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CTRI Number  CTRI/2024/06/069367 [Registered on: 21/06/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   The role of anti - miasmatic homoeopathic medicines in the treatment of breathing difficulty 
Scientific Title of Study   The Effectiveness of Anti-miasmatic Management of Bronchial Asthma using Asthma Control Test Assessment criteria – A Prospective Study 
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 Tejas Vikas G G 
Designation  Postgraduate Student 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  3rd Floor College Building, Department of Organon of Medicine and Homoeopathic Philosophy, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari Dist., Tamil Nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  8870917529  
Fax    
Email  tejasvikassboan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M Murugan 
Designation  Professor and Head 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  3rd Floor College Building, Department of Organon of Medicine and Homoeopathic Philosophy, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari Dist., Tamil Nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443343707  
Fax    
Email  drmmuruganhomoeo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Murugan 
Designation  Professor and Head 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  3rd Floor College Building, Department of Organon of Medicine and Homoeopathic Philosophy, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari Dist., Tamil Nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443343707  
Fax    
Email  drmmuruganhomoeo@gmail.com  
 
Source of Monetary or Material Support  
Institution-Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari Dist., Tamil Nadu-629161, India. 
 
Primary Sponsor  
Name  Sarada Krishna Homoeopathic Medical College 
Address  Kulasekharam, Kanyakumari Dist., Tamil Nadu-629161, India. 
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 Tejas Vikas G G  Sarada Krishna Homoeopathic Medical College Hospital  Room No. 102, IA Unit-Medicine Outpatient Department, Inpatient Department of Organon of Medicine, Kulasekharam, Kanniyakumari, Tamil Nadu.
Kanniyakumari
TAMIL NADU 
8870917529

tejasvikassboan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sarada Krishna Homoeopathic Medical College  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  Anti - Miasmatic Homoeopathic Medicine  Case Taking will be done and the most suitable anti - miasmatic homoeopathic medicine selected based on totality of symptoms will be prescribed. One dose of the selected medicine will be given once in a week depending upon the improvement in the symptoms of the patient. The patient will be asked to take the medicine orally. Patient will be asked to come for regular follows up once in 2 weeks. The study will be conducted for 9 months.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient having symptoms of Bronchial Asthma such as dyspnea, expiratory wheeze, cough and tightness of chest. 
 
ExclusionCriteria 
Details  Pregnant and Lactating women.
Patients with other co-morbidities such as hypertension, diabetes mellitus, dyslipidemia, hyperthyroidism, hypothyroidism, etc.
Patients with complications of Bronchial Asthma such as Frequent respiratory infections, Pulmonary collapse, Respiratory failure, Pneumothorax, Cor pulmonale and Allergic bronchopulmonary aspergillosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Analyzing the severity of symptoms in cases diagnosed with Bronchial asthma before medication.  9 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Symptomatic and general improvement in the condition of patients through evaluation using assessment tool.  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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Various research studies have been conducted previously to evaluate the effectiveness of homoeopathic medicines in the treatment of Bronchial asthma. These studies focused either on witnessing the effectiveness of specific homoeopathic medicines or constitutional medicines in the management of Bronchial asthma. Most of the studies were conducted in the pediatric age group and thus the inclusion of other age groups, in studies related to Bronchial asthma were very less. Results of the previous studies were insignificant as the improvement in the general characteristics of the patient was not assessed. Studies done previously did not address the commonest age group affected and the most common exacerbating factor in cases of Bronchial asthma. In addition to this, the efforts to consider anti–miasmatic medicines in the treatment of Bronchial asthma were not taken. Thus, a prospective study to witness the effectiveness of anti–miasmatic medicines in the treatment of Bronchial asthma using Asthma Control Test (ACT) Assessment Criteria and to identify the commonest age group affected and the triggering factors in cases of Bronchial asthma is planned to fill the existing methodological gap. Thirty cases of Bronchial Asthma fulfilling the inclusion criteria will be purposively selected from the OPD, IPD, Rural Health Centers of Sarada Krishna Homoeopathic Medical College and Hospital. The cases will be subjected to data processing involving miasmatic analysis of symptoms to identify the miasm. A totality will be erected involving the miasm.  A suitable homoeopathic anti – miasmatic similimum will be selected accordingly. Selection of potency will be based on the susceptibility of the patients. One dose of the medicine selected will be repeated once in a week based on the improvement of the symptoms. The patient will be asked to administer the medicine orally. The patient will be asked to come for regular follows up one in 2 weeks. Changes observed in the patient will be recorded on subsequent follows-up. Pre and post assessment will be done using the Asthma Control Test (ACT) Assessment Criteria to evaluate the improvement of the patient. The assessment will be done in every follow up using assessment tool. 

 
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