| CTRI Number |
CTRI/2024/08/073002 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A study on the effect of Homoeopathic medicine in management of Chronic Kidney Disease |
|
Scientific Title of Study
|
The Effect Of HOMOEOPATHIC MEDICINE As An Add-on Treatment In Patients With CHRONIC KIDNEY DISEASE By Assessing The KIDNEY FAILURE RISK EQUATION-A Quasi Experimental 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 JASIRA K |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical Collage |
| Address |
Department of Practice of medicine
Government Homoeopathic Medical Collage
Karaparamba
Kozhikode
Kerala
India
PIN 673010
Kozhikode
KERALA
673010
India |
| Phone |
9048539659 |
| Fax |
|
| Email |
jasirashameem@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ABDUL HAMEED |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic medical collage |
| Address |
Department of Practice of medicine
Government Homoeopathic medical collage
Karaparamba
kozhikode
pin 673010
India
Kozhikode
KERALA
673010
India |
| Phone |
9447632227 |
| Fax |
|
| Email |
hameeddr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ABDUL HAMEED |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic medical collage |
| Address |
Department of Practice of medicine
Government Homoeopathic medical collage
Karaparamba
kozhikode
pin 673010
India
Kozhikode
KERALA
673010
India |
| Phone |
9447632227 |
| Fax |
|
| Email |
hameeddr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic medical collage ,Karaparamba,Kozhikode,Kerala
India,PIN 673010 |
|
|
Primary Sponsor
|
| Name |
Dr JASIRA K |
| Address |
Post graduate scholar
Department of practice of medicine
Government Homoeopathic medical collage ,Karaparamba Kozhikode ,Kerala
India, PIN 673010
|
| 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 JASIRA K |
Government Homoeopathic medical collage |
Research op and renal op
OP no 9
Department of practice of medicine
Government Homoeopathic medical collage Kozhikode
Kozhikode
KERALA |
9048539659
jasirashameem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical Collage,Kozhikode,Kerala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicine |
We will give Individualised homoeopathic medicine single dose ,potency depends on patients age and condition and medicine should be given for 2 weeks and follow up taken after that. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient with mild to moderate renal dysfunction or patient fulfill the diagnostic criteria of chronic kidney disease ,
Patient willing to take homoeopathic medicine along with conventional treatment. |
|
| ExclusionCriteria |
| Details |
Patient with End stage renal disease
Patient need emergency management |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of estimated glamerular filtration rate
|
Serum creatinine evaluated every 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of renal function using kidney failure equation |
Urine ACR evaluated 6 month intervel |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 3 |
|
Date of First Enrollment (India)
|
04/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/09/2024 |
| 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
|
This study is to find out the effect of Individualized Homoeopathic medicine in the management of Chronic Kidney disease by evaluating Serum Creatine and Urine ACR .Conservative estimates indicate that in 2010, more than half of all individuals
who need renal replacement therapy worldwide passed away for lack of access to
dialysis or transplantation. The huge cost associated with providing renal replacement
therapy provides a compelling economic incentive for improving the prevention,
detection and management of CKD in low-income and middle-income countries There is no specific medicine for chronic kidney disease in conventional
treatment. The cost of renal replacement therapy is very high and once dialysis started
need to continue for life long, if we can help the community in preventing the
progression of Chronic kidney disease to End Stage Renal Disease (ESRD), it will be
a great thing. Homoeopathy can play an important role in
reducing the morbidity and slowing down the progression. |