| CTRI Number |
CTRI/2024/12/077830 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Ambrosia artemisiaefolia and Individualized Homoeopathic Medicine in management of allergic rhinitis |
|
Scientific Title of Study
|
ASSESSING THE EFFECT OF AMBROSIA ARTEMISIAEFOLIA AND INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF ALLERGIC RHINITIS IN ADULT POPULATION: A COMPARATIVE RANDOMIZED CLINICAL STUDY
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhavana Sengar |
| Designation |
Pg scholar |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Department of homoeopathic materia medica
second floor
room no S1
Bakson homoeopathic medical college and hospital
36 B
Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9044823527 |
| Fax |
|
| Email |
b.sengar7751@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Nair |
| Designation |
HOD, Pg incharge & Guide |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Department of homoeopathic materia medica
second floor
room no S1
Bakson homoeopathic medical college and hospital
36 B
Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Nair |
| Designation |
HOD, Pg incharge & Guide |
| Affiliation |
Bakson homoeopathic medical college and hospital |
| Address |
Department of homoeopathic materia medica
second floor
room no S1
Bakson homoeopathic medical college and hospital
36 B
Knowledge Park I
Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
9990178024 |
| Fax |
|
| Email |
pginchargebakson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
phase 1 knowledge park, greater Noida, UP
201310
India |
|
|
Primary Sponsor
|
| Name |
Principal Bakson Homoeopathic medical college and hospital |
| Address |
Ground floor room no. G22
Bakson homoeopathic medical college and hospital
B36 Knowledge park 1
Greater Noida
Uttar Pradesh
201310 |
| 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 |
| DrBhavana Sengar |
Bakson homoeopathic medical college and hospital |
Peripheral out patient department(POPD)
Bakson homoeopathic medical college and hospital
B36 Knowledge park 1
Greater Noida
Uttar Pradesh
201310
Gautam Buddha Nagar
UTTAR PRADESH |
09044823527
b.sengar7751@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bakson Institutional Ethics Committee |
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 |
| Comparator Agent |
Ambrosia artemesiaefolia |
Pill form, 30 pill size, oral route of administration, centesimal potency, first dose at the time of case taking subsequent doses according to follow ups |
| Intervention |
Individualized homoeopathic medicines |
Pill form, 30 pill size, oral route of administration ,centesimal potency, first dose at the time of case taking subsequent doses according to follow ups |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed participants(new and old) of Allergic Rhinitis.
Participants from 20–59 years age group, both male and female.
Participants who had taken any Anti – allergic medicines for Allergic Rhinitis willing to have homoeopathic treatment will be enrolled after washout period of 2 weeks.
New cases of allergic rhinitis will be diagnosed by clinical and physical examination . |
|
| ExclusionCriteria |
| Details |
Participants with other Upper respiratory tract infection (Laryngitis, Pharyngitis, Diphtheria, Etc.)
Participants with Lower respiratory tract infection (Chronic bronchitis, Bronchial Asthma, Pulmonary Tuberculosis)
Gross nasal developmental defects or structural abnormalities causing obstruction, e.g., nasal polyp(s), deviated septum etc.
Participants on steroid treatment.
Pregnant and Lactating females.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in TNSS Scale to signify improvement in Allergic Rhinitis. |
TNSS Scale will be used at baseline, every 4 weeks upto 24 weeks.
15 month study.
6 months enrolment
6 months follow up
3months analysis
first dose at the time of case taking and subsequent doses according to follow ups.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
16/12/2024 |
| 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="3"
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
|
This is a randomized comparative parallel arm study, to compare the effect of Ambrosia and individualized homoeopathic medicines in the management of Allergic Rhinitis by using TNSS scale. The primary outcome is to assess the change in TNSS scale in both groups at baseline and after treatment period of 6 months. |