| CTRI Number |
CTRI/2024/07/070108 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to relieve the Symptoms of allergic rhinitis using constitutional medicine and assess the improvement using rhinitis control assessment test scale and absolute eosinophil count |
|
Scientific Title of Study
|
Effectiveness Of Homoeopathic Constitutional Medicine In Allergic Rhinitis By Assessing RCAT Scale And Absolute
Eosinophil Count- A Prospective Study |
| 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 PRIYADHARSHINI S |
| 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 TAMIL NADU 629161 India |
| Phone |
7397024787 |
| Fax |
|
| Email |
spriya200216@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M MURUGAN |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
IIIrd Floor, College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr M MURUGAN |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
IIIrd Floor, College Building, Department Of Organon Of Medicine, Sarada Krishna Homoeopathic Medical College,Kulasekharam
Kanniyakumari TAMIL NADU 629161 India |
| Phone |
9443343707 |
| Fax |
|
| Email |
drmmuruganhomoeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution -Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamil nadu, India, 629161
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Research Funded By College |
| Address |
Sarada Krishna Homoeopathic Medical College,Kulasekharam, Kanniyakumari District, Tamil nadu 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 PRIYADHARSHINI S |
Sarada Krishna Homoeopathic Medical College |
Room No 403 Department of Organon Of medicine and Homoeopathic Philosophy,Kulasekharam
Kanniyakumari, Tamil Nadu, 629161 Kanniyakumari TAMIL NADU |
7397024787
spriya200216@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College,Kulasekharam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J309||Allergic rhinitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medicine |
Individualised homoeopathic medicine will be given based on symptom similarity and considering the constitution of the patient The medicine will given for every 2 weeks |
| 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 allergic rhinitis.
Age group between 5 - 55 years.
Both sexes.
Patients without the complications of allergic rhinitis such as effusion formation in sinuses, edema of lids, cobble stone conjunctiva, serous otitis media, conductive hearing Loss, granular pharyngitis, bronchial asthma.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from other severe systemic diseases.
Cases in which surgical intervention becomes necessary.
Pregnant women or breast-feeding individuals may be excluded
Allergic rhinitis associated with any chronic and systemic disease on active treatment.
Exclude severe controlled diabetes.
Severe underlying medical conditions such as immunodeficiency disorders, autoimmune diseases or malignancies.
Patients with the complications of allergic rhinitis such as effusion formation in sinuses, edema of lids, cobble stone conjunctiva, serous otitis media, conductive hearing loss, granular pharyngitis, bronchial asthma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of symptoms of allergic rhinitis with constitutional homoeopathic medicine |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Symptomatic and general improvement in the condition of patients is evaluated using Rhinitis Control Assessment Test scale tool and Absolute Eosinophil Count.
|
6 MONTHS |
|
|
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)
|
15/07/2024 |
| 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 is the most common form of non-infectious rhinitis, affecting between
10% and 30% of all adults and as many as 40% of children. This will be treated by conventional treatments like, antihistamines, corticosteroids, Immunotherapy, Anti IgE antibody therapy and nasal decongestants. According to Dr.Hahnemann, In 5th aphorism,
he stated that chronic diseases has to be treated with constitutional medicine
in order to effect the cure and it should be based on the principles
of homoeopathy. According to 2nd aphorism, The cure must be
ideal, gentle and in rapid manner. Homoeopathy
acts in both ways, as effective in relieving symptoms and also increase one’s resistance to cold and
also strengthens the vital force and improve the quality of life.
Various research studies on allergic rhinitis have been conducted
previously and they were aimed at
determining the effectiveness of homoeopathic medicines in the treatment of allergic rhinitis based on
the assessment of Absolute eosinophil count and IgE levels. These studies focused
either on specific
medicines or on the Anti - miasmatic medicines. The results of these
studies were relied either on a particular assessment
scale or on a particular laboratory investigation. Thus, studies determining the efficacy of homoeopathic remedies
selected based upon the constitution of the patients
are less and if found are not recent. In addition to this, studies showing the simultaneous symptomatologic and lab parametric assessment of improvement in patients
with allergic rhinitis are insignificant. Hence, this research study will focus
on the effectiveness of homoeopathic constitutional medicine in allergic rhinitis
by assessing the symptomatologic RCAT scale and parametric improvement through Absolute Eosinophil Count. Improvement of the symptoms is assessed using Rhinitis
Control Assessment Test Scale. Absolute Eosinophil Count Result before
beginning of the treatment and after treatment is noted.
|