| CTRI Number |
CTRI/2024/05/066773 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of Individualised homoeopathic medicine and Histaminum in patients of Allergic rhinitis |
|
Scientific Title of Study
|
A Randomised double arm parallel clinical study to compare effectiveness of Individualised homoeopathic medicine versus Histaminum in the management of allergic rhinitis |
| 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 Subhi Jain |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Materia Medica department,2nd floor,room no. 2,Nehru Homoeopathic Medical College and Hospital B Block Defence colony New Delhi
South
DELHI
110024
India |
| Phone |
9179590029 |
| Fax |
|
| Email |
subhijain10july@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Thankaraj |
| Designation |
Professor |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Surgery department,1st floor, room no.4,Nehru Homoeopathic Medical College and Hospital B Block Defence colony New Delhi
South
DELHI
110024
India |
| Phone |
9868396618 |
| Fax |
|
| Email |
drthankaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Subhi Jain |
| Designation |
Junior Resident |
| Affiliation |
Nehru Homoeopathic Medical College and Hospital |
| Address |
Materia Medica department 2nd floor,room no.2 ,Nehru Homoeopathic Medical College and Hospital B Block Defence colony New Delhi
South
DELHI
110024
India |
| Phone |
9179590029 |
| Fax |
|
| Email |
subhijain10july@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patients and in patients department of nehru homoeopthic medical College and hospital |
|
|
Primary Sponsor
|
| Name |
DR Subhi Jain |
| Address |
Nehru Homoeopathic Medical College and Hospital B Block Defence colony New Delhi |
| Type of Sponsor |
Other [Self ] |
|
|
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 Subhi Jain |
OPD -5, Respiratory project,Nehru Homoeopathic Medical College and Hospital |
Nehru Homoeopathic Medical College and Hospital B Block Defence colony New Delhi 110024
South
DELHI |
9179590029
subhijain10july@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committe NHMC |
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 |
Histaminum |
patient will be given Histaminum in the desirable Potency as per the randomization sequence. |
| Intervention |
Individualised homoeopathic medicine |
Intervention: Intervention
planned as after obtaining
consent and asked all the
questions of standardised case
taking Performa, medicine will
be prescribed which to be taken in oral route, dose and repetition of which will depend upon the susceptibility of the patients. If the condition improves, the
dose of the medicine will be
reduced gradually. All medicines will be procured from Good Manufacturing practice (GMP) certified firm. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical signs and symptoms of Allergic Rhinitis as per ICD 10 classification J30.411
Pre diagnosed cases of Allergic Rhinitis.
Patients who have not taken any treatment since last 1 week for Allergic Rhinitis .
Patients willing to take homoeopathic treatment
Patients giving informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with serious complications and other uncontrolled or life-threatening systemic illness.
Case of Nasal Polyp ,Deviated Nasal Septum ,Sinusitis, Allergic Bronchitis , Asthma or other Respiratory illness resembling allergic rhinitis
Diagnosed cases of Psychiatric illness.
Pregnant women and Lactating mothers.
Substance abuse/ Dependence.
Patients who are not willing to be a part of this study.
Self-reported Immunocompromised state |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total symptoms score |
2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TOTAL SYMPTOM SCORE |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study will be a Prospective, Double arm parallel group, open label, randomized clinical study to assess the effectiveness of individualized homoeopathic medicine in the treatment of allergic rhinitis. Patients will be randomly allocated in 1:1 ratio by using computerized Block Randomization into 2 groups: individualized homoeopathic medicine treatment group and HISTAMINUM treatment group. Hypothesis depends upon any significant difference between the two comparable groups i.e. Group A is Individualized homoeopathic Medicine and Group B is Histaminum in treatment of Allergic Rhinitis. Final evaluation of results will be assessed on the basis of improvement in symptoms as well as by using TSS Score. Follow up of cases will be depending upon the severity of the symptoms, and as per the need and the necessity of the case preferably fortnightly. Study duration is one year, 60 patients are included in the study patients are followed every 2 weeks (next 4 weeks) up to 6 months the outcomes are measured every 4 weeks up to 24 weeks. |