| CTRI Number |
CTRI/2025/11/097709 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathic treatment in two potencies for the management of high serum uric acid level |
|
Scientific Title of Study
|
Comparative effectiveness in centesimal and 50 millesimal potencies of individualized homoeopathic medicine prescribed for treatment of patients with hyperuricemia-an open label prospective, randomised controlled trial |
| 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 Shikha Dubey |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7003698893 |
| Fax |
|
| Email |
dubeyysshikhaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapan Paul |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapan Paul |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata 700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
National Institute Of Homoeopathy, GE Block, Sector 3, Salt Lake, Kolkata 700106, West Bengal, 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 Shikha Dubey |
National Institute Of Homoeopathy |
OPD Room No 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt Lake, Kolkata
Kolkata
WEST BENGAL |
7003698893
dubeyysshikhaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of the 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 |
Individualized Homoeopathic Medicine in 50 millesimal potency |
Indicated individualized homoeopathic medicine will be prescribed on the basis of totality of symptom and frequency of the selected medicine will be as per the susceptibility of the case. Follow up will b monthly till 4 months from baseline. |
| Comparator Agent |
Individualized Homoeopathic Medicine in centesimal potency |
Indicated individualized homoeopathic medicine will be prescribed on the basis of totality of symptom and frequency of the selected medicine will be as per the susceptibility of the case. Follow up will b monthly till 4 months from baseline. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Serum uric acid levels more than 7.0 mg per dL in males and more than 6.0 mg per dL in females
2 Symptomatic Hyperuricemia like joint pain swelling restricted mobility
3 Patient who can understand either English or Bengali or Hindi languages
4 Willing to Provide written Informed Consent |
|
| ExclusionCriteria |
| Details |
1 Patients suffering from uncontrolled systemic illnesses or life threatening illnesses
2 Complicated cases of Hyperuricemia like gout, tophi deposits, uric acid stone, chronic
kidney disease
3 Pregnant or lactating women
4 Any substance abuse
5 Patients on any kind of medication for hyperuricemia
6 Unstable psychiatric illnesses |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Uric Acid level |
Baseline, after 2 months and after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MYMOP2 Score |
Baseline,2nd and 4th month |
| MONARCH Score and ADR probability score |
at the
end of treatment 4 month |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
29/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/11/2025 |
| 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
|
This study aims to compare the effectiveness of individualized homoeopathic medicines prepared in two different potencies Centesimal and 50 millesimal in patients with hyperuricemia . Patient aged 18 to 65 years with raised serum uric acid level and symptoms such as joint pain or swelling will receive individualized homoeopathic medicines for the duration of 4 months period .The primary outcome will be the change in blood uric acid levels. Secondary measures include improvement in self reported health MYMOP2 score assessment and causal relation of improvement through MONARCH score and monitoring for any adverse drug reactions. The study will help to determine which potency scale offers better clinical benefit. No new medicine will be trailed. All the medicines will be administered orally. All the medicines will be procured from the GMP certified company. Potency, dose and repetition will be as per the principles of homoeopathy. |