| 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
|
|
|
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
|
|
|
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. |