FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091494 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   How Homoeopathic Medicine Improves Sign And Symptoms Of Asthma And Can Help Reduce Inhaler Usage And Dependency 
Scientific Title of Study   Utility Of Homoeopathy In Reducing Bronchodilators Dependency In Cases Of Bronchial 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  Vaishali Shashikant Pathak 
Designation  PG Scholar 
Affiliation  C D Pachchigar College of Homoeoapthic Medicine and Hospital Surat Gujarat India 
Address  Department Of Practice Of Medicine Division Of Post Graduation 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhna Magdalla Road Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9409230443  
Fax    
Email  vaishalip3232@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer Upadhyay 
Designation  Head Of Department Of Practice Of Medicine 
Affiliation  C D Pachchigar College of Homoeoapthic Medicine and Hospital Surat Gujarat India 
Address  Department Of Practice Of Medicine Division Of Post Graduation 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhna Magdalla Road Surat Gujarat

Surat
GUJARAT
395001
India 
Phone  9426836991  
Fax    
Email  drsameerupadhyay@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sameer Upadhyay 
Designation  Head Of Department Of Practice Of Medicine 
Affiliation  C D Pachchigar College of Homoeoapthic Medicine and Hospital Surat Gujarat India 
Address  Department Of Practice Of Medicine Division Of Post Graduation 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhna Magdalla Road Surat Gujarat


GUJARAT
395001
India 
Phone  9426836991  
Fax    
Email  drsameerupadhyay@rediffmail.com  
 
Source of Monetary or Material Support  
C D Pachchigar College of Homoeoapthic Medicine and Hospital Surat Gujarat India 395001 
 
Primary Sponsor  
Name  C D Pachchigar College of Homoeoapthic Medicine and Hospital Surat Gujarat India  
Address  Department Of Practice Of Medicine Division Of Post Graduation 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital 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 Sameer J Upadhyay  C D Pachchigar College of Homoeoapthic Medicine and Hospital Surat Gujarat India  Department Of Practice Of Medicine Division Of Post Graduation 2nd floor C D Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhna Magdalla Road Surat Gujarat
Surat
GUJARAT 
9426836991

drsameerupadhyay@rediffmail.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 Hospital  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  ndividualized Homoeopathic medicine Will Be Prescribed On The Basis Of Totality Of Symptoms And Individual Susceptibility The Medicine Will Be Administered Orally In The Form Of Medicated Globules 4 to 6 Globules Per Dose The Intervention Will Be 15 to 30 Days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient of all age and both sexes
Irrespective of socioeconomic condition and religion are included
Cases with functional changes and no structural changes
Cases which are diagnosed clinically according to history and sign and symptoms Investigations and Spirometr
 
 
ExclusionCriteria 
Details  Patients with irregular follow-ups and not taking medicine regularly
Cases having irreversible pathologies
Cases having chronic illness which may causing acute exacerbation and may need lifesaving support
Medico legal cases
Cases with coexisting severe systemic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To reduce the requirement of bronchodilators dependency in cases of asthma with the help of individualized homoeopathic medicine  9 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study Etiology clinical presentation pathophysiology and management medicinal and lifestyle management of bronchial asthma  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)   06/08/2025 
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 STUDY
Asthma is a widely prevalent clinical condition, particularly common among children, and is considered the most frequent chronic illness in this age group. It affects approximately 235 million individuals globally, with around 25 million in the United States alone. Asthma contributes to more than 10 million medical consultations each year in the United States. The International Study of Asthma and Allergies in Children conducted a comprehensive global survey which revealed significant variations in the prevalence and severity of asthma across different countries. Currently, about 300 million people suffer from asthma worldwide, and its prevalence increases by nearly fifty percent each decade. In India, the estimated prevalence is approximately 2468 cases per one lakh individuals, according to the National Family Health Survey-2.

The rise in hospital admissions, especially among young children, highlights issues such as worsening asthma severity, inadequate disease management, and the impact of poverty. Asthma is fundamentally an inflammatory and obstructive condition of the airways, which may result from allergens, stress, suppression, occupational factors, or seasonal changes. Research indicates a steady increase in the occurrence of asthma. Homeopathic constitutional remedies have shown potential to provide effective and lasting relief in various types of asthma. Conventional treatments such as corticosteroid inhalers have limitations including user errors, dependency, side effects, and high costs. In contrast, homeopathy offers a holistic approach that considers the physical, mental, and emotional aspects of each individual. The aim of homeopathic medicine is not only to treat bronchial asthma but also to address its root causes and the overall health of the individual.

6.2 REVIEW OF LITERATURE

Bronchial Asthma
Asthma is recognized as a chronic inflammatory condition of the airways involving various immune and structural cells. It is marked by recurring symptoms such as wheezing, shortness of breath, chest tightness, and coughing, which can vary in frequency and intensity.

Pathogenesis
Airway hyperresponsiveness is a defining feature of asthma, wherein the airways react excessively to stimuli that normally would not cause such reactions. Inflammation in asthma is typically chronic and most often eosinophilic in nature, although in severe cases, neutrophilic inflammation may dominate. Mast cells are also frequently involved. Airway smooth muscle contributes to asthma through hyperresponsiveness, structural changes like hypertrophy, and the production of inflammatory mediators. Inflammatory pathways in asthma can be broadly classified into Type 2 and non-Type 2 inflammation, with Type 2 involving interleukins produced by T-helper cells.

Miscellaneous Forms of Asthma
Asthma can present in various forms such as occupational asthma, which is induced by specific workplace exposures, aspirin-induced asthma, which follows a characteristic sequence of symptoms including rhinitis and nasal polyps, and exercise-induced asthma, where symptoms are triggered by physical activity due to airway drying and resultant bronchospasm.

Clinical Features
Symptoms typically include episodic wheezing, cough, breathlessness, and chest tightness. The cough may produce sputum and can be the sole presenting symptom. Breathlessness results from dynamic lung hyperinflation during acute attacks. Although wheezing is a common symptom, no single feature is definitive for asthma. In young patients, chest tightness is often a helpful indicator.

Diagnosis
Diagnostic measures include complete blood count, eosinophil count, serum IgE levels, pulmonary function tests, peak flow measurements, and chest X-rays.

Differential Diagnosis
Conditions to consider include chronic obstructive pulmonary disease, foreign body aspiration, bronchiectasis, Churg Strauss syndrome, interstitial lung disease, heart failure, allergic bronchopulmonary aspergillosis, and gastroesophageal reflux disease.

Risk Factors
Contributing factors include indoor and outdoor allergens, smoking, deficiencies in vitamin D, use of acetaminophen or aspirin, obesity, atopic tendencies, parasitic infections, and environmental pollutants.

Treatment
Treatment during acute asthma attacks includes removing the triggering agent, administering steroids, and using long-acting or short-acting bronchodilators as appropriate based on the patient’s age. Chronic management focuses on addressing the underlying inflammation and removing avoidable causes like allergens and smoking. Supplementation of vitamins such as B12 and D3 may help in specific cases. Long-term monitoring through spirometry is recommended if symptoms persist despite standard treatment.

Diet and Regimen
Patients are advised to avoid fermented foods, cold foods and drinks, foods with preservatives or artificial colors, and processed items. A healthy diet consisting of fresh fruits, vegetables, whole grains, and foods rich in vitamins D and B12 is recommended. Lean meats, poultry, fish, eggs, and nuts are also beneficial.

Homoeopathic Approach
Modern lifestyle changes have contributed to an increase in psychosomatic cases of asthma. Hahnemann’s aphorisms emphasize the impact of chronic miasms, emotional suppression, and hereditary tendencies in the development of asthma. According to aphorism seventy seven, some conditions mimic chronic diseases but are actually due to emotional or environmental suppression. Aphorisms two hundred ten to two hundred thirty link emotional disturbances with physical symptoms. Aphorism thirty eight explains how the suppression of skin diseases may lead to lung conditions. Homeopathic treatment addresses the entire individual, aiming to remove the root cause and hereditary tendencies through dynamic medicines prescribed on the basis of individual symptom totality.

Commonly used homeopathic remedies include:

Arsenicum album for anxiety-induced breathlessness and symptoms worsening after midnight
Natrium sulphuricum for humid asthma aggravated by damp weather
Antimonium tartaricum for asthmatic patients with mucus rattling and little expectoration
Spongia tosta for dry, barking coughs and labored breathing
Blatta orientalis for bronchitis-associated asthma, especially in stout individuals
Ictodes foetida for dust-induced asthma with bloating and respiratory difficulty
Pulsatilla nigricans for asthma linked to hormonal and emotional disturbances
Ipecacuanha for spasmodic coughs with nausea and vomiting
Lobelia inflata for psychogenic asthma with gastric symptoms
Sambucus nigra for infantile asthma with nighttime attacks

Other remedies include grindelia robusta, sulphur, tuberculinum, justicia adhatoda, bromium, aspidosperma, and senega officinalis.

6.3 OBJECTIVE OF STUDY

The study aims to explore the etiology, clinical manifestations, pathophysiology, and both medicinal and lifestyle-based management of bronchial asthma. It seeks to observe the improvement in symptoms following homeopathic treatment and to evaluate how this influences the prognosis and control of the disease. A key objective is to determine whether individualized homeopathic remedies can reduce the frequency and dosage of bronchodilator use among asthma patients.

 
Close