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CTRI Number  CTRI/2024/09/074033 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 14/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic treatment by fifty millesimal potency for reducing serum uric acid 
Scientific Title of Study   A single group pre post interventional study to assess the effectiveness of Individualized Homoeopathic Medicines of Fifty millesimal potency in the management of Hyperuricemia using Kents Repertory 
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 Aiswarya Mahankuda 
Designation  Post graduate trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Mahesh Bhattacharya Homoeopathic medical college and hospital,Department of Repertory opd-1 and 9 Dr bholanath chakraborty sarani doomurjala howrah

Haora
WEST BENGAL
711104
India 
Phone  9692885188  
Fax    
Email  aiswaryamahankuda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Purnendu Ash 
Designation  Reader Department of Repertory 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Mahesh Bhattacharya Homoeopathic medical college and hospital,Department of Repertory opd-1 and 9 Dr bholanath chakraborty sarani doomurjala howrah

Haora
WEST BENGAL
711104
India 
Phone  9051420436  
Fax    
Email  purnendubhms29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aiswarya Mahankuda  
Designation  Post Graduate Trainee 
Affiliation  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital 
Address  Mahesh Bhattacharya Homoeopathic medical college and hospital,Department of Repertory opd-1 and 9 Dr bholanath chakraborty sarani doomurjala howrah

Haora
WEST BENGAL
711104
India 
Phone  9692885188  
Fax    
Email  aiswaryamahankuda@gmail.com  
 
Source of Monetary or Material Support  
Mahesh Bhattacharya Homoeopathic medical college and hospital,Department of Repertory opd-1 and 9 Dr bholanath chakraborty sarani doomurjala howrah ,India,pin-711104  
 
Primary Sponsor  
Name  Dr Aiswarya Mahankuda 
Address  Mahesh Bhattacharyya Homoeopathic Medical College and Hospital Department of Repertory Dr bholanath chakraborty sarani doomurjala howrah pin-711104 India 
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 Aiswarya Mahankuda  Mahesh Bhattacharyya Homoeopathic Medical and Hospital  Mahesh Bhattacharya Homoeopathic medical college and hospital,Department of Repertory opd-1 and 9 Dr bholanath chakraborty sarani doomurjala howrah pin-711104 India
Haora
WEST BENGAL 
9692885188

aiswaryamahankuda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic Medicine  All patients enrolled in the study will be receiving fifty millesimal potency of indivisualised homoeopathic medicine on the basis of indivisualization for total 6 months in interval of every 1 month.All medicines procured will be gmp certified.1 spoon of Medicine will be taken in empty stomach after giving 10 downward stroke of the medicine glass bottle of 60ml.Along with medicine the patient will receive diatery advice.Diet management according to patients requirement. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient reporting with serum uric acid more than 6.0 mg per dl in women and more than 7 mg per dl in men for last six months
Age18 to 70 year
Patient is not taking any medication for same complaints for at least 1 months
Patients who are not undergo Homoeopathic treatment for last 2 weeks
 
 
ExclusionCriteria 
Details  Diagnosed case of unstable mental or psychiatric illness
Secondary causes of Hyperuricemia with advanced pathology like Leukaemia Lymphoma Tumor lysis syndrome
Pregnant and lactating mothers
Substance abuse and/or dependence
Self reported cases of immune compromised state
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in serum uric acid level by assessing Uric acid reports   Each patient will get follow up for at least six months at interval of one month 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement of quality of life by Eq 5d 5l Questionnaire  Each patient will get follow up for at least six months at the interval of one month 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   28/09/2024 
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 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  

INTRODUCTION- Hyperuricemia  is a metabolic disorder characterized by increased blood serum uric acid.Normal serum uric acid range for male is 2-7 mg per dl and for female is 2-6mg per dl . International classification of Diseases eleventh revision having code( 5C55.Y- other specified inborn error of purine, pyrimidine or nucleotide metabolism) for HU.  Most people with HU are asymptomatic (85% to 90%), but elevated SUA in the blood or urine can lead to gout or nephrolithiasis. HU is defined as an elevated serum uric acid level, usually greater than 6 mg per dL in women and 7 mg per dL in men. Environmental exposures like lead exposure, extreme temperature fluctuations, and physiologic stress have been found to trigger gouty flares.  It is seen that 21% of the general population and about 25% of the hospitalized patients had asymptomatic HU worldwide .Data on updated hyperuricemia prevalence in Beijing-Tianjin-Hebei  region in China shows that the prevalence of hyperuricemia was 19.37%, 27.72% in men and 10.69% in women. National Health and Nutrition Examination Survey (NHANES) data shows that the prevalence rate of HU is 20.2%  in men and 20.0% in  women  in the year 2015 to 2016 in the U.S. population.In Birbhum district of west Bengal an observational study was held which results showed that 13 among 405 people (3.2%) have found elevated serum uric acid level more than 7.0 m per dl. Modern medicines uses urate-lowering medications like Xanthine oxidase inhibitors (XOI), classified as purine-like (allopurinol and oxypurinol) and non-purine (febuxostat and topiroxostat) XOI for treatment of HU although some studies have shown that they are having many adverse effects. The five most commonly reported side effects were musculoskeletal symptoms (7.7% of who received febuxostat); upper respiratory tract symptoms (5.4%); abnormality in liver function values (4.7%); diarrhoea (3.6%); headache (2.8%). Among 122 Chinese herbal medicines some are having positive role in inhibiting Xanthine oxidase inhibitors are Glabrous greenbrier rhizome, radix puerariae, mangiferin, celery, turmeric, motherwort and berberine.

   JUSTIFICATION OF THE STUDY-Hyperuricemia is a chronic disorder due to abnormal purine metabolism. There are evidences of cure of other metabolic diseases with Fifty Millesimal potencies are more significant and favourable as compare to centesimal potencies.The Previous studies on HU have been done with Centesimal potency but studies are scarce using Fifty millesimal potency as it was introduced by Dr Hahnemann to control the aggravations after using Centesimal potency in chronic pathological disorders. Modern medicines use urate lowering medicines like Xanthine oxidase inhibitors having adverse side effects leads to cause other systemic diseases. HU has characteristic symptoms as well as a generalized presentation. In such cases, selection of siminimum can be assorted with the help of Kent’s repertory. As it has more general symptoms of mental (527 rubrics) as well as physical (245 rubrics) which will help to reflect the inner essence of the sick. This study is undertaken to see the efficacy of Fifty millesimal Potency of individualized Homoeopathic Medicines in treatment of HU using Kent’s repertory.

RESEARCH QUESTION- Is individualized homoeopathic medicine in Fifty Millesimal potency effective in treating and improving health related quality of life of hyperuricemia patients using Kent’s repertory?

HYPOTHESIS-

Null Hypothesis(H0): Individual homoeopathic medicines in fifty Millesimal potency using Kent’s repertory are not effective in treating and improving health related quality of life of Hyperuricemia patients

Alternative Hypothesis (HA): Individual homoeopathic medicines in Fifty Millesimal potencies using Kent’s Repertory are effective in treating and improving health related quality of life in hyperuricemia patients. 
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