| 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
|
|
|
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
|
|
|
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. |