| CTRI Number |
CTRI/2025/02/080562 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Individualized homoeopathic medicine in gout using kents method of evaluation of symptoms |
|
Scientific Title of Study
|
Role of individualized homoeopathic medicine in management of gout according to kents method of evaluation of symptoms |
| 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 Shruti Dixit |
| Designation |
Post Graduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8171104641 |
| Fax |
|
| Email |
shrutidixit126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archna Kumari |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9450522295 |
| Fax |
|
| Email |
archna505@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Dixit |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8171104641 |
| Fax |
|
| Email |
shrutidixit126@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out Patient Department of State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Dixit |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy State National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow |
| 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 Shruti Dixit |
State National Homoeopathic Medical College and Hospital Lucknow |
OPD-8 Department of Organon of Medicine and Homoeopathic philosophy Sate National Homoeopathic Medical College and Hospital Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH |
8171104641
shrutidixit126@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of State National Homoeopathic Medical College and Hospital Lucknow |
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 Medicine according to Kents method of evaluation of symptoms |
Patients qualifying to inclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital. Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization using Repertory of the Homoeopathic Materia Medica by James Tyler Kent. Indicated homoeopathic remedy will be administered as per the requirement to the case or condition in appropriate potency (30 CH, 200 CH,1M) and appropriate doses. Medicines will be given oral route. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrolment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on Gout Impact scale scoring between 0 to 100. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
.Patients fulfilling the diagnostic criteria of Gout.
.Serum urate levels equal to or more than 6.8mg per dl.(According to WHO)
.Individuals with a family history of gout.
.Patients aged 18 to 60 years.
|
|
| ExclusionCriteria |
| Details |
.Patients with any severe systemic illness.
.Pregnant females, lactating mothers, and women who are planning for pregnancy.
.Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of individualized homoeopathic medicine selected using Repertory of Homoeopathic Materia Medica by James Tyler Kent using Gout Impact Scale before and after the treatment. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
.At the end of the study it is expected that Homoeopathic medicine selected on the basis of individualization according to Kents approach will prove effective in the management of Gout.
.The study will determine whether the Quality of Life of the patients suffering from Gout can be improved by using Individualized Homoeopathic Medicine. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/02/2025 |
| 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 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 a type of inflammatory arthritic disorder characterized by
sudden, severe joint pain, swelling and limited joint mobility caused by
an excess of uric acid in the blood, leading to the formation of sharp,
needle-like urate crystals in the joints. Gout commonly affects the joint at
the base of the big toe (podagra), but it can also occur in other joints such
as ankles, knees, wrists, and elbows. The condition is one of the most common
types of arthritis and is more prevalent in men than women. The risk factors of
gout includes age, sex, obesity, hypertension, diabetes, kidney disease, diet,
genetic factors, cardiovascular diseases.
At the end of study, it is expected that the individualized homoeopathic medicine selected using Repertory of Homoeopathic Materia Medica by James Kent have effective role in the management of patients who are suffering with Gout. It is expected that the patient improves symptomatically which is evident through the valid scale (Gout Impact Scale). This study will further emphasize the importance of mind symptoms in treating patients suffering from chronic systemic illnesses like Gout. |