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CTRI Number  CTRI/2024/12/078095 [Registered on: 13/12/2024] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Diagnostic
Preventive
Screening 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Chronic bronchitis, an inflammation of bronchial lining, characterized by persistent productive cough, dyspnoea and chest tightness. This study aims to provide new insights and treatment option with homoeopathic medicine as mucolytic and become beneficial in reducing symptoms. 
Scientific Title of Study   Evaluation the comparative efficacy of homoeopathic mucolytic in chronic bronchitis: a randomized trial of senega officinalis, silphium, ammoniacum gummi and balsamum peruvianum using cat criteria  
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 Dhara Patel 
Designation  BHMS, PG Scholar 
Affiliation  Parul institute of homoeopathy and research, Parul University, Post Limda, Waghodia, Vadodara  
Address  101-C medicine opd , Parul institute of homoeopathy and research, Parul University, Post Limda, Waghodia, Vadodara, gujarat, india

Vadodara
GUJARAT
391760
India 
Phone  7359356337  
Fax    
Email  dp2304401@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dipika Sindha 
Designation  Associate professor , department of materia medica, PIHR  
Affiliation  Parul institute of homoeopathy and research, Parul University, Post Limda, Waghodia, Vadodara  
Address  101 c medicine opd, Parul institute of homoeopathy and research, Parul University, Post Limda, Waghodia, Vadodara, gujarat, india

Vadodara
GUJARAT
391760
India 
Phone  9978919488  
Fax    
Email  dipika.sindha87141@paruluniversity.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dhara Patel 
Designation  BHMS, PG Scholar 
Affiliation  Parul institute of homoeopathy and research, Parul University, Post Limda, Waghodia, Vadodara  
Address  101-c medicine opd, Parul institute of homoeopathy and research, Parul University, Post Limda, Waghodia, Vadodara, gujarat, india

Vadodara
GUJARAT
391760
India 
Phone  7359356337  
Fax    
Email  dp2304401@gmail.com  
 
Source of Monetary or Material Support  
Parul institute of homoeopathy and research hospital, Parul University, Post Limda, Waghodia, Vadodara, 381760, Gujarat, India  
 
Primary Sponsor  
Name  Dr Dhara Patel 
Address  Parul institute of homoeopathy and research, Parul University, Post Limda, Waghodia, Vadodara,391760, Gujarat, India  
Type of Sponsor  Research institution and hospital 
 
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 Dhara Patel  Parul institute of homoeopathy and research hospital, parul universiry, vadodara, gujarat  101 c medicine opd, Parul institute of homoeopathy and research hospital, parul universiry, vadodara, 391760, Gujarat, India
Vadodara
GUJARAT 
7359356337

dp2304401@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, PIHR IECHR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J418||Mixed simple and mucopurulent chronic bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AMMONIACUM GUMMI   according to randomized process, i will give the any one medicine from taken 4 medicine. potency and repetition will be decide according to hahnemmans guideline given in organon of medicine 6th edition  
Comparator Agent  BALSAMUM PERUVIANUM   according to randomized process, i will give the any one medicine from taken 4 medicine. potency and repetition will be decide according to hahnemmans guideline given in organon of medicine 6th edition 
Intervention  SENEGA OFFICINALIS   according to randomized process, i will give the any one medicine from taken 4 medicine. potency and repetition will be decide according to hahnemmans guideline given in organon of medicine 6th edition  
Comparator Agent  SILPHIUM   according to randomized process, i will give the any one medicine from taken 4 medicine. potency and repetition will be decide according to hahnemmans guideline given in organon of medicine 6th edition  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  • Individual with diagnostic symptoms of chronic bronchitis
• Age group between 40-70 years
• Patient of both sexes
• Patient from all socio economical status
• Patient who are willing for chest x ray investigation (before-after treatment)
 
 
ExclusionCriteria 
Details  • Patient with severe respiratory function impairment
• Patient with any malignant disease
• Patient with severe comorbidities
• Patient with autoimmune disorders
• Patient present with most similimum medicine indication other then taken medicine for this synopsis
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the highest mucolytic effect of any one medicine from all of four medicine taken in study - Senega Officinalis, Silphium, Ammoniacum Gummi and Balsam Peruvianum in cases of chronic bronchitis along with their comparative analysis.   12 months , per patient 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the impact of these remedies on patients quality of life and respiratory function.  12 months per patient 2 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   25/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

Chronic bronchitis one of the disorders under chronic obstructive pulmonary disease (COPD), which is frequently linked to prolonged exposure to irritants like cigarette smoke, air pollution, or work-related dangers. Chronic bronchitis, an inflammation of the airways, characterized by a persistent productive cough and expectoration that lasts for two consecutive years and at least three months out of the year, is a common respiratory condition affecting individuals in their middle to later years. Mucus-secreting glands and goblet cells hyper-proliferate as a result of this inflammation, which results in increased mucus production and impeded mucociliary clearance. Sputum production, breathing difficulties, and a persistent productive cough are the outcome, and they get worse with time. It is traditionally managed with conventional therapies such as bronchodilators, mucolytics and corticosteroids. With medicinal management it is necessary to stop smoking and avoid irritants. Along with these oxygen therapy, vaccination, pulmonary rehabilitation and antibiotics are also required occasionally. 

Despite the availability of various treatments, many remain dissatisfied with conventional therapies, and there is a growing interest in exploring alternative options. Homoeopathic remedies such as Senega Officinalis, Silphium, Ammoniacum Gummi, and Balsam Peruvianum offer alternative approaches to managing chronic bronchitis as mucolytics. By evaluating their mucolytic efficacy, this research aims to provide new insights and treatment options for chronic bronchitis, potentially influencing clinical practice and expanding the understanding of these less-utilized remedies.

 
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