| CTRI Number |
CTRI/2024/06/068703 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to understand effect of homoeopathic medicines in persons with gout by decreasing uric acid level in blood |
|
Scientific Title of Study
|
A Clinical Study On Reducing The Serum Uric Acid Level In Gout Patients With Homoeopathic Medicines |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revathi Ravindran N |
| Designation |
PG Scholar |
| Affiliation |
DR.MGR Medical University Chennai,White Memorial Homoeopathic Medical College And Hospital |
| Address |
Department of Practice of Medicine, White Memorial Homoeo Medical College and Hospital,Attoor,Veeyannoor PO Kanniyakumari District,India
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9745566843 |
| Fax |
|
| Email |
revathinammily@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Priya Rajini RM |
| Designation |
Associate Professor, Department of Practice of Medicine |
| Affiliation |
White Memorial Homoeo Medical College And Hospital |
| Address |
Department of Practice of medicine,White Memorial Homoeo Medical College And Hospital Attoor,Veeyanor PO Kanniyakumari Dsitrict,India
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
7598188281 |
| Fax |
|
| Email |
drpriyarm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Revathi Ravindran N |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeo Medical College And Hospital |
| Address |
Department of Practice of Medicine White Memorial Homoeo Medical College And Hospital, Attoor,VeeyanoorPost,Kanniyakumari District,India
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9745566843 |
| Fax |
|
| Email |
revathinammily@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Practice Of Medicine, White Memorial
Homoeopathy Medical College and Hospital, Attoor, kanniyakumari,Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Department of Practice of MedicineWhite Memorial Homoeo Medical College And Hospital |
| Address |
White Memorial Homoeo Medical College And Hospital, Attoor ,Veeyannoor ,Pincode 629177 Kanniyakumari District,India |
| 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 |
| DrRevathi Ravindran |
White Memorial Homoeo Medical College & Hospital |
Department of Practice of Medicine ,OPD unit, IPD unit , Peripheral centers
Kanniyakumari
TAMIL NADU |
9745566843
revathinammily@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee White Memorial Homoeopathic Medical College and Hospital |
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 |
Homoeopathic Medicine |
Assesment of Serum uric acid level will be done at 3 months interval |
| Intervention |
Homoeopathic medicine |
Each case will be reviewed at one month interval as per their need in case of emergency and it will be followed up for a period of 6 months |
| Intervention |
Homoeopathic Medicine |
Homoeopathic medicines selected based on symptom similarity will be admimistered to the patients in the proper dose,potency,and repetition of medicine according to homoeopathic principles. |
| Intervention |
Homoeopathic Medicine |
Potency - based on susceptibility of the participant
Dose - Minimum dose
Route of administration- Oral |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases Of Gout
Symptomatic Patients suffering from gout with high uric acid levels above 6.8mg/dl |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients with other systemic diseases such as high blood pressure and diabetes
Patients who are taking other medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Each case is assesed by the serum uric acid level .Each case will be reviewed at one month interval or as per their need in case of emergency |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After completion of study,follow up and assesment of serum uric acid will be done |
1 year |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [revathinammily@gmail.com].
- For how long will this data be available start date provided 25-12-2025 and end date provided 25-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
30 caes of gout satisying 2015 ACR EULAR Criteria with increased serum uric acid level above 6.8 mg/dl are taken from the inpatient and outpatient ,peripheral centers of White Memorial Homoepathic medical college subjects will be screened ,after case taking and repertorisation individualized homoeopathic medicines selected , every change in serum uric acid level is recorded |