| 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
|
|
|
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
|
|
|
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
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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. |