| CTRI Number |
CTRI/2025/04/085242 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
ROLE OF INDIVIDUALIZED
HOMOEOPATHIC MANAGEMENT IN CASES OF GOUT |
|
Scientific Title of Study
|
TO STUDY THE ROLE OF INDIVIDUALIZED
HOMOEOPATHIC MANAGEMENT IN CASES OF GOUT – A PROSPECTIVE INTERVENTIONAL 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 |
YASH PATIDAR |
| Designation |
PG SCHOLAR |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 401 PG DEPARTMENT OF ORGANON OF MEDICINE, JAWAHARLAL HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
9644160436 |
| Fax |
|
| Email |
patidaryash1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAYANK ROY |
| Designation |
BHMS, MD (HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 402 B DEPARTMENT OF ORGANON OF MEDICINE, JAWAHARLAL HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
7405002111 |
| Fax |
|
| Email |
Dr.mayankroy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAYANK ROY |
| Designation |
BHMS, MD (HOM) |
| Affiliation |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE |
| Address |
ROOM NO 402 B DEPARTMENT OF ORGANON OF MEDICINE, JAWAHARLAL HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, WAGHODIA, VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
7405002111 |
| Fax |
|
| Email |
Dr.mayankroy@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE, PARUL UNIVERSITY, LIMDA, WAGHODIA VADODARA, 391760 |
|
|
Primary Sponsor
|
| Name |
YASH PATIDAR |
| Address |
JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, PARUL UNIVERSITY, WAGHODIA, VADODARA, GUJARAT, 391760 |
| 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 YASH PATIDAR |
JAWAHARLAL NEHRU HOMOEOPATHIC HOSPITAL |
OPD NO 110, DEPARTMENT OF ORGANON OF MEDICINE
Vadodara
GUJARAT |
9644160436
patidaryash1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAWAHARLAL NEHRU HOMOEOPATHIC MEDICAL COLLEGE (INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH) |
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 |
INDIVIDUALIZED HOMOEOPATHIC MEDICINES |
INDIVIDUALIZED HOMOEOPATHIC MEDICINES WILL BE USED IN SELECTIVE POTENCY, AS IN REQUIRED REPETITION FOR 15 DAYS |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
78.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient between the ages of 18 to 78.
2.Patients suffering from chronic gout with high UA levels (27 mg/dL)
3.The gout had to be clinically apparent, with symptoms such as joint pains
4.The patients giving their consent to participate in study. |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Patient with septic arthritis, trauma, renal failure.
3.Patients already undergoing treatment with other system of medicine.
4.Cases with less than 6 follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the role of individualized homoeopathic medicine in Gout
2.To investigate the role of individualized homoeopathic medicine in reducing serum uric acid
levels in gout patients.
3.To improve the quality of life of the patients. |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
GOUT ASSESSMENT QUESTIONNARE 2.O IS USED FOR ASSESSMENT FOR GOUT.
HIGHER SCORE = WORSE CONDITION / GREATER GOUT IMPACT |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
03/06/2025 |
| 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
|
The study is prospective interventional study the role of Individualized Homoeopathic Management in cases of Gout. The study will be conducted in 55 participants which will be enrolled in Jawaharlal Nehru Homoeopathic Medical College Hospital, Vadodara, Gujarat, India. GAQ2 will be used for assessment purpose. The study will be conducted in the time duration of 1 year. |