| CTRI Number |
CTRI/2025/10/096619 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EVALUATE THE ROLE OF HOMOEOPATHIC MEDICINE IN CASES OF GOUT |
|
Scientific Title of Study
|
An Interventional Study to Evaluate The role of Individualized Homoeopathic Medcine In Cases of Gout |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
OM PRAKASH |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research institute |
| Address |
Dept. of Practice of Medicine Ground floor PG Block Near RIICO Bus Stand Hanumangarh Road Ganganagar Rajasthan
Ganganagar RAJASTHAN 335002 India |
| Phone |
8696836019 |
| Fax |
|
| Email |
omprakashparmar017@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anil Aggarwal |
| Designation |
HOD and Professor Dept. of Practice of Medicine |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research institute |
| Address |
Dept. of Practice of Medicine Ground floor PG Block Near RIICO Bus Stand Hanumangarh Road Ganganagar Rajasthan
Ganganagar RAJASTHAN 335002 India |
| Phone |
9929319610 |
| Fax |
|
| Email |
aggarwal.anil1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
OM PRAKASH |
| Designation |
PG Scholar |
| Affiliation |
Sri Ganganagar Homoeopathic Medical College Hospital and Research institute |
| Address |
Dept. of Practice of Medicine Ground floor PG Block Near RIICO Bus Stand Hanumangarh Road Ganganagar Rajasthan
Ganganagar RAJASTHAN 335002 India |
| Phone |
8696836019 |
| Fax |
|
| Email |
omprakashparmar017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ganganagar Homoeopathic medical college, hospital and Research institute, Near RIICO Bus stand, Hanumangarh Road, Sri Ganganagar, Rajasthan 335002 |
|
|
Primary Sponsor
|
| Name |
Sri Ganganagar Homoeopathic medical college hospital and Research centre |
| Address |
Near RIICO Bus stand Hanumangarh Road Sri Ganganagar Rajasthan 335002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Om Prakash |
Sri Ganganagar Homoeopathic medical college hospital and Research institute |
Sri Ganganagar Homoeopathic medical college hospital and Research institute Near RIICO Bus stand Hanumangarh Road Sri Ganganagar Rajasthan 335002 Ganganagar RAJASTHAN |
8696836019
omprakashparmar017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Ganganagar Homoeopathic Medical College hospital and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathy |
Individualized Homoeopathic
Drugs |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
The patient between the age 18 to 45yr.
The patient diagnosed with high Uric acid level and nephrolithiasis secondary to hyperuracaemia.
The patient giving consent and willing to participate in the study and maintaining follow up |
|
| ExclusionCriteria |
| Details |
Patient with other severe systemic illness of gout.
patient on other analgesic medicine or Co morbidity. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduce pain and redness
2.comparative effectiveness to identify statistical significance between two groups
|
1.Reduce pain and redness within 8 weeks
2.comparative effectiveness to identify statistical significance between two groups after 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="0" 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: Intra-articular sodium urate crystals and hyperuricaemia accompany gout, a type of inflammatory arthritis. Red, sore, swollen joints occur frequently in gout attacks. In addition to plasma urate levels higher than 6.0 mg/dl, the presence of monosodium urate monohydrate crystals in the afflicted area is crucial for diagnosis. Menopausal women and middle-aged men have excruciating pain, swelling, and redness in the first MTP joint when they first get acute gout. Alcohol, overindulgence in food, dehydration, and diuretic medication are the usual causes of this acute. People who have persistently elevated levels of uric acid may also have chronic tophaceous gout, and sodium urate can cause tophi, or smooth white deposits, in the skin and surrounding joints. One to four percent of the general population suffers with gout. In Western nations, it affects 3-6% of men and 1% of women. A gout patient’s mind becomes more irritable due to constant discomfort, which has an indirect impact on his personal and professional lives. Their general health and quality of life are greatly impacted by their inability to sleep soundly and their difficulty walking. The optimum time to take precautions is before the sickness manifests. Medication and physical therapy assist the patient in overcoming gout once it has been proven. Gout risk can be reduced by leading a lifestyle that includes nutritious food, frequent exercise, and joint mobility. However, Homeopathy operates in a different way. It is an individualisation science in which every individual is seen as unique and all symptoms-physical. emotional, and mental-were included in a case study. (1)
AIM
To ascertain the role of Individualized Homeopathic medicine in cases of gout.
OBJECTIVES
1. To assess the effectiveness of individualized Homeopathic medicine by comparing pre and post score of NUMERICAL RATING SCALE
2. To evaluate changes in serum uric acid level, following treatment with individualized homoeopathic medicine. |