| CTRI Number |
CTRI/2024/07/070853 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Study of effect of individualized homoeopathic medicine on quality of life in patients on hemo-dialysis in end stage kidney disease |
|
Scientific Title of Study
|
Evaluation of effectiveness of individualized homoeopathic medicine on quality of life in patients on hemo-dialysis in end stage kidney disease: a placebo control study. |
| 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 Anil Vishnu Paradkar |
| Designation |
PhD Scholar |
| Affiliation |
YMT homoeopathic medical college and PG institute |
| Address |
Sector 4 kharghar navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987716110 |
| Fax |
|
| Email |
dranilvp@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sachin Yashwant Chokkakar |
| Designation |
Associate Professor |
| Affiliation |
YMT homoeopathic medical college and PG institute |
| Address |
Sector 4 kharghar navi mumbai Maharashtra India 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987716110 |
| Fax |
|
| Email |
ymthmc01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Vishnu Paradkar |
| Designation |
PhD Scholar |
| Affiliation |
YMT homoeopathic medical college and PG institute |
| Address |
Sector 4 kharghar navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987716110 |
| Fax |
|
| Email |
dranilvp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| YMT homoeopathic medical college and PG institute, Kharghar, Navi Mumbai Maharashtra, India 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Anil Vishnu Paradkar |
| Address |
YMT homoeopathic medical college and PG institute, Kharghar, Navi Mumbai Maharashtra, India 410210 |
| 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 Anil Vishnu Paradkar |
Dialysis Unit, YMT Homoeopathic Medical Hospital |
Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
9987716110
dranilvp@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee YMT Homoeopathic Medical College and PG Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
One Group is given Individualized Homoeopathic Medicine after case taking. |
| Comparator Agent |
Placebo |
One group is given Placebo |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of End Stage Kidney Disease on Hemodialysisfrom both the sex of all socio-economic status
Patients of End Stage Kidney Disease on Hemodialysis with comorbidities of Diabetes Mellites, Hypertension, Cardiovascular Diseases.
Patients of End Stage Kidney Disease on Hemodialysis for at least 3Months. |
|
| ExclusionCriteria |
| Details |
End Stage Kidney Disease Patients taking treatment for any other systemic disorder except morbidities leading to End Stage Kidney Disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome will be assessed in terms of:
1.Improved
2.Not Improved |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT IN QUALITY OF LIFE IN PATIENT ON BASIS OF KDQOL |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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) |
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
|
|