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CTRI Number  CTRI/2023/09/058095 [Registered on: 27/09/2023] Trial Registered Prospectively
Last Modified On: 26/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study is being conducted to examine the effects of homeopathic medicine with allopathic medicine, in the treatment of chronic kidney disease without dialysis. 
Scientific Title of Study   Evaluate the effectiveness of individualized Homeopathic medicine as a complement therapy with using complete repertory in the management of non-dialysis 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 Paresh Kared  
Designation  Professor  
Affiliation  Shree H N Shukla Homeopathic Medical College and Hospital  
Address  Shree H N Shukla Homeopathic Medical College and Hospital, Shree H N Shukla campus, Amargadh Bichari, near lalpari lake, behind marketing yard, Rajkot, Gujarat

Rajkot
GUJARAT
360003
India 
Phone  9427722763  
Fax    
Email  pareshkared@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jignesh Patel 
Designation  Professor 
Affiliation  Jawaharlal Nehru Homeopathic Medical College 
Address  Jawaharlal Nehru Homeopathic Medical College, Parul University, At and Po lambda, waghodiya, Vadodara

Vadodara
GUJARAT
391760
India 
Phone  9909949221  
Fax    
Email  jignesh.patel79013@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Paresh Kared  
Designation  Professor  
Affiliation  Shree H N Shukla Homeopathic Medical College and Hospital  
Address  Shree H N Shukla Homeopathic Medical College and Hospital, Shree H N Shukla campus, Amargadh Bichari, near lalpari lake, behind marketing yard, Rajkot, Gujarat

Rajkot
GUJARAT
360003
India 
Phone  9427722763  
Fax    
Email  pareshkared@gmail.com  
 
Source of Monetary or Material Support  
Shree H N Shukla Homeopathic Medical College and Hospital, Shree H N Shukla campus, Amargadh Bichari, near lalpari lake, behind marketing yard, Rajkot, Gujarat  
 
Primary Sponsor  
Name  Dr Paresh Kared 
Address  Shree H N Shukla Homeopathic Medical College and Hospital, Amargdh Bhichari, near lalpari lake, Rajkot 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Paresh Kared  Shree H N Shukla Homeopathic Medical College and Hospital  Room no 2, OPD department, Shree H N Shukla campus, Amargadh Bichari, near lalpari lake, behind marketing yard, Rajkot, Gujarat
Rajkot
GUJARAT 		 9427722763

pareshkared@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Homeopathic Medical college - Institutional Ethics Committee For Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N182||Chronic kidney disease, stage 2 (mild), (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (3) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (4) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (5) ICD-10 Condition: N181||Chronic kidney disease, stage 1,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homeopathic medicine, water potency ( 2 drops of selected homeopathic medicine dilutet in 15ml normal water)  Group – I : Experimental group : 35 CKD cases will be received individualised Homeopathic Medicine along with Allopathic Treatment for 6 months  
Comparator Agent  only allopathic medicine as prescribe by nephrologist  Group – II : Controlled group : 35 CKD cases will be only Observed, without Homeopathic Treatment along with Allopathic Treatment for 6 month  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. The samples will be selected from both sexes, & adolescent to old age group.
2. All stages of Chronic kidney disease (without dialysis) cases with allopathic medicine.
3. Chronic kidney disease associated with Diabetes, Hypertension, Glomerulonephritis, or any other auto immune diseases will be included with their allopathic medicine.
 
 
ExclusionCriteria 
Details  1. Chronic kidney disease with dialysis or kidney transplantation.
2. Chronic kidney disease in children.
3. Chronic kidney disease with any other alternative therapy
treatment like ayurvedic treatment.
4. Chronic kidney disease with Arthritis cases or cases requires
NASAID medicine.
5. Acute kidney diseases.
6. Chronic kidney diseases with pregnancy and breast feeding
cases
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Glomeruli filtration rate (GFR), Creatinine and CKD stage progression   3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Effect of Individualised homeopathic medicine from complete repertory according to KIDGO classification (GFR classification)   6 month 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   10/10/2023 
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="0"
Months="6"
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   Chronic Kidney Disease (CKD) is becoming a significant chronic illness globally. Indeed, it has been recently estimated that the age-adjusted incidence rate of ESRD ( end stage renal diseases) in India is 229 per million population, and >100,000 new patients enter renal replacement programs annually in India. in India, there is a prevalence rate of CKD of around 17% and it is worse in stage 3 with a 6% rate. Preventing ESRD is crucial for population health and Economic burden. CKD are a condition in which the kidneys are damaged due to changes in the structure or function of glomeruli. The progression of this condition can lead to kidney and cardiovascular failure. KIDGO defines CKD as kidney damage or glomerular filtration rate 60ml/min/1.73m2 for 3 moths or more, regardless of the causes. Although there are few single medicine trials that support the efficacy of homeopathic medicine for CKD, systematic reviews recommend that future trials of homeopathy be conducted. This trials is designed to assess the complementary efficacy of individualised homeopathic medicine selected through Complete Repertory along with allopathic medicine in the treatment of CKD on 70 OPD patients in an open label, non-randomised (odd-even), controlled experimental design at H N Shukla homeopathic medical college and Hospital, Rajkot. The patients will receives either individualised homeopathic medicine along with allopathic medicine or solely allopathic medicine and will be monitored for 6 months. Data will be gathered using GFR and Serum Creatinine calculation at baseline, after 3 months, and 6 months. Statistical analysis will be used to evaluate the intent to treat the population. To examine any differences between groups, a comparative analysis will be conducted. The outcome will be published in scientific journals. 
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