| CTRI Number |
CTRI/2024/08/072990 [Registered on: 27/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Importance of Complete Repertory
and Boenninghausen Boger Final General Repertory in Managing the Serum Uric Acid Level.
|
|
Scientific Title of Study
|
A Comparative study on the Effectiveness of Complete Repertory
and Boenninghausen Boger Final General Repertory in the
Management Of Serum Uric Acid Level. |
| 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 Selvakannan S |
| Designation |
PG SCHOLAR |
| Affiliation |
Sarada Krishna homoeopathic medical college |
| Address |
Room No:301, Department of Repertory, Sarada Krishna homoeopathic medical college, Kulasekharam, Kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9629488984 |
| Fax |
|
| Email |
drselvakannan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sathish Kumar V |
| Designation |
Professor and HOD |
| Affiliation |
Sarada Krishna homoeopathic medical college |
| Address |
Room no:301, Department of Repertory, Sarada Krishna homoeopathic medical college, Kulasekharam, Kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443558483 |
| Fax |
|
| Email |
hodcr@skhmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathish Kumar V |
| Designation |
Professor and HOD |
| Affiliation |
Sarada Krishna homoeopathic medical college |
| Address |
Room no:301, Department of Repertory, Sarada Krishna homoeopathic medical college, Kulasekharam, Kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443558483 |
| Fax |
|
| Email |
hodcr@skhmc.org |
|
|
Source of Monetary or Material Support
|
| Institution - Sarada Krishna Homoeopathic Medical college, Kulasekharam, Kanniyakumari, Tamil Nadu 629161 |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna homoeopathic medical college |
| Address |
Sarada Krishna homoeopathic medical college,
Kulasekharam,
Kanniyakumari,
Tamilnadu - 629161 |
| 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 Selva Kannan |
Sarada Krishna Homoeopathic Medical College |
Room No 301, Department of Repertory, Kulasekharam, Kanniyakumari,
Tamil Nadu 629161
Kanniyakumari
TAMIL NADU |
9629488984
drselvakannan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medicine similar to symptomatology of the case |
Medicines will be selected based on case taking and repertorisation using Complete repertory.
Follow up is taken 15 days once and medicine is repeated 2 times a day. The minimum dosage will be given as per the directions given in the 6th
edition of Organon of medicine. The medicine is administered orally |
| Comparator Agent |
Medicine will be selected BOENNINGHAUSEN BOGER FINAL GENERAL REPERTORY |
Medicines will be selected based on case taking and repertorisation using Boenninghausen Boger Final General Repertory.
Follow up is taken 15 days once and medicine is repeated 2 times a day. The minimum dosage will be given as per the directions given in the 6th
edition of Organon of medicine. The medicine is administered orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient within age group of 18-60 years.
Both sexes.
Cases that are indicated with serum uric acid level more than the normal limit. |
|
| ExclusionCriteria |
| Details |
Patients with advanced stage of gout and associated other comorbidities like AKI,
rheumatic disorders.
Cases with other auto immune disease. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment in changes in serum uric acid levels after administration of homoeopathic
medicines. |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A decrease in severity of symptom will serve as a means for assessing progress.
|
6 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/09/2024 |
| 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="2"
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 - NO
|
|
Brief Summary
|
The role of homoeopathy in treating hyperuricemia and its associated
complication with help of complete repertory and Boenninghausen Boger final
general repertory as an aid for selection of homoeopathic remedies in
management of serum uric acid level by comparing the before and after values of
serum uric acid level. 40 cases presenting with symptoms increased serum uric
acid level like Gout, kidney stones and other related conditions from the OPD,
IPD and peripheral centres of Sarada Krishna Homoeopathic Medical College will
be taken. Patient will be selected on the basis of inclusion and exclusion
criteria. Detailed case taking will be done and recorded in Sarada Krishna
Homoeopathic Medical College standardized chronic case record format. Clinical
diagnosis will be made on the basis of complete symptomatology along with
necessary investigations. Serum uric acid level will be noted prior to the
treatment. Medicinal selection will be made based on the repertorisation of 20
case done by using complete repertory and 20 cases done by Boenninghausen Boger
final general repertory then finally co relating with Materia Medica. Changes
in serum uric acid levels will be noted in the subsequent follow ups (15 days
once). Also the Clinical Symptoms will be evaluated, before and after will be
subjected to statistical analysis and presented. |