| CTRI Number |
CTRI/2024/04/065433 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study to assess the role of Homoeopathic medicines in the management of Gout |
|
Scientific Title of Study
|
An Interventional Prospective Clinical Study To Assess The Role Of Indicated Homoeopathic Medicines In The Management Of Gout |
| 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 Pooja Patidar |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Materia Medica Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9399190819 |
| Fax |
|
| Email |
drppoojapatidar15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Materia Medica Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9785835468 |
| Fax |
|
| Email |
jyotisharmasky11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Patidar |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital And Research Centre |
| Address |
Department Of Materia Medica Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9399190819 |
| Fax |
|
| Email |
drppoojapatidar15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Materia Medica Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital And Research Centre A
Constituent College Of Homoeopathy University Saipura, Sanganer, Jaipur, Rajasthan, 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| Type of Sponsor |
Private 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 Pooja Patidar |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department Of Materia Medica OPD Room No 4 Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
9399190819
drppoojapatidar15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Homoeopathy University Jaipur |
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 |
Indicated Homoeopathic Medicine |
According To The Requirement Of Patients Susceptibility And Homoeopathic Principles Homoeopathic Medicine Shall Be Given Orally Potency 6C And 30C Will Be Given In 2 Globlues Size 40 Dosage And Repetition TDS Per Day And If Higher Potency Will Be Given In 200C And Above Then A Single Dose 4 globules Of It Shall Be Followed By Placebo 2 Globules Dosage And Repetition TDS Per Day Reassessment At The End Of 3 Months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
As per the following list of clinical features shown by the patient If four symptoms should be found out of eight symptoms the cases shall be enrolled for the study
1 Serum urate level more than 6mg/dl in women and more than 7mg/dl in men
2 More than one attack of acute arthritis maximum inflammation developed in one day
3 Redness observed in joints
4 Unilateral first MTP joint painful or swollen
5 Unilateral tarsal joint attack
6 Asymmetrical swelling within a joint
7 Tophus or Subcortical cysts without erosion on x ray
8 History of complete termination of an attack after treatment
Pre diagnosed cases of gout patients who are seeking for homoeopathic treatment |
|
| ExclusionCriteria |
| Details |
1 Pregnant women and lactating women are not included
2 Patient who need emergency treatment
3 Patient with severe systemic illness
4 Patients who are not willing to give written consent for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained (pre and post treatment) from the Numeric Rating scale (NRS) |
Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of 12 weeks using Numeric Rating scale (NRS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is expected that at end of study Homoeopathic medicines will manage the pain
and reduce the reading of serum uric acid level in the cases of Gout |
12 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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 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
|
AIM- to ascertain the effectiveness of indicated homoeopathic medicines in the
management of cases of goutOBJECTIVE- To assess the effect of indicated homoeopathic medicines for the management of
pain in the cases of gout through comparison of pre and post treatment NRS
scores To ascertain the effect of indicated homoeopathic medicines in cases of gout
through observing the changes in serum uric acid levels |