| CTRI Number |
CTRI/2025/01/079656 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Clinical features and causes of Peripheral Neuropathy in Chronic Kidney Disease |
|
Scientific Title of Study
|
Study of Clinico-Etiological Profile Of Peripheral Neuropathy in Chronic Kidney Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Riya Dalal |
| Designation |
Juniour Resident under medicine |
| Affiliation |
DY Patil school of medicine Navi Mumbai |
| Address |
DY Patil hospital, department of Medicine 3rd floor, sector 5, Nerul, Navi Mumbai 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9322231922 |
| Fax |
|
| Email |
ru98malhotra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Patil |
| Designation |
Head of Department |
| Affiliation |
DY PATIL SCHOOL OF MEDICINE NAVI MUMBAI |
| Address |
DY PATIL HOSPITAL, DEPARTMENT OF MEDICINE 3RD FLOOR, SECTOR 5, NERUL, NAVI MUMBAI 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9322231922 |
| Fax |
|
| Email |
smita.patil@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riya Dalal |
| Designation |
Juniour Resident under medicine |
| Affiliation |
D Y Patil school of medicine, Navi Mumbai |
| Address |
DY Patil Hospital, Department of Medicine 3rd floor, sector 5, nerul 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9322231922 |
| Fax |
|
| Email |
ru98malhotra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil Medical College and Hospital, Nerul, Navi Mumbai, 400706, India |
|
|
Primary Sponsor
|
| Name |
Dr Riya Dalal |
| Address |
Junior Resident, department of General Medicine, Dr DY Patil medical College, Navi Mumbai- 400706 |
| Type of Sponsor |
Other [self] |
|
|
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 Riya Dalal |
Dr DY Patil Hospital |
OPD 1 (General Medicine OPD), ground floor, DR D Y Patil Hospital, Nerul, 400706
Thane
MAHARASHTRA |
9322231922
ru98malhotra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
!. All diagnosed CKD Patients (according to KDIGO guidelines)
2. Patients giving consent for study
3. patients of both genders above the age of 18years |
|
| ExclusionCriteria |
| Details |
1. patients with pre existing peripheral neuropathy before diagnosis of CKD or with other recognizable risk factors for peripheral neuropathy were excluded from study (e.g Diabetes mellitus, Alcoholism, Drug induced peripheral neuropathy, Hansens disease)
2. Patients on Peritoneal dialysis and kidney transplant recipients
3.Paitents on immunosuppressants and steroids
4. patients not giving consent
5. Patients less than 18 years of age |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Creatine levels
usg
sensory examination
motor examination |
base line 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Co relation of clinico-etiological profile of peripheral neuropathy in chronic kidney disese patients |
base line 1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According to article of pubmed central in the present study a variety of peripheral nerve disorders may be associated with chronic kidney disease. the polyneuropathy due to uremic toxins is distal, motor and sensory. The nature of the uremic toxin and underlying cause in unknown. This study deals with with various various clinical aspects and probable causes of peripheral neuropathy in chronic kidney disease patients |