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CTRI Number  CTRI/2022/05/042949 [Registered on: 31/05/2022] Trial Registered Prospectively
Last Modified On: 31/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment of kidney stone 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicines in treatment of urolithiasis patients on health-related quality of life : A single group, pre-post interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SABA NISAT BANU 
Designation  POST GRADUATE TRAINEE 
Affiliation  MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  DEPERTMENT OF HOMOEOPATHIC MATERIA MEDICA MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Dr. B. N. Chakraborty sarani Dumurjola Howrah 711104

Haora
WEST BENGAL
711104
India 
Phone  8016922877  
Fax    
Email  sabanisatbanu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MADHABANANDA SAHA 
Designation  PRINCIPAL 
Affiliation  MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  DEPERTMENT OF HOMOEOPATHIC MATERIA MEDICA MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Dr. B. N. Chakraborty sarani Dumurjola Howrah 711104

Haora
WEST BENGAL
711104
India 
Phone  9434230785  
Fax    
Email  drmadhabanandasaha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr MADHABANANDA SAHA 
Designation  PRINCIPAL 
Affiliation  MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL 
Address  DEPERTMENT OF HOMOEOPATHIC MATERIA MEDICA MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Dr. B. N. Chakraborty sarani Dumurjola Howrah 711104

Haora
WEST BENGAL
711104
India 
Phone  9434230785  
Fax    
Email  drmadhabanandasaha@gmail.com  
 
Source of Monetary or Material Support  
Dr. Saba Nisat Banu, Mahesh Bhattacharyya Homoeopathic Medical college and Hospital, Dr. B. N. Chakraborty Sarani, Dumurjala, Howrah, PIN- 711104 
 
Primary Sponsor  
Name  SABA NISAT BANU 
Address  DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA, MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL Dr.B. N. CHaKRABORTY SARANI DUMURJALA HOWRAH -711104  
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 
SABA NISAT BANU  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital  Department of surgery, Dr. B. N. Chakraborty Sarani Dumurjola Howrah 711104
Haora
WEST BENGAL 		 8016922877

sabanisatbanu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONA ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N20||Calculus of kidney and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized homoeopathic medicine  Homoeopathic medicines will be selected based on the presenting complaints and the totality of symptoms. the medicine will be prescribed in centesimal and LM potencies. All the medicines have been throughly proved and the details are written in Materia medica pura 
Comparator Agent  Not applicable   Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients who are diagnosed with renal stone by USG and/or Xray.
2. All sex, of all religions and of all different socio economic status
3. Patients willing to give written consent for participation
 
 
ExclusionCriteria 
Details  1. Patients with gross pathological changes like CA, chronic kidney disease, kidney failure, hydronephosis.
2. Suffering from systemic diseases like Cardiovascular disease, Hepatobiliary disease, Endocrinal disease
3. Insane, non-co-operative patient
4. Stag horn calculi, calculi in pole of kidney
5. Acute retention of urine for more than 24 hours
6. Any developmental or congenital anomaly of kidney
7. Pregnant and lactating mother
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement of each case will be assessed by using USS score index. This scale will help to assess or compare the outcome of the treatment with gradation in particular level. On the basis of the score obtained from this chart, the intensity of the cases will be grouped into mild(1-7), moderate (8-14) and severe (15-22)
Reduction of stone size and also removal of stone will be confirmed by USG reports and x-ray reports.
 		 Follow up will be done on baseline and each follow up at an interval of 4 weeks and sonography at base line and after 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement of the general health related quality of life will be assessed by WISQOL scale  Followed will be done on baseline and each followup at an interval of 4 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   31/05/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sabanisatbanu@gmail.com].

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 31-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary      Urolithiasis is the third most common disease of urinary tract. This disease affects about 12% of the whole mankind at some stage in their life time. The recurrence rate of renal stone between men and female in Asia is 2:1. This condition has been gradually lower down the kidney function and associate with an increase rick of chronic kidney disease and even end stage renal disease and majority of cases are treated by surgical intervention.  So, it consider as a major social and economic problem. Beside this the recurrence rate is also high, and prevention of this recurrence remains to be a serious health issue as it requires better understanding of mechanism involve in stone formation.
RESEARCH QUESTION : Does individual homeopathic medicine produces significant effects in health related quality of life in cases of  urolithiasis?
HYPOTHESIS:
NULL HYPOTHESIS (H0):
Individualized homoeopathic medicine has no role in management of pain and removing of stones in cases of uncomplicated renal stone.
Individualized homoeopathic medicines has no role in improvement of health related  quality of life among such patients
ALTERNATIVE HYPOTHESIS (HA):
Individualized homoeopathic medicine has role in management of the pain and removing of the stones in cases of uncomplicated renal stone.
Individualized homoeopathic medicine has role in improvement of health related  quality of life  among such patients

 
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