| CTRI Number |
CTRI/2025/06/089338 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicines in reducing high uric acid levels |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines in LM potency in hyperuricemic individuals - A quasi experimental 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 |
T Vinothini |
| Designation |
Post Graduate Scholar, Department of Practice of Medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Room no- 146,
2nd floor,
Sachivothamapuram (po), Kurichy, Kottayam,Kerala.India
Kottayam
KERALA
686532
India |
| Phone |
6380338466 |
| Fax |
|
| Email |
vinobuddy555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sitharthan |
| Designation |
Principal, Professor , HOD, Department of practice of medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Room no:101,
1st floor
Sachivothamapuram (po), Kurichy, Kottayam,Kerala.India
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sitharthan |
| Designation |
Principal, Professor , HOD, Department of practice of medicine |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Room -101
1st floor,
Sachivothamapuram (po), Kurichy, Kottayam,Kerala.India
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (po), Kurichy, Kottayam,Kerala. 686532 , India |
|
|
Primary Sponsor
|
| Name |
Dr T Vinothini |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram (po), Kurichy, Kottayam,Kerala,India.686532 |
| 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 T Vinothini |
National Homoeopathy Research Institute in Mental Health |
OPD of Department of practice of medicine
Room no:146
2nd Floor
Kottayam
KERALA |
6380338466
vinobuddy555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - National Homoeopathy Research Institute in Mental Health |
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 |
Individualized Homoropathic Medicines |
The selected medicine will be given orally in LM potency.The
medicine will be continued, stopped or changed depending upon the improvement of
the patient and in accordance with homoeopathic principles.The above treatment is given for a period of 12 months.In case of any acute complaints, acute totality will be considered and the appropriate
remedy will be administered and documented accordingly |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Serum Uric Acid levels greater than 7 mg/dl |
|
| ExclusionCriteria |
| Details |
Patients with severe comorbidities or complications that may interfere with the
study outcomes (eg end-stage renal disease, liver failure, or severe
cardiovascular disease)
Patients who are on urate lowering drug
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Serum uric acid levels |
Changes in Serum uric acid levels at baseline, 3rd month , 6th month , 9th month ,end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Hyperuricemia quality of life questionnaire |
Baseline and every month |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
04/07/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vinobuddy555@gmail.com].
- For how long will this data be available start date provided 04-07-2025 and end date provided 11-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
This study evaluates the effectiveness of individualized homoeopathic medicines in treating high uric acid levels in hyperuricemic individuals using LM potency through a quasi experimental study. This study is for a period of 18 months ( 6 months enrollment and 12 month follow up ) that will be conducted in National Homoeopathic Research Institute in Mental Health, Kottayam , Department of Practice of Medicine. The primary outcome will measure the changes in serum uric acid levels which is measured every 3 months ( Baseline , 3rd month , 6th month, 9th month and at the end of the treatment). The secondary outcome will assess the changes in Hyperuricemia quality of life questionnaire. By exploring a complementary and potentially safer approach to managing hyperuricemia, this study may provide valuable insights into alternative treatment options for patients with hyperuricemia, ultimately contributing to improved patient care and quality of life. |