function and modulation the immune systems. Several probiotics preparations induce protective cytokines, including IL-10, and suppresses proinflammmatory cytokines, such as TNF-alpha and IL-6. Intestinal microflora is deranged in hemodialysis (HD) patients and Predialysis Patients as an increase in aerobic bacteria such as E.coli and a decrease in anaerobic bacteria such as Bifidobacterium. One study reported that oral administration of Bifidobacterium longumm in gastroresistant capsules decreases the the pre-HD serum levels of homocysteine and indoxylsulfhate. Another small-scale study from Japan showed that synbiotics containing lactobacilli and can reduce serum level of p-Cresol in HD patients. High –serum p-cresyl sulfate and indoxyl sulfate levels were associated with overall mortality and cardiovascular disease in HD patients. |