| CTRI Number |
CTRI/2024/03/063502 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the comparative effect of Constitutional Homoeopathic Medicine and Histaminum Hydrochlorinum (Homoeopathic Medicine) in cases of Allergic Rhinitis |
|
Scientific Title of Study
|
Role of Histaminum Hydrochlorinum V/S Constitutional Medicine in Cases of Allergic Rhinitis-A Randomized controlled single Blind clinical trail |
| 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 vani oza |
| Designation |
Associate Professor/Phd scholar |
| Affiliation |
Rajkot Homoeopathic Medical college /Parul university |
| Address |
Rajkot Homoeopathic Medical college,Behind Jaynath Petrol Pump, Makkam Chowk Department Of Homoeopathic Materia Medica (PG),Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
09428052673 |
| Fax |
|
| Email |
vanioza8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankit Dubey |
| Designation |
Principal and HOD |
| Affiliation |
Homeopathic Medical college and Hospital Chandigarh |
| Address |
Homoeopathic Medical College and Hospital, M-671, Sukhna Path, Sector 26,Chandigarh, Department of Homoeopathic Materia Medica
Chandigarh
CHANDIGARH
160019
India |
| Phone |
9882244568 |
| Fax |
|
| Email |
doctorankit79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr vani oza |
| Designation |
Associate Professor/Ph.d scholer |
| Affiliation |
Rajkot Homoeopathic Medical college/Parul University |
| Address |
Rajkot Homoeopathic Medical College,Behind Jaynath Petrol Pump,Makkam Chowk, Department of Materia Medica (PG),Rajkot
Rajkot Homoeopathic Medical College,Behind Jaynath Petrol Pump,Makkam Chowk,Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
94280526733 |
| Fax |
|
| Email |
vanioza8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sainath Homoepathic Medical College attached with Rajkot Homoeopathic Medical college |
|
|
Primary Sponsor
|
| Name |
dr. vani oza |
| Address |
14, samanvay society, Raiya Road, Rajkot |
| 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 vani oza |
sainath Homoeopathic Hospital |
Makkam chowk, Behind jainath petrol pump, Homoeopathic Department,Rajkot
Rajkot
GUJARAT |
09428052673
vanioza8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee For Human Research- Rajkot Homoeopathic Medical College, Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J30||Vasomotor and allergic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A(controlled Group)-
Histaminum Hydrochlorinum in 30 potency will be given |
study duration -1 to 1.6 years year
- Histaminum Hydrochlorinum 30 will be given whenever we are having symptoms of Allergic Rhinitis
Dose , potency and repetation-
Medicine will be given in 30 potency whenever we find the acute episode of AR
Doses and repetation will be modified according to need of the case
Plan of treatment-
this group will be receive only Histaminum Hydrochlorinum
There will not be any interference of any medicine (constitutional /therapeutic/nosode) as an acute or chronic Medicine
Follow up –
Patient will be call for follow up at every 15 days
The patient will be come for follow up before 15 days n if it will be required , as in acute attack. Assesment will done after 6 month
|
| Intervention |
Group B(experimental Group)-
will have Homoeopathic Constitutional Medicine in potency whichever will be needed according to suceptibility of patient |
study duration - approximately 1 to 1.6 years
this group will receive Homoeopathic constitutional medicine
Selection of Remedy-
Constitutional Medicine will be given to this group
The Medicine will be selected by forming appropriate Totality and repertorising the case and finally with the help of Materia Medica
Dose , potency and repetation-
It will be select accoording to requirement of case with the help of posology according to Organon of Medicine
Plan of treatment-
this group will be receive only constitutional Medicine in Acute as well as Chronic condition
There will not be any interference of any other medicine (acute /therapeutic/nosode) as an acute or chronic Medicine
Follow up –
Patient will be call for follow up at every 15 days
The patient will be come for follow up before 15 days n if it will be required , as in acute attack . Assessment will be done after 6 month
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
48.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosed (with the help of Clinical symptoms/ Clinical Investigation/ Score for Allergic Rhinitis (SFAR)) and pre-Diagnosed cases of Allergic Rhinitis
2)Diagnosed cases of allergic rhinitis taking treatment from another system having no relief and seeking Homoeopathic treatment will also includes
3)Follow up criteria-
Patient with minimum 6 Month follow ups
Minimum 6 follow ups at an interval of 15 days , before or after as per the need of case
|
|
| ExclusionCriteria |
| Details |
• Patient is associate with any Pathological condition
• Allergic Rhinitis Associated with Asthma will be excluded
• End stage diseases like cancer etc..
• Immunocompromised diseases like HIV etc..
• Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study the effectiveness of Constitutional Homoeopathic medicines in comparison to Histaminum Hydrochlorinum in cases of Allergic Rhinitis. |
1 year 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of Constitutional Homoeopathic Medicine with the help of JRQLQ scale in Allergic Rhinitis cases
To study the effect of Histaminum Hydrochlorinum in Allergic Rhinitis with the help of JRQLQ scale
|
after intervention of 6 month in each patient in both group with japanease rhinoconjuctivitis quolity of life questionar(JRQLQ) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
12/03/2024 |
| 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="6"
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
|
AlAllergic rhinitis represents a global health concern where it affects approximately 400 million people worldwide. The prevalence of AR has increased over the years along with increased urbanization and environmental pollutants thought to be some of the leading causes of the disease. It is the 6th most common disease word wide. Allergic Rhinitis causes running Nose , Headache , Itching , Heaviness of head.In study the sample size will be 120 . 60 patient will be allocated in Group A who will be received Hystaminum Hydrochlorinum 30 and 60 patient will be allocated in Group B who will be received Constitutional medicine . Final assessment of each patient will done after 6 month of intervention with JRQLQ. total study duration is 1 year and 6 month |