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CTRI Number  CTRI/2024/05/068084 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 01/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic management of cystitis. 
Scientific Title of Study   To assess the utility of individualized homoeopathic medicine in management of cystitis. A single arm open label interventional 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  Bilal Khan 
Designation  Postgraduate Trainee 
Affiliation  State National Homoeopathic Medical College And Hospital 
Address  Department of Materia Medica, State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomtinagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  8630942716  
Fax    
Email  bilalk13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anirudh Kumar 
Designation  Reader 
Affiliation  State National Homoeopathic Medical College And Hospital 
Address  Department of Materia Medica, State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomtinagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  8787010207  
Fax    
Email  kumardranirudh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anirudh Kumar 
Designation  Reader 
Affiliation  State National Homoeopathic Medical College And Hospital 
Address  Department of Materia Medica, State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomtinagar Lucknow

Lucknow
UTTAR PRADESH
226010
India 
Phone  8787010207  
Fax    
Email  kumardranirudh@gmail.com  
 
Source of Monetary or Material Support  
State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomtinagar Lucknow- 226010 Uttar Pradesh, India 
 
Primary Sponsor  
Name  Dr. Bilal Khan 
Address  Department of Materia Medica, State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomtinagar Lucknow 
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 Bilal khan  State National Homoeopathic Medical College And Hospital  OPD No.- 6, Department of Materia Medica, State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomtinagar Lucknow-226010 UP, India.
Lucknow
UTTAR PRADESH 		 8630942716

bilalk13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethical Committee State National Homoeopathic Medical College And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N30||Cystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualize Homoeopathic Medicine.  Intervention- The individualized homoeopathic medicine will be selected according to the totality of symptoms. Dosage- Medicine will be given in varying potencies of decimal/ centesimal/ millesimal scales as identified from detailed case taking.Each dose shall consist of cane sugar medicated with single medicine. Route-Medicine will be administered via oral route. Dosage and repetition will depend upon the individual requirement of the cases as per the guidelines from organon of medicine. The patient will be called for follow up after every 15 days and final assessment will be done after 6 months. At every follow up after reexamining the case it will be decided whether the patient will receive a dose of individualized homoeopathic medicine or placebo.  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients of all age group.
2. Patients of all sexes.
3. Diagnostic criteria are mainly on clinical presentation and urine culture will be done when required.
4. Patient willing to participate in study and provide written consent.

 
 
ExclusionCriteria 
Details  1. Patients not willing to participate in the study.
2. Any medical condition or disease which might interfere with the assessments (e.g.MR, Hearing impairment or speech problems).
3. Patients suffering from Malignancy, Tuberculosis and Systemic disorders such as Diabetes Mellitus, Thyroid dysfunction etc.
4. Patients who require emergency medical treatment.
5. Cases of interstitial cystitis, hemorrhagic cystitis, malakoplakia, cystitis cystica.
6. Pregnant and lactating women.
7. Patient participating in any other clinical study.
8. Cases that do not fulfill the inclusion criteria.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the UTI SIQ 8
Score at baseline and after 6 months of
treatment to know the utility of individualized
homoeopathic medicine. 		 12weeks, 24 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Urine culture results at baseline and after 3 months of
treatment to know the utility of individualized
homoeopathic medicine. 		 4 weeks, 12 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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
Modification(s)  		 Phase 1 
Date of First Enrollment (India)   11/06/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 is an open label, single arm, prospective, interventional study which aims to assess the utility of individualized homoeopathic medicine in the management of cystitis. Individualized homoeopathic medicine will be prescribed in decimal/ centesimal/ millesimal scale after detailed case taking and repertorization. UTI SIQ-8 Score will be calculated pre and post- treatment and the difference will be compared and analyzed.

Cystitis in female population and people of old age group is quite prevalent and imposes a significant disease burden in society. Conventional method of treatment relies heavily on antibiotics. 2022 Global Antimicrobial Resistance and Use Surveillance System (GLASS) reports, it is quite concerning that the median reported rates in 76 countries are 42% for third-generation cephalosporin-resistant E.Coli and 35% for methicillin resistant Staphylococcus aureus. A more holistic approach is required for the treatment of cystitis by considering their mental, physical, spiritual and economical aspects. This approach is not new for Homoeopathic mode of treatment because in Homoeopathy we always treat the patient with a holistic approach by considering the individuality of the patient.

Therefore, the present study is undertaken to explore how individualized homoeopathic medicine selected on the basis of totality of symptoms can prove to be useful in the treatment of cystitis.

 

 
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