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CTRI Number  CTRI/2022/11/047788 [Registered on: 30/11/2022] Trial Registered Prospectively
Last Modified On: 05/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of homoeopathy in management of kidney stone 
Scientific Title of Study   A PROSPECTIVE STUDY ON THE EFFECT OF HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF UROLITHIASIS BY ASSESSING ULTRASONOGRAM (KUB) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAHLA VP 
Designation  JUNIOR RESIDENT 
Affiliation  GOVT. HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KOZHIKODE 
Address  Department of Practice of Medicine Govt HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA

Kozhikode
KERALA
673010
India 
Phone  8086821342  
Fax    
Email  sahlasalih483@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P Abdul Hameed 
Designation  Professor and HOD,  
Affiliation  Govt Homoeopathic Medical College Hospital 
Address  Department of Practice of Medicine Govt HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA

Kozhikode
KERALA
673010
India 
Phone  9447632227  
Fax    
Email  hameeddr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  SAHLA VP 
Designation  JUNIOR RESIDENT 
Affiliation  GOVT. HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KOZHIKODE 
Address  Department of Practice of Medicine Govt HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA

Kozhikode
KERALA
673010
India 
Phone  8086821342  
Fax    
Email  sahlasalih483@gmail.com  
 
Source of Monetary or Material Support  
Govt Homoeopathic Medical College Hospital kozhikode kozhikode  
 
Primary Sponsor  
Name  SAHLA VP 
Address  Govt Homoeopathic Medical College Hospital kozhikode kerala 673010 
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 SAHLA VP  GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL  KIDNEY CARE CLINIC OUT PATIENT DEPARTMENT NEW BLOCK GROUND FLOOR GOVT HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL KARAPARAMBA
Kozhikode
KERALA 
8086821342

sahlasalih483@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N20-N23||Urolithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HOMOEOPATHIC MEDICINES  SUITABLE HOMOEOPATHIC MEDICINES SELECTED ACCORDING TO SYMPTOM TOTALITY DOSE AND POTENCY WILL BE SELECTED ON THE BASIS OF HOMOEOPATHIC PRINCIPLES ROUTE OF ADMINISTRATION WILL BE ORAL DURATION OF TREATMENT WILL BE 1 YEAR 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Age group from 20- 70years of both sexes.
2.Symptomatic cases of Urolithiasis diagnosed by ultrasonogram(KUB)
3.Size of the stone ranging from 3mm to 20 mm.
 
 
ExclusionCriteria 
Details  1.Cases impacted or with stag horn calculi
2.Gross developmental or structural abnormalities of urinary system(like urethral stricture)
3.Subject of pregnant and lactating women
4.Patients with severe systemic illness like malignancies.
5.Patients who need emergency management.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Significant difference in the Urolithiasis symptom score before and after homeopathic treatment in the subjects with Urolithiasis
2) Significant changes in USG(KUB) before and after homeopathic treatment in the subjects with Urolithiasis
 
6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Significant difference in the Urolithiasis symptom score before and after homeopathic treatment in the subjects with Urolithiasis

 
1 YEAR 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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)   04/12/2022 
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)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The process of forming stone in urinary tract i.e., in the kidney ,bladder, and ureter is referred to as Urolithiasis. Urolithiasis is one of the most painful and the most common disorders of the urinary tract. 80% of stones are composed of calcium oxalate or phosphate. Other stone types include uric acid (9%), struvite (10%), and cystine (1%) stones. 

 It is common, among people of all countries and ethnic groups. It affects about 12% of the world population at some stage in their lifetime  . In India, approximate 50% of the population is affected with renal calculi, which may end up to renal damage or loss of kidney function  . In the UK, the prevalence is about 1.2%, with a lifetime risk of developing a renal stone by age of  60–70. In some regions, the risk is higher, most notably in countries such as Saudi Arabia, where the lifetime risk of developing a renal stone in men aged 60–70 .

Around 97% of urinary stones are found in the kidneys and ureters (kidney stones), the remaining 3% in the urinary bladder and urethra. Urinary stones can range in size from micrometers to several centimeters in diameter. They frequently remain unnoticed for long periods before manifesting themselves—often very painfully—or being discovered incidentally on radiography or ultrasound.

Common risk factors for stone formation include poor oral fluid intake, high animal-derived protein intake, high oxalate intake (found in foods such as beans, beer, berries, coffee, chocolate, some nuts, some teas, soda, spinach, potatoes), and high salt intake.

The mechanism of stone formation is a complex process which results from several physicochemical events including supersaturation, nucleation, growth, aggregation, and retention of urinary stone constituents within tubular cells. These steps are modulated by an imbalance between factors that promote or inhibit urinary crystallization

It commonly presents with flank pain, hematuria, and nausea/vomiting. Focused evaluation with history, examination, and testing is important in diagnosis and management. Ultrasound examination is the most useful investigation to detect the presence, severity and site of obstruction due to stone. It is non-invasive and can be performed repeatedly. Plain X-ray abdomen for kidney, ureter, bladder and urethra (KUBU) will detect the radiopaque stones. Intravenous urography (IVU) helps to assess the renal function apart from detecting the radiolucent stones as filling defect and the level of obstruction.

When we check the intensity of  the suffering and it’s recurrence rate, there  arises an alarming need for better treatment which is cost effective and prevent further stone formation.

RATIONALE OF THE STUDY   

  Shock wave lithotripsy (SWL) is the process of fragmentation of renal or ureteric stones by the use of repetitive shock waves generated outside the body and focused onto the stone.. SWL results in injury to the kidney which may have long-term side effects, such as new onset hypertension.. Currently, use of lithotripsy is waning, particularly with the advent of minimally invasive ureteroscopic approaches.

      SWL can cause vascular trauma to the kidney and surrounding organs. This acute SW damage can be severe, can lead to scarring with a permanent loss of functional renal volume, and has been linked to potentially serious long-term adverse effects. A recent retrospective study linking lithotripsy to the development of diabetes mellitus has further focused attention on the possibility that SWL may lead to life-altering chronic effects. 

  Extracorporeal shockwave lithotripsy (ESWL) devices, new flexible ureterorenoscopes, development of laser fragmentation, semi-rigid and flexible ureteroscopy and the percutaneous nephrolithotomy (PCNL) remain currently the main therapeutic options.   

For stones less than 20mm, extracorporeal lithotripsy remains the standard, but in some cases the possibility of recommending a flexible ureterorenoscopy is possible in first line. For stones more than 20mm, percutaneous nephrolithotomy is the standard treatment, but optional flexible ureteroscopy and extracorporeal lithotripsy are possible

Homeopathy being an individualistic and holistic system of medicine  it can relieve the pain, dissolve the stone, and prevent recurrence and formation of calculi. Rather than treating each condition separately, a constitutional approach can be adopted in Homeopathy. This study is  a honest attempt aimed towards the relief of symptoms and suffering of pateints with urolithiasis.

 
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