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CTRI Number  CTRI/2018/05/013934 [Registered on: 17/05/2018] Trial Registered Retrospectively
Last Modified On: 09/05/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Efficacy of Herbometallic Ayurvedic Compounds used in Chronic Kidney diseases  
Scientific Title of Study   Retrospective observational study to evaluate therapeutic efficacy of Herbometallic Ayur-vedic compounds in the management of patients with chronic kidney disease (CKD) with respect to improvement in renal functions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh Bendale  
Designation  Chairman Rasayu Cancer Clinic  
Affiliation  Rasayu Cancer Clinic, Pune. 
Address  Rasayu Cancer Clinic, B1, Amrutkumbh, Navi Peth, Pune.
B-1, Amrutkumbh, Laxmipark Soc., Navi peth, Pune 411 030.
Pune
MAHARASHTRA
411030
India 
Phone  020-24537149  
Fax  020-24537149  
Email  dr.bendale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poonam Birari 
Designation  Physician 
Affiliation  Rasayu Cancer Clinic, Pune. 
Address  Rasayu Cancer Clinic, B1, Amrutkumbh, Navi Peth, Pune.
B-1, Amrutkumbh, Laxmipark Soc., Navi peth, Pune 411 030.
Pune
MAHARASHTRA
411030
India 
Phone  020-24537149  
Fax  020-24537149  
Email  poonam.birari84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Poonam Birari 
Designation  Physician 
Affiliation  Rasayu Cancer Clinic, Pune. 
Address  Rasayu Cancer Clinic, B1, Amrutkumbh, Navi Peth, Pune.
B-1, Amrutkumbh, Laxmipark Soc., Navi peth, Pune 411 030.
Pune
MAHARASHTRA
411030
India 
Phone  020-24537149  
Fax  020-24537149  
Email  poonam.birari84@gmail.com  
 
Source of Monetary or Material Support  
Rasayani Cancer Clinics, Pune. 
 
Primary Sponsor  
Name  Rasayani Cancer Clinics Pune 
Address  B-1 Amrutkumbh Laxmipark Soc Navi peth Opp Sargam Hotel Pune 411 030 Maharashtra India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogesh Bendale   Ayurveda Clinic Amrutkumbh Navi Peth Pune.  B-1 Amrutkumbh Laxmipark Soc Navi peth Opp Sargam Hotel Pune 411 030 Maharashtra India
Pune
MAHARASHTRA 
020-24537149
020-24532525
dr.bendale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Rasayu Cancer Clinic pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Kideny Diseases(CKD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Herbometallic Ayurvedic Compounds   Retrospective observational study to evaluate therapeutic efficacy in the management of patients with chronic kidney disease (CKD) with respect to improvement in renal functions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Primary diagnosis of Chronic Renal Failure with Serum creatinine >1.5 mg/dL
Elevated Cystantin C level
Patients taking or has taken Ayurved therapy for treatment of Chronic Renal Failure
Patients taking or has taken Ayurved therapies for a minimum period of 3 months
 
 
ExclusionCriteria 
Details  1. Patients taking or has taken injection of erythropoietin. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the changes in parameter pf renal function in patient of CKD undergoing biologically derived herbometallic Ayurveda therapies.   Data of each patient for a follow up of minimum three months upto two years will be used. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluates the benefits of "Ayurveda" therapies as clinically observed and experienced by patient with chronic renal failure undergoing these therapies.












 
Data of each patient for a follow up of minimum three months upto two years will be used.  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   11/04/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Chronic Renal disease is such a condition for which the modern therapeutics presently has certain limitations related to therapeutic options.Therefore this status is creating unmet clinical needs in such patients. In India the prevalence of CKD was observed to be 17.2% with ~6% have CKD stage 3 or worse. World-wide there is a rising incidence of chronic kidney disease that is likely to pose major problems for both healthcare and the economy in future years.

In” Ayurveda” several patients with chronic kidney diseases take treatment. But there lacks a systematic studies to determine the various benefits expected by the patients and the spectrum of benefits received by them. The present study is a retrospective observational study to evaluate the changes in parameters of renal functions and to evaluate the benefits of “Ayurveda” therapies as clinically observed and experienced by patients with Chronic Renal Failure undergoing Ayurvedic herbometallic formulations containing biologically derived metals and minerals.

In present study we will review retrospective medical chart of CKD patients.In the process there is no riskas identity of subjects is not disclosed.However the investigators will ensure maintaining patients confidentiality by using only patients code in study documents.

Data of each patient with a follow-up of minimum 3 months up to two years will be used and it will be collected from the available 50 case papers and source documents of patients fulfilling the eligibility criteria. After wards patient’s blood parameters will be measured. 

 
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