| CTRI Number |
CTRI/2024/10/075608 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Asses The Effectiveness Of Personalised Homoeopathic Treatment For Managing Gout Between Attacks :A Clinical Study |
|
Scientific Title of Study
|
To Study The Effectiveness Of Individualised Homoeopathic Medicine In The Management Of Intercritical Period Of Gout - A Clinical 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 |
Vaishnavi Raut |
| Designation |
PG RESIDENT |
| Affiliation |
BVDU Homoeopathic Medical College And Hospital Department Of Post Graduate And Research Centre |
| Address |
Bharati Vidyapeeth,(Deemed to be university)Homoeopathic medical college and homoeopathic hospital, Department of Postgraduate And Research centre, pune
Maharashtra ,411046
Pune
MAHARASHTRA
411043
India |
| Phone |
7767975231 |
| Fax |
|
| Email |
vaishnaviraut396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSAMIR S NADGAUDA |
| Designation |
PROFESSOR |
| Affiliation |
BVDU HOMOEOPATHIC MEDICAL COLLAGE AND HOSPITAL DEPARTMENT OF POST GRADUATE AND REASERCH CENTRE |
| Address |
BHARATI VIDYAPEETH (Deemed to be University),
HOMOEOPATHIC MEDICAL COLLEGE AND HOMOEOPATHIC
HOSPITAL, DEPT. OF POSTGRADUATE AND RESEARCH
CENTRE,
Pune
MAHARASHTRA
411043
Pune
MAHARASHTRA
411043
India |
| Phone |
9970153078 |
| Fax |
|
| Email |
sameer.nadgauda@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
VAISHNAVI RAUT |
| Designation |
PG RESIDENT |
| Affiliation |
BVDU Homoeopathic Medical College And Hospital Department Of Post Graduate And Research Centre |
| Address |
Bharati Vidyapeeth,(Deemed to be university)Homoeopathic medical college and homoeopathic hospital, Department of Postgraduate And Research centre, pune
Maharashtra ,411046
Pune
MAHARASHTRA
411043
India |
| Phone |
7767975231 |
| Fax |
|
| Email |
vaishnaviraut396@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVDU Homoeopathic Medical College And Hospital Department Of Post Graduate And Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi raut |
| Address |
Bharati Vidyapeeth,(Deemed to be university)Homoeopathic medical college and homoeopathic hospital, Department of Postgraduate And Research centre, pune
Maharashtra ,411046 |
| 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 VAISHNAVI RAUT |
BVDU Homoeopathic Medical College And Hospital Department Of Post Graduate And Research Centre |
Department Of Practice Of medicine Of Bharati Vidyapeeth(Deemed To be)Homoeopathic Medical College and Research centre. Bharati Education Campus Pune Satara road 411043
Pune
Maharashtra
Pune
MAHARASHTRA |
7767975231
vaishnaviraut396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati vidyapeeth(DTU) HMC, Pune |
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 |
constitutional homoeopathic remedy obtain only after repertrization. |
homoeopathic medicine will be prescribe at the beginning of the study and follow up will be taken after each month.
Potency will be select according to susceptibility of the patient. administration of the drug will be oral.
Total duration of intervention will be one year. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with gout having high serum uric acid level,2.both sexes and all age group,3.patient with history of clinical symptoms of acute gout,4.patient without any major systemic complication,5.family history of gout with recurrence, 6.patient complying for regular follow up,7.patient willing to participate in the the study and willing to sign the informed consent. |
|
| ExclusionCriteria |
| Details |
1.patient with severe and irreversible pathology,2.any other conditions requiring emergency or surgical interventions,3.pregnant and lactate women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the role of homoeopathic medicine in managing recurrence of acute
attacks in intercritical period of gout in one year.
|
To evaluate the role of homoeopathic medicine in managing recurrence of acute
attacks in intercritical period of gout in one year. follow up of case will be done on every one months after starting treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Individualised Homoeopathic medicine To Know possible effect on Reduce the hyperuricemia.
To Know possible effects on improve physical functional ability of patient. |
Hematological Examination(serum uric acid)Will be done before & after complition of study because To know effect of individualized homoeopathic medicine to Reduce the hyperuricemia. and
To improve physical functional ability of patient. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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="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
|
This is a clinical study to determine the effectiveness of Individualised homoeopathic medicine in the management of Intercritical period of gout in which the primary objective to evaluate the role of homoeopathic medicine in managing Reccurrence acute attacks in intercritical period of gout in one year. minimum 34 patient at Bharati Vidyapeeth (deemed to be university) homoeopathic medical college and hospital will be enrolled in the study. serum uric acid will be done before and after completion of study and each follow up will be taken after 1 month. |