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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  
Status 
Not Applicable 
 
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.

 
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