| CTRI Number |
CTRI/2025/01/079809 [Registered on: 30/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Use Of Homoeopathy in Hyperuricemia |
|
Scientific Title of Study
|
THE ROLE OF HOMOEOPATHIC MEDICINES USING BOGER BOENNINGHAUSEN’S CHARACTERISTICS & REPERTORY IN HYPERURICEMIA AN OPEN LABEL PROSPECTIVE, CLINICAL 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 |
SHIVAM KUMAR |
| Designation |
POST GRADUATE |
| Affiliation |
National Institute of Homeopathy |
| Address |
National Institute of Homeopathy,
GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106
GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8707870393 |
| Fax |
|
| Email |
sk150460@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avijit shee burman |
| Designation |
Professor |
| Affiliation |
National Institute of Homeopathy |
| Address |
OPD Room No.10 Department of Repertory, National Institute of Homoeopathy, GE Block, Sector 3, Bidhannagar,
Kolkata,
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433392108 |
| Fax |
|
| Email |
asheeburman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avijit shee burman |
| Designation |
Professor |
| Affiliation |
National Institute of Homeopathy |
| Address |
OPD NO.10,Department of Repertory, National Institute Of Homoeopathy, GE Block, Sector 3, Bidhannagar, Kolkata,
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433392108 |
| Fax |
|
| Email |
asheeburman@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of HomeopathyGE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Homeopathy |
| Address |
GE Block, Sector 3, Bidhannagar, Kolkata, West Bengal 700106 INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Shivam kumar |
National Institute of Homeopathy |
OPD NO.10,Departent of Repertory, Block GE Sector 3, Salt lake, Kolkata, West Bengal
700106
Kolkata
WEST BENGAL |
8707870393
sk150460@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy |
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 |
Homoeopathic treatment |
Patients qualifying to inclusion criteria will be included in the study .proper casetaking of all enrolled patientswiil be done in standardized case taking proforma which is being used in National Institute of Homoeopathy.The score of patients using Hyperuricemia Quality of life Questionnaire (HUQoL)will be recorded.homoeopathic medicines will be prescribed to all patients after analysis and evolution of symptoms and proper repertorization by using BBCR repertory.indicated medicine will be adminstrated as decided appropriate to the case or condition in appropriate potency and doses.medicine will be given orally and each case followed up at regular interval as per requirement for 6 months. |
| Comparator Agent |
Not applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with hyperuricemia either with or without active gout symptoms. |
|
| ExclusionCriteria |
| Details |
Patient with high risk to lead kidney disease like nephropathy nephrolithiasis.
Patients in need of surgical interventions & advanced cases with deformities will be
excluded.
Patients with known but controlled systemic diseases.
Patient already undergoing homeopathic treatment of other chronic disease will be
excluded.
Pregnant and lactating mothers.
Patients suffering from uncontrolled systemic illness any psychiatric illness or life -
threatening infections.
Patient both male & female with more than 12 mg/dl Serum uric acid. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Each enrolled case will be followed up monthly, with scores recorded at the time of patient
entry (baseline), and the difference in serum uric acid levels will be assessed in 6 months |
Each enrolled case will be followed up monthly, with scores recorded at the time of patient
entry (baseline), and the difference in serum uric acid levels will be assessed in 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/02/2025 |
| 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
|
Hyperuricemia is a condition where there is an excess of uric acid in the blood. Uric acid is a waste product that is formed when the body breaks down purines, which are found in certain foods and drinks, as well as in the body’s cells. Normally, uric acid is excreted through urine, but when the body produces too much uric acid or fails to excrete enough, it can accumulate in the bloodstream. The primary test for hyperuricemia is a blood test that measures the level of uric acid in the blood. A serum uric acid level greater than 6.8 mg/dL is typically considered elevated and indicates hyperuricemia, though the exact threshold may vary slightly depending on the lab and individual factors. Homeopathic treatment for hyperuricemia aims to address the underlying imbalance in the body that leads to elevated uric acid levels. Homeopathy is a holistic approach that focuses on individualized case taking. medicines will be prescribed by using Boger Boenninghausen’s Characteristics of Repertory. Assessment will be (HUQoL) Hyperuricemia quality of life questionnaire score at base ,six month. |