| CTRI Number |
CTRI/2025/02/080599 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Constitutional treatment of allergic rhinitis in homoeopathy |
|
Scientific Title of Study
|
A clinical Trial on the Efficacy of Aletris Farinosa in the Treatment of Leucorrhoea A single arm clinical Trial |
| 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 Anupama Kumari |
| Designation |
PG Scholar |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital |
| Address |
OPD-1-6 and PG Building RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
9681809567 |
| Fax |
|
| Email |
anupamanih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama kumari |
| Designation |
PG Scholar |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar |
| Address |
Room number 3 Department of Homoeopathic Materia Medica PG Block RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
9681809567 |
| Fax |
|
| Email |
anupamanih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indira Singh |
| Designation |
HOD Department of Homoeopathic Materia Medica |
| Affiliation |
RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar |
| Address |
Room number 3 Department of Homoeopathic Materia Medica PG Block RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar
Muzaffarpur
BIHAR
842002
India |
| Phone |
7739560242 |
| Fax |
|
| Email |
singh.katyayni@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Government Homoeopathic Medical College and Hospital Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Government Medical College and Hospital |
| Address |
Ramdayalu Nagar, Muzaffarpur, Bihar, 842002 |
| Type of Sponsor |
Government 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 Anupama kumari |
RBTS Government Medical College and Hospital, Muzaffarpur,Bihar, 842002 |
OPD-1,2,6 in Hospital building,Muzaffarpur, Bihar
Muzaffarpur
BIHAR |
9681809567
anupamanih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RBTS Government Medical College and Hospital-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: X31||Exposure to excessive natural cold, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medicine prescribed after analyzing the totality of symptoms |
After thoroughly analyzing the totality of symptoms I will prescribe a constitutional homoeopathic medicine in 30C 200C 1M as patient susceptibility for regular follow up 2weeks adhering strictly to the principles and guidelines of homoeopathy for the treatment of allergic rhinitis. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Symptomatic patient with positive findings of Allergic rhinitis.
Cases belonging to both sexes.
Age group: Between 08-50 years of age.
Patient willing to give consent to take part in the study |
|
| ExclusionCriteria |
| Details |
Patients below the age of 08 years.
Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness.
Substance abuse and/or dependence like addiction to tobacco, alcohol, smoking.
Pregnant and lactating women.
Patients with co-morbidity-systemic illness or other illness affecting quality of life.
Patients unwilling to participate in this research. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected from the study that it will improve the individualized remedies for allergic rhinitis to ensure holistic and lasting relief by addressing unique symptoms, improving overall health, resolving miasmatic tendencies, and preventing recurrence and will provide a good alternative to the conventional mode of treatment with no side effect. |
Assesment at baseline with regular intervals 2 weeks till 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To know the importance of individualized remedies indicating symptoms of allergic rhinitis.
To use a scoring system to assess the quality of life in allergic rhinitis.
To compare the symptomatic changes of patients before and after Homoeopathic treatment. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/02/2025 |
| 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 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 an atopic condition marked by inflammation of the nasal lining, leading to typical symptoms like nasal blockage, itching, a runny nose, and sneezing. The purpose of this study is to investigate the efficacy of homoeopathic treatment for allergic rhinitis. This is accomplished by a detailed history of the patient’s assessment of the treatment in terms of the types of symptoms, the time, duration, and frequency of symptoms, suspected exposures, exacerbating/alleviating factors, and seasonality of their allergic rhinitis attacks over time. A careful review of the available Homoeopathic literature, as well as an exhaustive search, found a scarcity of original scientific work on related topics in homoeopathy to date. So, there is room for improvement. The purpose of this research is to assess the efficacy of homeopathic individualized medicine in treating allergic rhinitis, as well as to evaluate the effects on quality of life.
|