| CTRI Number |
CTRI/2025/09/094038 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To See The Effectiveness Of Guaiacum Officinale An Homoeopathic Medicine In Cases Of Gout |
|
Scientific Title of Study
|
The Effectiveness Of Guaiacum Officinale In Cases Of Gout : A Clinical Verification 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 |
Dr Sonal Panchmatiya |
| Designation |
Professor , Department Of Homoeopathic Materia Medica |
| Affiliation |
Dr V H Dave Homoeopathic Medical College and Smt SI Patel (I) Homoeopathic Hospital |
| Address |
Room No 4, Department Of Medicine,Dr V H Dave Homoeopathic Medical College And Smt SI Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat 388001
Anand
GUJARAT
388001
India |
| Phone |
9426432585 |
| Fax |
|
| Email |
dr.sonal2705@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Panchmatiya |
| Designation |
Professor , Department Of Homoeopathic Materia Medica |
| Affiliation |
Dr V H Dave Homoeopathic Medical College and Smt SI Patel (I) Homoeopathic Hospital |
| Address |
Room No 4, Department Of Medicine Dr V H Dave Homoeopathic Medical College And Smt SI Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat 388001
Anand
GUJARAT
388001
India |
| Phone |
9426432585 |
| Fax |
|
| Email |
dr.sonal2705@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Mudaliar |
| Designation |
PG Scholar |
| Affiliation |
Dr V H Dave Homoeopathic Medical College and Smt SI Patel (I) Homoeopathic Hospital |
| Address |
Room No 4 Department Of Medicine Dr V H Dave Homoeopathic Medical College And Smt SI Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat 388001
Anand
GUJARAT
388001
India |
| Phone |
8320924779 |
| Fax |
|
| Email |
aparnamudaliar10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr V H Dave Homoeopathic Medical College And Smt SI Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat 388001 |
|
|
Primary Sponsor
|
| Name |
Dr Aparna Mudaliar |
| Address |
Block No 69 Room No 1644 Gujarat Housing Board Meghaninagar Ahmedabad Gujarat 380016 |
| 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 Aparna Mudaliar |
Smt SI Patel (I) Homoeopathic Hospital Hahnemann House Amul Dairy Road Anand Gujarat 388001 |
Room No 4 Department Of Medicine Dr V H Dave Homoeopathic Medical College Hahnemann House Amul Dairy Road Anand Gujarat 388001
Anand
GUJARAT |
8320924779
aparnamudaliar10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC VHDHMC |
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 |
Guaiacum officinale |
Prescription will be made after matching the totality of symptoms of the case with that of the medicine.
The potency of Guaiacum officinale will be selected
depending upon the susceptibility of the patient.
Case will be reviewed every
7/15 days depending upon the
requirement of the case. |
| Comparator Agent |
No comparator |
No comparator |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed and diagnosed cases of gout presenting clinically where Guaiacum officinale will be indicated based on symptomatology.
Patient between the age group of 20 - 60 years, irrespective of gender. |
|
| ExclusionCriteria |
| Details |
Pregnant female and breastfeeding female will be excluded from the study.
Cases with irreversible pathology or deformity changes will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Specially Formulated And Validated Disease Intensity Score |
At Baseline And At The End Of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Uric Acid |
At Baseline And At The End Of Treatment |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
01/10/2025 |
| 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="0"
Months="9"
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
|
Gout is the most common form of inflammatory arthritis causing joint disease. The prevalence and incidence of gout are increasing in population due to changes in diet, lifestyle and other factors. The study titled "The Effectiveness of Guaiacum Officinale in Cases of Gout: A Clinical Verification Study" is to see the effectiveness of Guaiacum officinale in clinical cases of gout . Homeopathic remedy Guaiacum officinale is indicated in rheumatism and gout with stiffness, swelling and pain.
The study will be conducted as an uncontrolled clinical trial on sample size of 33 patients aged between 20-60 years , irrespective of gender .The study site will be Smt.S.I Patel (I) Homoeopathic Hospital Anand and the study will be conducted over nine months .The outcome will be measured using Disease intensity score and Serum uric acid level in order to study the effect of Guaiacum officinale in cases of gout. Treatment outcome will be statistically assessed using Paired -t test.
|