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CTRI Number  CTRI/2022/04/041644 [Registered on: 05/04/2022] Trial Registered Prospectively
Last Modified On: 01/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A STUDY ON HOMOEOPATHIC MANAGEMENT OF ALLERGIC COLD 
Scientific Title of Study   A PROSPECTIVE CLINICAL STUDY OF ALLERGIC RHINITIS AND ITS HOMOEOPATHIC MANAGEMENT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ANAND A KULKARNI 
Designation  PG Student 
Affiliation  Dr D Y Patil Homoeopathic Medical College & Hospital Pimpri Pune 
Address  Department of Organon of Medicine & Homoeopathic Philosophy Dr D Y Patil Homoeopathic Medical college and Hospital Pimpri Pune Maharastra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9845643211  
Fax    
Email  dranandkulkarni@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dharmendra B Sharma 
Designation  Principal & Dean 
Affiliation  Dr D Y Patil Homoeopathic Medical college and Hospital Pimpri Pune 
Address  Department of Organon of Medicine & Homoeopathic Philosophy Dr D Y Patil Homoeopathic Medical college and Hospital Pimpri Pune Maharastra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone    
Fax    
Email  info.homoeopathy@dypvp.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dharmendra B Sharma 
Designation  Principal & Dean 
Affiliation  Dr D Y Patil Homoeopathic Medical college and Hospital Pimpri Pune 
Address  Department of Organon of Medicine & Homoeopathic Philosophy Dr D Y Patil Homoeopathic Medical college and Hospital Pimpri Pune Maharastra 411018 India

Pune
MAHARASHTRA
411018
India 
Phone    
Fax    
Email  info.homoeopathy@dypvp.edu.in  
 
Source of Monetary or Material Support  
Dr. B.D. Jatti Homoeopathic Medical College & Hospital, Dharwad  
Dr. D. Y. Patil Homoeopathic Medical College & Hospital, Pimpri, Pune 
 
Primary Sponsor  
Name  Dr Anand A Kulkarni 
Address  Bhavani Nagar Saraswathpur Dharwad 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand A Kulkarni  Dr B D Jatti Homoeopathic Medical College Hospital and PG Research Centre Dharwad  OPD and IPD Department of Organon of Medicine & Homoeopathic Philosophy Dr B D Jatti Homoeopathic Medical College Hospital Dharwad 580001 Karnataka
Dharwad
KARNATAKA 
9845643211

dranandkulkarni@gmail.com 
Dr Anand A Kulkarni  Dr. D. Y. Patil Homoeopathic Medical College & Hospital, Pimpri, Pune.  OPD and IPD Department of Organon of Medicine & Homoeopathic Philosophy Dr. D. Y. Patil Homoeopathic Medical College & Hospital, Pimpri, Pune.
Pune
MAHARASHTRA 
9845643211

dranandkulkarni@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
D Y Patil Homoeopathic Medical College, Hospital. Pune  Approved 
Dr B D Jatti Homoeopathic Medical College Hospital and Post Graduate Research Centre Dharwad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine  According to the individulization which is more similar is selected and appropriate potency is prescribed. Follow ups would be watched & analyzed as per the criteria setup in each case  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Subjects of all age groups and both sex.
2 Subjects irrespective of their occupation and socio-economic status will be selected.
3 Subjects diagnosed as cases of allergic rhinitis covering clinical features and h/o paroxysmal attack and showing raised Absolute Eosinophil Count ie more than 440cells/cmm and more than 3 eosinophils in nasal secretion.
4 Subjects who have given consent for the study
 
 
ExclusionCriteria 
Details  1 Subjects with any other chronic diseases and on active treatment.
2 Subjects with any anatomical or pathological irreversible structural changes.
3 Complications of allergic rhinitis like sinusitis, nasal polypi, serous otitis media, orthodontic problems, bronchial asthma
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The progress of the treatment of patient shall be assessed as per the guidelines given in the Organon for each individual class of case.
Recovered: Disappearance of all the presenting complaints that formed the portrait of the disease and normal level of eosinophil count i.e. less than 440 cells/cmm and no eosinophil seen in nasal secretion along with general well-being of the patient.
Improved: Partial relief of some of the presenting complaints that formed the portrait of the disease with / without relief of clinical features of allergic rhinitis but relapsing of signs and symptoms, decreased in eosinophil count but not restore to normal i.e. more than 440 cells/cmm and eosinophils seen in nasal secretion general well-being of the patient.
Not Improved: No relief from symptoms and no changes in Absolute Eosinophil Count in both blood and nasal secretion even after sufficient period of treatment, whatsoever.
 
12 months 
 
Secondary Outcome  
Outcome  TimePoints 
The progress of the treatment of patient shall be assessed as per the guidelines given in the Organon for each individual class of case.
Recovered: Disappearance of all the presenting complaints that formed the portrait of the disease and normal level of eosinophil count i.e. less than 440 cells/cmm and no eosinophil seen in nasal secretion along with general well-being of the patient.
Improved: Partial relief of some of the presenting complaints that formed the portrait of the disease with / without relief of clinical features of allergic rhinitis but relapsing of signs and symptoms, decreased in eosinophil count but not restore to normal i.e. more than 440 cells/cmm and eosinophils seen in nasal secretion general well-being of the patient.
Not Improved: No relief from symptoms and no changes in Absolute Eosinophil Count in both blood and nasal secretion even after sufficient period of treatment, whatsoever.
 
24 months 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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 4 
Date of First Enrollment (India)   11/04/2022 
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   NIL 
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 commonest allergy encountered in clinical practice and constitutes more than 50% of all allergies seen in India. In fact, 1 in 6 people suffer from rhinitis which makes it’s the commonest chronic disease of man today, and even now its incidence is steadily increasing. Nasal symptoms are often deemed, however, their prevalence and effect on the quality of life, justify an aggressive but rational approach. It must also be acknowledged that rhinitis appears first in about 45% of patients. Besides, it is now well documented that adequate nasal treatment can improve pulmonary functions. The incidence of allergic disease has dramatically increased all over the world over recent decades. Although childhood hay fever tends to be more common, this condition can occur at any age and usually occurs after years of repeated inhalation of allergic substances.

Homoeopathy has a significant role in the treatment of allergic rhinitis. The properly taken detailed case history, concept of susceptibility, individualisation helps in treating allergic rhinitis. Homoeopathic medicines work by optimising the overactive immune system. Homoeopathic medicines provide a stimulus to the body like that of the trigger or allergen leading to the gradual desensitization of the immune system.

Clinical Types:

1) Seasonal: Hay fever due to pollen grains occurs at the time of pollination.

2) Perennial: Affects the patient throughout the year.

Symptoms:

1.    Irritation in the nose is the initial symptom.

2.    Paroxysmal sneezing of recurrent type is usually present which exhausts the patient. In chronic cases sneezing may be less.

3.    Rhinorrhoea is watery and copious.

4.    Nasal obstruction due to venous stasis is often present.

5.    Anosmia may be present intermittently or continually.

6.    Headache can be present.

 Signs:

1.    Acute Stage: The mucosa appears to be pale with excessive mucoid or watery secretions.

2.    Chronic Stage-The nose may appear to be normal or the mucosa is bluish or purplish due to venous stasis.

3.    Infection may be superimposed.

4.    Polyps may be present.

5.    Allergic Salute-Itching in the nose and rhinorrhoea may lead the patient to lift the tip of his nose upwards with his palm which appear like a salute.

6.    Darrires line- Repeated allergic salute may result in a horizontal crease on the dorsum of the nose a little superior to the tip of the nose.

Diagnosis:

It consists of diagnosing allergic rhinitis and detecting the allergen.

1) Diagnosing Allergic Rhinitis:

i) Clinical features and the paroxysmal attacks reveal the diagnosis.

ii) Nasal secretions may contain eosinophils.3

Cytological examination of swab taken from the mucous membrane of inferior turbinate reveals that many patients have marked eosinophilia, i.e. eosinophils accounting for more than half of the aggregate number of blood cells.As rare (0-3 whole slide), moderate(0-3hpf), or many (more than 3hpf).

iii) Haemogram may show eosinophilia. i.e. more than 440cells/cmm

iv) Stools are examined to exclude helminths.

2) Detection of Allergens

It is not possible to detect the allergen in all the cases as it is impossible to test against all the allergens because a person may be allergic to multiple allergens. Following tests are useful.

a)     History may suggest the nature of allergy.

b)     Skin tests by intradermal injections.

c)      Inhalation of allergens- Nasal provocation tests.

d)     Elimination tests for food.

RAST (Radio allegro sorbent test) is a new sensitive in vitro test for the assay of reaginic (IgE) antibodies specific for particular antigens.

Complications:

Nasal allergy may cause:-

1) Recurrent sinusitis because of obstruction to the sinus ostia.

2) Nasal Polypi.

3) Serous otitis media.

4) Orthodontic problems and other ill-effects of prolonged mouth breathing especially in children.

Bronchial asthma- Patients of nasal allergy have four times more risk of developing bronchial asthma.

Treatment:

Avoiding the allergen or desensitisation against the allergen is the ideal treatment, but it is not always possible.

1) Avoidance of the allergen is ideal but is not always practical

2) Desensitisation

3) Symptomatic

General-Vitamin C and calcium are often recommended but are of doubtful value.

    Allopathic treatment can provide only temporary relief to allergic conditions and the patient suffers time and again from the symptoms whenever exposed to the triggers. Whereas, homoeopathic treatment has proven to cure the problem from the roots, by strengthening body’s own immune system.

  Homoeopathy is safe, effective system of natural healing that is based on the principal that “like cures like” when it comes to allergic rhinitis, Homoeopathic treatment boosts a person’s immune system and eliminates their propensity for hay fever and allergies. Homoeopathy is very effective in managing all the symptoms of allergies and also plays an important role in preventing relapse of the condition and improving the general health of the person.

   Hence, taking all these factors into consideration it is a sincere effort to study the role of homoeopathic medicines in treatment of allergic rhinitis.

 
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