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CTRI Number  CTRI/2025/07/091368 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Usefulness Of Smelling Medicines Through The Nose Works During An Asthma Attack 
Scientific Title of Study   Efficacy Of Olfactory Route In Cases Of Acute Exacerbation Of Asthma 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Desai Jahanvi Pankajkumar  
Designation  PG SCHOLAR 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital Surat Gujarat India 
Address  Chandravatiben Dhansukhlal Pachchigar College Of Homoeopathic Medicine And Hospital Post Graduation Devision Department of Homoeopathic Pharmacy 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India 395001

Surat
GUJARAT
395001
India 
Phone  9099925084  
Fax    
Email  jahanvidesai5200@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Freny Randeria 
Designation  Assistant Professor(Department Of Homoeopathic Pharmacy) 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital Surat Gujarat India 
Address  Chandravatiben Dhansukhlal Pachchigar College Of Homoeopathic Medicine And Hospital Post Graduation Devision Department of Homoeopathic Pharmacy 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India 395001

Surat
GUJARAT
395001
India 
Phone  8980103069  
Fax    
Email  frenyranderia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Freny Randeria 
Designation  Assistant Professor(Department Of Homoeopathic Pharmacy) 
Affiliation  C D Pachchigar College of Homoeopathic Medicine And Hospital Surat Gujarat India 
Address  Chandravatiben Dhansukhlal Pachchigar College Of Homoeopathic Medicine And Hospital Post Graduation Devision Department of Homoeopathic Pharmacy 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India 395001

Surat
GUJARAT
395001
India 
Phone  8980103069  
Fax    
Email  frenyranderia@gmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 395001 
 
Primary Sponsor  
Name  C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India  
Address  Chandravatiben Dhansukhlal Pachchigar College Of Homoeopathic Medicine And Hospital Post Graduation Devision Department of Homoeopathic Pharmacy 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India 395001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jahanvi Desai  C D Pachchigar College Of Homoeopathic Medicine And Hospital Surat Gujarat India 395001  Chandravatiben Dhansukhlal Pachchigar College Of Homoeopathic Medicine And Hospital Post Graduation Devision Department of Homoeopathic Pharmacy 2nd Floor Near Navjivan Circle Udhna Magdalla Road Surat Gujarat India 395001
Surat
GUJARAT 
9099925084

jahanvidesai5200@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of C D Pachchigar College of Homoeopathic Medicine And Hopsital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized Homoeopathic Medicine  Individualized Homoeopathic medicine will be prescribed on the basis of totality of symptoms And Individualized Susceptibility The Medicine Will Be Administered Through Olfectory Route As 4 to 5 Medicated Globules Will be Given in Half Dram Vial To Inhale To The Patient And This Type Of Intervention Will Be Accounted Hours To Days According To The Severity Of Symptoms Of The Case 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of both sexes
Age group 12 to 60 years
Acute exacerbation of asthma
 
 
ExclusionCriteria 
Details  Patients with irregular follow ups and not taking medicine regularly
Patients with malignant disease
Status asthmaticus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of olfactory route in management of acute exacerbation of asthma   9 months 
 
Secondary Outcome  
Outcome  TimePoints 
to reduce the frequency of recurrency  9 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/08/2025 
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="0"
Months="9"
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  

6.

BRIEF RESUME OF INTENDED WORK

6.1

 

NEED FOR THE STUDY

 

Homoeopathy is a scientific holistic system of medicine. As homoeopathy bears a specialty and originality in the field of medicine, its mode of administration of medicines also bears a specialty. Homoeopathic medicines can be administered through various routes to bring a curative effect, such as oral route, olfaction inhalation through nose or mouth, application to the skin, application of medicine through milk of mother or wet nurse, etc. Among these, the oral route is the commonest route for administration of medicines.

 

The subject dealing with the route of administration of drugs and medicines is termed “pharmaconomy”. 

 

In accordance with various data available, the ingestion takes about 30-90 minutes to cause The action, whereas inhalation acts in 2-3 minutes. Hence, as per this data, administration of The remedy through inhalation is more in action compared to ingestion of the same remedy.

 

Olfactory route of administration has been used hardly in practice and very less experiments are there. So, I wish to explore olfactory route.

 

ASTHMA is disease characterized by an episodic airway’s obstruction and airway hyperresponsiveness usually accompanied by airway inflammation. Which leads to breathlessness, chest tightness, coughing and wheezing.

 

Asthma is the most common chronic disease associated with significant morbidity and mortality. Asthma is more prevalent among children 8.4 percent than adults 7.7 percent. In children, the prevalence is greatest among boys 2:1 male-to-female ratio, with a trend toward greater prevalence in women in adulthood. In some patients, asthma resolves as they enter adulthood only to “recur” later in life.

 

Asthma affected an estimated 280 million people in 2022 and caused half a million deaths globally. India contributes to 12.9 percent of Global Asthma cases and 42.4 percent of global Asthma Deaths.

6.2

REVIEW OF LITERATURE:

INTRODUCTION

Asthma is a syndrome of variable airflow obstruction. It is characterized pathologically by bronchial inflammation with prominent eosinophil infiltration, physiologically by bronchial hyper-reactivity, and clinically by variable cough, chest tightness and wheeze.

 

Asthma exacerbations are progressive increases in asthma symptoms.

 

The symptoms of asthma exacerbations include coughing, wheezing, chest tightness, and shortness of breath. Some people may also experience rapid breathing or gasping for air during sleep. 

 

Asthma exacerbations frequently affect people who have severe asthma, and they usually have a trigger. Viral respiratory infections, such as the human rhinovirus subtypes A and C, are the most common cause of exacerbation of asthma.

 

Other possible triggers of asthma exacerbations include: 

       Bacterial infections 

       Allergies 

       Defective antiviral immunity 

       Allergen exposure 

       Pollutants, such as tobacco smoke and particulate matter 

       Occupational exposures

 

The signs and symptoms of asthma exacerbations include 

        Breathlessness  

        Coughing  

        Wheezing  

        Chest tightness  

        Agitation  

        Increased respiratory rate  

        Increased pulse rate  

        Decreased lung function

 

Asthmatic attack

Premonitory symptoms “asthmatic aura” – sometimes sneezing, flatulence and drowsiness, or restlessness and irritability. Dry irritant cough may precede or accompany attacks of wheezy breathlessness.

 

Paroxysm – usually sudden in middle of night. Sense of oppression in chest going into respiratory distress. Patient sits up and leans forward fighting for breath, or runs to window to relieve sense of suffocation. Anxiety, cyanosis, perspiration and cold extremities. Wheezing may be heard at a distance. on auscultation – inspiration short and high pitched, expiration prolonged, plenty of wheeze. Crackles may be heard at the bases towards the end of an attack. However, in very severe airways obstruction airflow may be so reduced that the chest is almost silent. Tachycardia especially in children.

  

Termination – spontaneously or as a result of therapy. As bronchial spasm gets less, patient is able to cough a little and may bring out viscid muco-fibrin.

 

Duration of attack – Varies from few minutes to several Hours. Sometimes paroxysms are continuous – “Status Asthmaticus”.

  

EXPOSURES AND RISK FACTORS OF ASTHMA 

1.    Allergen exposure in those with a predisposition to atopy  

2.    Occupational exposure  

3.    Air pollution

4.    Infections - Viral and Mycoplasma

5.    Tobacco  

6.    Obesity  

7.    Diet  

8.    Fungi in allergic airway mycosis  

9.    Acute irritants and reactive airway dysfunction syndrome (RADS)  

10. High-intensity exercise in elite athletes  

 

TRIGGERS OF AIRWAY NARROWING

        Allergens  

        Irritants  

        Viral infections  

        Exercise and cold, dry air  

        Air pollution  

        Drugs  

        Occupational exposures  

        Hormonal changes  

 

TYPES OF ASTHMA 

1.      Extrinsic asthma     

2.      Intrinsic asthma 

  Diagnosis: based on

1.      History   

2.      Physical examination  

3.      Full blood count   

4.      Sputum culture   

5.      IgE and IgE specific test  

6.      Lung function test  

7.      Chest radiograph

HOMOEOPATHIC APPROACH:  

Dr. Hahnemann explained route of administration in sec. 284- 285 Organon of medicine.

 

A more complete explanation of administering olfaction can be found in the footnote to aphorism 288 of 5 th edition of Organon of Medicine.

 

Hahnemann talks about the method of olfaction in footnote to aphorism 285 of 5 th Edition of Organon of Medicine.

 

It is especially in the form of vapor, by olfaction and inhalation of the medicinal aura that is always emanating from a globule impregnated with a medicinal fluid in a high development of power, and placed, dry, in a small phial, that the homoeopathic remedies act most surely and most powerfully. The homoeopathic physician allows the patient to hold the open mouth of the phial first in one nostril, and in the act of inspiration draw the air out of it into himself and then if he wished to give a stronger dose, smell in the same manner with the other nostril, more or less strongly.

 

v  Some common medicines used in a case of asthma. Which are as follows

 

BLATTA ORIENTALIS: Used as an expectorant and supportive remedy during acute attack of asthma, status asthmaticus or bronchitis to relieve bronchospasm and expectorant. Suited to subjects with stout and corpulent constitution< during rainy season, on lying down.

 

ARSENIC ALBUM: Breathing: asthmatic; must sit or bend forward; springs out of bed at night, especially after twelve o’clock; unable to lie down for fear of suffocation; attacks like croup instead of the usual urticaria.

 

IPECAC: Cough dry spasmodic, constricted, asthmatic. Difficult breathing from least exercise; violent dyspnea, with wheezing and anxiety about the stomach. Cough, with rattling of mucus in bronchi when inspiring. Threatened suffocation from mucus.

 

SPONGIA TOSTA: Great dryness of mucous membranes of air passages. Cough: dry, sibilant, like a saw driven through a pine board; agg sweets, cold drinks, smoking, lying with head low, dry cold winds; agg reading, singing, talking, swallowing; amel eating or drinking warm things. Croup: anxious, wheezing, agg before midnight. Palpitation: violent with pain and gasping respiration; awakened suddenly after midnight with suffocation and great anxiety.

 

NATRUM SULPH: Dyspnea; desire to take a deep breath during damp, cloudy weather. Humid asthma in children; with every change to wet weather; with every fresh cold; always worse in damp, rainy weather; sputa green, greenish, copious.

 

LOBELIA INFLATA: Dyspnea from constriction of chest; worse, any exertion. Sensation of pressure or weight in chest; better by rapid walking. Asthma; attacks, with weakness, felt in pit of stomach and preceded by prickling all over.


6.3

OBJECTIVE OF STUDY:

OBJECTIVE:

·       To assess the effectiveness of olfactory route in management of acute exacerbation of asthma

 
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