| CTRI Number |
CTRI/2017/06/008870 [Registered on: 19/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine safety and effectiveness of Syrup Urophyll in patients of chronic kidney disease. |
|
Scientific Title of Study
|
A single arm, prospective study to determine safety and efficacy of Syrup Urophyll, 10 ml three times a day in patients diagnosed with chronic kidney disease and not on dialysis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patankar Suresh B |
| Designation |
Chairman |
| Affiliation |
Ace Hospital & Research Centre |
| Address |
S No- 32/2A, Erandwana, Gulawani maharaj road, Near Mehandale garage, Opp. hotel Abhishek, Pune -411004, India
Pune
MAHARASHTRA
411004
India |
| Phone |
02025455924 |
| Fax |
|
| Email |
sureshpatankarace@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharvari Rangnekar |
| Designation |
Co-ordinator |
| Affiliation |
Quest Clinical Services |
| Address |
ACE Hospital, S No- 32/2A, Erandwana, Gulawani maharaj road, Near Mehandale garage, Opp. hotel Abhishek, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9890229919 |
| Fax |
|
| Email |
dr.rangnekarsharvari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharvari Rangnekar |
| Designation |
Co-ordinator |
| Affiliation |
Quest Clinical Services |
| Address |
ACE Hospital, S No- 32/2A, Erandwana, Gulawani maharaj road, Near Mehandale garage, Opp. hotel Abhishek, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9890229919 |
| Fax |
|
| Email |
dr.rangnekarsharvari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure and premise of ACE Hospital, and Research Center, S.No. 32/2A, Erandwana, Gulawani Maharaj Road, Pune-411004 will be used. Thinq Pharma and CRO Ltd.Thinq house, Ground floor, G-1 Plot No A-30. Road No 10. MIDC, Wagle Estate, Thane (W)-400604 will sponsor this trial. |
|
|
Primary Sponsor
|
| Name |
Thinq Pharma CRO Limited |
| Address |
Thinq House, Ground Floor, G-1, Plot No. A-30, Road No. 10
M.I.D.C. Wagale Estate, Thane(West)400604 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Suresh Patankar |
ACE Hospital and Research Center |
Research Department, Room No-305 S No- 32/2A, Erandwana, Beside Mehendale garage, Pune - 411004
Pune
MAHARASHTRA |
02025455924
sureshpatankarace@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The AMAI Charitable Trusts ACE Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Kidney Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Syrup Urophyll |
Route: Oral
Dose: 10 ml thrice a day, diluted with water.
Duration: 3 months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Known case of chronic kidney disease aged between 18 and 70 years
2. Written informed consent
3. Serum Creatinine is at least 1.8 mg/dL at the time of screening
4. Blood pressure and blood sugar that is well controlled in the last one year
|
|
| ExclusionCriteria |
| Details |
1. Patients who has had episode(s) of dialysis in last 6 months
2. History of kidney transplant
3. Pregnant or breast-feeding woman
4. Nephrotic syndrome
5. Patients with uncontrolled diabetes, hypertension, gout or other illness
6. Participant of other clinical trial
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Creatinine |
2 and 3 months post enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sr. Urea, Hemoglobin, Quality of Life |
2 and 3 months post enrollment |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2016 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Investigational Product (IP) which is Syrup Urophyll is an approved and marketed adjuvant and an anti-oxidant product. It has sodium-copper-chlorophyllin as the main ingredient along with sorbitol, glycerin etc. It is approved and marketed as a food ingredient having fssai license number: 11513029000653.
The proposed study is to see the safety and efficacy of the IP in patients with compromised kidney functions.
All the patients enrolled in the study will get the IP. No medicine which his/her physician is giving/intends to give will be stopped. Thus, patients enrolled in the study will get the IP in addition to the standard of care,
otherwise the patient would have received. Known and old patients of CKD, who are already on medications, will also be enrolled if they are eligible and willing. Their regular medicines will not be stopped or altered due to their participation in the study. They also will be getting IP in addition to their routine standard of care. Though study period for enrolled patients is 3 months, IP will be given for 2 months only. Thus patients will be off the IP for last 30 days, though the standard of care or regular medicines will be continued throughout.
The IP may help reduce serum creatinine, increase the glomerular filtration rate (GFR) and thus benefit patients manage their CKD in a better manner. As participants will be given the standard of care which otherwise might have been given to them. Hence they are not deprived ethically of their right of standard of care.
|