| CTRI Number |
CTRI/2024/07/070053 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A comparative study on different doses and medicines used in treating fevers in homoeopathy |
|
Scientific Title of Study
|
Analytical study of centesimal scale potencies in managing acute febrile illness in paediatric cases |
| 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 Robin K James |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
409 room number, 3rd floor college building, department of paediatrics, Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari, Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8943726993 |
| Fax |
|
| Email |
drrobinkjames@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P R SISIR |
| Designation |
Professor and HOD |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
409 room number, 3rd floor college building, department of paediatrics, Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari, Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
6282615250 |
| Fax |
|
| Email |
hodpd@skhmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr P R SISIR |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
409 room number, 3rd floor college building, department of paediatrics, Sarada krishna homoeopathic medical college, Kulasekharam, Kanniyakumari, Tamilnadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
6282615250 |
| Fax |
|
| Email |
hodpd@skhmc.org |
|
|
Source of Monetary or Material Support
|
| Institution - Sarada Krishna homoeopathic medical college, Kulasekharam, Kanniyakumari, Tamilnadu, India. PIN - 629161 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Research funded by College |
| Address |
Sarada krishna homoeopathic medical college, kulasekharam, kanniyakumari district, tamilnadu, India. PIN - 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 Robin k james |
Sarada Krishna homoeopathic medical college |
Room No 106, 5B Unit-Paediatrics Out patient department and Inpatient department of paediatrics, Sarada Krishna homoeopathic medical college, kulashekaram, kanniyakumari district
Kanniyakumari
TAMIL NADU |
8943726993
drrobinkjames@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: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
Dose- selected based on homoeopathic principles
Frequency - selected based on susceptibility of the patient
Route of administration - Orally
Regular follow up maintained till the patient gets relieved |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Age groups - 1 to 18 years
Both male and female
Temperature range : 99 to 103F
|
|
| ExclusionCriteria |
| Details |
Complicated fevers
Fever with temperature more than 103 F
Hyperpyrexia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A decrease in severity of symptoms and temperature will serve as a means for assessing progress |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Most effective drugs in treating fevers in homoeopathy |
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| 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 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
|
Fever is defined as
the elevation of core temperature above normal (36.60C to 370C),
which is a component of the defensive
responses of multicellular organisms (host) to the invasion of live
(microorganisms) or inanimate matter recognized as pathogenic or alien by the
host. This definition highlights the adaptive nature of the febrile response. This
study is to find the effectiveness of various potencies in centesimal scale in treating fever. |