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
|
|
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
|
|
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. |