| CTRI Number |
CTRI/2024/03/063748 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on fever using therapeutics of fever by H C Allen |
|
Scientific Title of Study
|
A clinical study on application of therapeutics of fever by H C Allen in management of pyrexia of unknown origin among paediatric age group |
| 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 Shalini N |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Sarada Krishna Homoeopathic medical college
Kulasekharam
Kanniyakumari
Department of Paediatrics
Kulasekharam
Kanniyakumari Kanniyakumari TAMIL NADU 629161 India |
| Phone |
6383466017 |
| Fax |
04651279448 |
| Email |
shalininallusamy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrBencitha Horrence Mary D |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Department of Paediatrics
Sarada Krishna Homoeopathic medical college
Kulasekharam
Kanniyakumari Kulasekharam
Kanniyakumari Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443064215 |
| Fax |
04651279448 |
| Email |
dr.bencitha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrBencitha Horrence Mary D |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Department of Paediatrics
Sarada Krishna Homoeopathic medical college
Kulasekharam
Kanniyakumari Kulasekharam
Kanniyakumari Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443064215 |
| Fax |
04651279448 |
| Email |
dr.bencitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic medical college |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic medical college |
| Address |
Department of Paediatrics
Kulasekharam
Kanniyakumari |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sarada Krishna homoeopathic medical college |
Department of Paediatrics
Sarada Krishna homoeopathic medical college
Kulasekharam
Kanniyakumari |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Shalini |
Sarada Krishna Homoeopathic medical college and hospital |
Department of Peadiatrics
Sarada Krishna Homoeopathic medical college
Kulasekharam
Kanniyakumari Kanniyakumari TAMIL NADU |
6383466017 04651279448 shalininallusamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada Krishna homoeopathic medical college Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children of both sexes with pyrexia of unknown origin with in age limit of 1 year to 18 years from Sarada Krishna homoeopathic medical college is taken using fever assessment scale |
|
| ExclusionCriteria |
| Details |
Children undertaking other system of medicine and with some other deep pathology is excluded
Children under 1 year and above 18 years are also excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients with pyrexia of unknown origin is taken using fever assessment scale and treatment with homoeopathic medicine after repertorization with Therapeutics of fever by H C Allen |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pyrexia of unknown origin is treated with homoeopathic medicine on repertorizing with therapeutics of fever by H C Allen |
1 year |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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 - NO
|
|
Brief Summary
|
Fever is a state
of elevated core temperature that is frequently, but not always, 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. Fever is one of the earliest clinical indications of disease in the
mammalian host and one of the leading causes of medical consultations globally.
The
endocrine, neurological, Immunological, and behavioral systems that control the
multi-systemic effects of the febrile response may be responsible for its
complexity. In addition to a controlled rise in body temperature, fever is also
accompanied by a variety of illness-related behaviors, modifications to the
physiological and metabolic makeup of many bodily systems, and changes to
immunological responses. Fever
of unknown origin (FUO) is defined as fever & more than 101 °C Lasting for
3 weeks or more for which no cause is apparent After 1 week of outpatient investigation.
A practical definition is fever & more than 101 °F measured on several
occasions over a 7-day period. Febrile illness in children is a major concern to the
parents and requires prompt intervention. The conventional treatment has ill
effects since it uses many drugs to treat the illness and it is also not favored
by the child. But homoeopathic management treats the same illness with a
single, minimal dose medicine and is also easily consumed by the child which
makes it children friendly. The purpose of this study is to effectively manage
pyrexia of unknown origin in children using therapeutics of fever by H.C.Allen. |