FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078222 [Registered on: 17/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Role of boger boenninghausen’s characteristics and repertory in homoeopathic management of hyperuricemia. 
Scientific Title of Study   Usefulness of boger boenninghausen’s characteristics and repertory in homoeopathic management of hyperuricemia by considering rubric uric acid diathesis a prospective single arm pre post clinical study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Khanai 
Designation  PG Scholar 
Affiliation  Bakson Homoeopathic Medical College and Hospital 
Address  Department of Repertory Basement Room no B15 Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge park Phase 1 Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  07737640074  
Fax    
Email  anjali.khanai40.ak@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Nagar 
Designation  Guide & Associate Professor 
Affiliation  Bakson Homoeopathic Medical College and Hospital  
Address  Department of Repertory Basement Room no B15 Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge park Phase 1 Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9899198690  
Fax    
Email  dr.neha678@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashwini Nair 
Designation  HOD & Pg incharge 
Affiliation  Bakson Homoeopathic Medical College and Hospital  
Address  Department of Homoeopathic Materia Medica Second floor Room no S1 Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge park Phase 1 Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9990178024  
Fax    
Email  pginchargebakson@gmail.com  
 
Source of Monetary or Material Support  
Bakson Homoeopathic Medical College And Hospital Plot no 36 B Knowledge park Phase 1 Greater Noida Gautam Buddha Nagar  Pincode 201310 Uttar Pradesh India  
 
Primary Sponsor  
Name  Bakson Homoeopathic Medical College and Hospital 
Address  Principal office Ground floor Room No G22 Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge Park Phase 1 Greater Noida Gautam Buddha Nagar  Uttar Pradesh Pincode 201310 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjali khanai  Bakson Homoeopathic Medical College and Hospital  Outpatient department (ODP) Ground Floor Room No 1 Bakson Homoeopathic Medical College and Hospital Plot no 36 B Knowledge Park Phase 1 Greater Noida Pin code 201310
Gautam Buddha Nagar
UTTAR PRADESH 		 7737640074

anjali.khanai40.ak@gmail.com 
Dr Anjali khanai  Dr D P Rastogi Central Research Institue of Homoeopathy  Outpatient Department (OPD) Ground Floor A1/1 Room No 110 Sector 24 Nodia 201301
Gautam Buddha Nagar
UTTAR PRADESH 		 7737640074

anjali.khanai40.ak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Bakson Institutional Ethics Committee   Approved 
kendriya Homoeopathy Anusandhan Parisad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E79||Disorders of purine and pyrimidinemetabolism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine   Pill form 30 size pills oral route of administration centesimal scale first dose at the time of case taking subsequent doses according to follow ups upto 6 months 
Comparator Agent  NIL  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Participants of age group 18-59 year
Male with SUA level more than 7 mg/dl and female with more than 6.0 mg/dl
Participants willing to give consent will be included
Uric acid diathesis as Eliminating Rubric

 
 
ExclusionCriteria 
Details  Participants with unstable mental or psychiatric diseases, uncontrolled or severe systemic illnesses, substance abuse, severe endocrine disorders, and already receiving homeopathic treatment for any chronic condition for past 3 months
Pregnant and lactating females
Recurrent case of renal stone
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It is expected that there will be reduction in serum uric acid level of patients.
There will be improvement in patient’s outcome without any substantial medical adverse effect hence a significant reduction in serum uric acid level is expected as compared to baseline and at 6 months.
 		 15 months study
Enrollment – 6 months
follow up – 6 months
Statistical analysis – 3 months
first dose after case taking subsequent doses as per follow ups



 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Not Applicable 
 
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   N/A 
Date of First Enrollment (India)   30/12/2024 
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="3"
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 is an prospective observational study to assess the effect of boger boenninghausen’s characteristics and repertory in homoeopathic management of hyperuricemia by considering rubric uric acid diathesis
Sample size of the study is 35
It is expected that there will be reduction in serum uric acid level of patients.
There will be improvement in patient’s outcome without any substantial medical adverse effect hence a significant reduction in serum uric acid level is expected as compared to baseline and at end of 6 months.

 
Close