| CTRI Number |
CTRI/2024/10/075691 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Accessing the utility of Boger Boenninghausens Characteristics Repertory in the management Bronchial Asthma. |
|
Scientific Title of Study
|
To explore the applicability of Boger Boenninghausens Characteristics Repertory in management 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 |
Dr Priyanka Borse |
| Designation |
PG Scholer |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
OPD 110, Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Post Limda, Taluka Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9377787774 |
| Fax |
|
| Email |
priyankaborse22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhavi Chaudhari |
| Designation |
Assistant Professor, Repertory |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Jawaharlal Nehru Homoeopathic Medical College, Department of Repertory, Post Graduation Division, Parul University, Post Limda, Taluka Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8511334512 |
| Fax |
|
| Email |
vaibhavi.chaudhari26118@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Borse |
| Designation |
PG Scholer |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
OPD 110, Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Post Limda, Taluka Waghodia, Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9377787774 |
| Fax |
|
| Email |
priyankaborse22@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD 110, Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Post Limda, Taluka Waghodia, Dist. Vadodara, Gujarat, India - 391760 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital at Post Limda, Taluka Waghodia, Dist. Vadodara, Gujarat, India 391760 |
| 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 Priyanka Borse |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
Jawaharlal Nehru Homoeopathic Medical College, Department of Repertory, Post Graduation Division, Parul University, P.O. Limda, Ta. Wadhodia, 391760
Vadodara
GUJARAT |
9377787774
priyankaborse22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homoeopathic Medical College and Hospital, Institutional Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine: Arsenic Album, Ammonium Carbonicum, Antimonium Tartaricum, Argentum Nitricum, Drosera Rotundifolia, Kali Carbonicum, Ipecacuanha |
Potency: Individualized Homoeopathic medicine will be prescribed 30, 200 and 1 M Potencies and Repetition will be done according to the susceptibility of patient and principles of Organon of Medicine. Frequency of Dosage: 15 days or as per requirement of Case. Route of administration: Oral (sublingual). Duration: 3 months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnosed Bronchial Asthma cases.
Patients of various occupations and different socio-economic status will be included. |
|
| ExclusionCriteria |
| Details |
Patients who need intensive care and management.
Patients with irreversible pathalogical changes like emphysema.
Patients who have systemic pathalogical changes along with Bronchial Asthma.
Patients with status asthmaticus.
Pregnancy and lactating mothers.
Patients with irregular follow up.
Patients who need hospitalisation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected from the study that it will increase the scope of BBCR in selecting individualized Homoeopathic medicine in the treatment of Bronchial Asthma and will provide good alternatives to conventional mode of treatment with no side effects. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity & outcome of Bronchial Asthma symptoms before and after treatment. |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/11/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
This study is Prospective interventional non-randomized study. By using BBCR individualized Homoeopathic medicine will be selected for the Bronchial Asthma Patients. The primary outcome is to know the effectiveness of BBCR in cases of Bronchial Asthma Patients and also assessing the before and after treatment outcome by self made questionnaire. |