| CTRI Number |
CTRI/2012/09/002947 [Registered on: 03/09/2012] Trial Registered Retrospectively |
| Last Modified On: |
10/10/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy and the safety profile of Rhubarb and alpha-Keto amino acid supplementation on patients of Chronic kidney disease. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy and safety profile of Rhubarb and alpha-Keto analogue of amino acid supplementation on patients of Chronic Kidney Disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 15/11/2011 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr IRFAN AHMAD KHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
J.N. MEDICAL COLLEGE, A.M.U. |
| Address |
DEPARTMENT OF PHARMACOLOGY, J.N.
MEDICAL COLLEGE, A.M.U., ALIGARH,U.P.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997448504 |
| Fax |
|
| Email |
irfan1308@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHAMMAD NASIRUDDIN |
| Designation |
Assistant Professor |
| Affiliation |
J.N. MEDICAL COLLEGE, A.M.U. |
| Address |
DEPARTMENT OF PHARMACOLOGY, J.N.
MEDICAL COLLEGE, A.M.U., ALIGARH,U.P.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412596898 |
| Fax |
|
| Email |
naseer_bettiah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr IRFAN AHMAD KHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
J.N. MEDICAL COLLEGE, A.M.U. |
| Address |
DEPARTMENT OF PHARMACOLOGY, J.N.
MEDICAL COLLEGE, A.M.U., ALIGARH,U.P.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997448504 |
| Fax |
|
| Email |
irfan1308@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Pharmacology And Department Of Medicine, J.N. MEDICAL COLLEGE, A.M.U., ALIGARH, U.P. |
|
|
Primary Sponsor
|
| Name |
Department Of Pharmacology And Department Of Medicine |
| Address |
Department Of Pharmacology And Department Of Medicine,
J.N.MEDICAL COLLEGE, A.M.U., ALIGARH, U.P. |
| Type of Sponsor |
Government medical college |
|
|
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 IRFAN AHMAD KHAN |
Department Of Pharmacology And Department Of Medicine |
J.N.MEDICAL COLLEGE, A.M.U., ALIGARH, U.P.
Aligarh
UTTAR PRADESH |
9997448504
irfan1308@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, J.N. MEDICAL COLLEGE, A.M.U., ALIGARH, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic kidney disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
alpha-Keto analogue of amino acid + conservative management |
360 mg orally OD for 3 months + conservative management for 3 months |
| Comparator Agent |
conservative management |
orally/iv/im for 3 months |
| Intervention |
Rhubarb + conservative management |
350mg orally BD for 3 months + conservative management for 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
•Chronic kidney disease of different etiology, before ESRD.
•Patient not on dialysis.
|
|
| ExclusionCriteria |
| Details |
•Pregnancy
•Acute infection
•Psychotic patient
•Critically ill patient
•HIV/HBsAg/Anti-HCV and immunocompromised patient.
•Severe Renal pathology such as malignancy
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Haemogram
2.Urine- Routine & Microscopic
3.Blood Glucose
4.Total Urine Protein(TUP)
5.Blood Urea
6.Serum Creatinine
7.Urine Creatinine
|
Pre-dose and after 1st 2nd 3rd month after starting dosing |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.USG-Both kidneys
2.Chest X-ray( PA VIEW)
|
Pre-dose and after 3 month post-dose. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2012 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is designed as open-label, randomised, parallel group, study in patients with Chronic Kidney Disease who are not on dialysis. Efficacy and the safety profile of alpha Keto-amino acid and Rhubarb supplementation on patients of Chronic kidney disease is planned to be investigated. Around one hundred subjects will be enrolled into the study in three groups. The subjects will be randomised to receive either conservative management or conservative management + Rhubarb or conservative management + alpha-Keto analogue of essential amino acid. All subjects will be followed up 1,2,3 months to assess efficacy and the safety profile. |