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CTRI Number  CTRI/2024/06/069309 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic management of allergic rhinitis 
Scientific Title of Study   A prospective study on the homoeopathic management of perennial allergic rhinitis using Kent’s series in degrees. 
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 KEERTHANA SHAJI 
Designation  PG SCHOLAR 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor,College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9061030073  
Fax    
Email  kshaji27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr MANOJ NARAYAN V  
Designation  PROFESSOR 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor,College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr MANOJ NARAYAN V  
Designation  PROFESSOR 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  IIIrd Floor,College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamilnadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9995114518  
Fax    
Email  manojnarayanv@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTION - Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamilnadu,India, 629161 
 
Primary Sponsor  
Name  Post Graduate Research Funded By College 
Address  Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamilnadu 629161 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KEERTHANA SHAJI  Sarada Krishna Homoeopathic Medical College  Opd,Ipd,Rural Health Centres Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari,Tamil Nadu,629161
Kanniyakumari
TAMIL NADU 
9061030073

kshaji27@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J308||Other allergic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicine  Case taking, selection and administration of medicine will be based on Homoeopathic principles. Selection of potency is based on homeopathic principles and susceptibility of the patient. Repetition and further follow up is based on Kent’s series in degrees. Pre and post assessment will be done by using Rhinitis Control Assessment Test on every follow up. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients having symptomatology of perennial allergic rhinitis.
Age group between 5-55 years.
Both sexes.
All types of socio - economic status. 
 
ExclusionCriteria 
Details  Patients below 5years and above 55 years of age.
Patients suffering from other severe systemic illness.
Cases in which surgical intervention becomes necessary.
Pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of Homoeopathic similimum based on Kent’s series in degrees.  6 MONTHS  
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic & general improvement in patients condition is evaluated according to Rhinitis Control Assessment Scale.  Once in two weeks 
 
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)   01/07/2024 
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  

Allergic rhinitis has an unquestionable impact on quality of life, including the limitations on everyday activities and decreased productivity at work and school. On consideration of the adverse effects of allergic rhinitis on function and capacity, it is evident that medical treatment for allergic rhinitis should address issues beyond clinical outcome measures. One of the chief goals of the treatment is to improve patients’ well-being and their ability to function. Treatment modalities should not only provide optimum clinical benefits; they should also increase the patient satisfaction.

The current focus of the study is to manage perennial allergic rhinitis using Homoeopathic medicines. Allergic rhinitis has become more prevalent these days. The chances of occurrence and persistence of the disease is increasing. Kent has explained about the series of degrees in his lesser writings. According to Kent when the similimum is found, the remedy will act curatively in a series of potencies. Kent says that whatever potency a physician uses, that one potency is not sufficient for chronic diseases, which will generally do for acute diseases. After long observation in the range of potencies, Kent has settled upon the octaves in the series of degrees as – 30th, 200th, 1M, 10M,50M, CM, DM and MM. In lesser writings of Kent, it is mentioned that many of his patient’s records indicate that the patient has steadily improved after each potency, to the highest, with symptoms becoming fainter, and he himself growing, mentally and physically. Hence homoeopathic medicines given in ascending centesimal potencies using Kent’s series in degrees can effectively prevent the recurrence, the risk of complications and improve the quality of life of patients with perennial allergic rhinitis. Improvement of the symptoms is assessed using Rhinitis Control Assessment Scale.


 
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