| 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
|
|
|
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
|
|
|
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. |