| CTRI Number |
CTRI/2024/07/069708 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Bronchial asthma with Homoeopathic medicine |
|
Scientific Title of Study
|
A clinical study on Bronchial Asthma and its individualistic Approach |
| 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 Sanam Doli |
| Designation |
P.G. Scholar Dept of Practice of Medicine |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital |
| Address |
Room no 03 PG Block Academic Building R.B.T.S. Govt. Homoeopathic Medical College and Hospital
Muzaffarpur
BIHAR
842002
India |
| Phone |
07543038016 |
| Fax |
|
| Email |
sanamdoli786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanak Kumar |
| Designation |
Associate Professor |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital |
| Address |
Room no 03 PG Block Academic Building R.B.T.S. Govt. Homoeopathic Medical College and Hospital
Muzaffarpur
BIHAR
842002
India |
| Phone |
7903631714 |
| Fax |
|
| Email |
drkanak92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanak Kumar |
| Designation |
Associate Professor |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical College and Hospital |
| Address |
Room no 03 PG Block Academic Building R.B.T.S. Govt. Homoeopathic Medical College and Hospital
BIHAR
842002
India |
| Phone |
7903631714 |
| Fax |
|
| Email |
drkanak92@gmail.com |
|
|
Source of Monetary or Material Support
|
| RBTS Govt Homoeopathic Medical College and Hospital Ramadayalu Muzaffarpur Bihar India 842002 |
|
|
Primary Sponsor
|
| Name |
RBTS Govt Homoeopathic Medical College and Hospital |
| Address |
RBTS Govt Homoeopathic Medical College and Hospital Ramadayalu Muzaffarpur Bihar India 842002 |
| Type of Sponsor |
Government 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 Sanam Doli |
RBTS Govt Homoeopathic Medical College and Hospital |
OPD 1 OPD 4 OPD 5 OPD 6 IPD Hospital Block RBTS Govt Homoeopathic Medical College and Hospital
Muzaffarpur
BIHAR |
7543038016
sanamdoli786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of RBTS Govt Homoeopathic Medical College and Hospital |
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 |
| Comparator Agent |
Comparator Agent |
NIL |
| Intervention |
Individualized homoeopathic medicine |
Individualized homoeopathic medicine of 30C 200C 1M 10M potency to be given to the patient and follow to be done every 14 days for the period of total duration of one year |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study.
Patients having age group 40-60 years.
Case confirmed by the Ig-E level and PEFR.
Patients having history of smoking and allergies.
Female patients, who cook food on Anagithi. |
|
| ExclusionCriteria |
| Details |
Severe persistent cases of bronchial asthma according to GINA guidelines.
Patient having history of Tuberculosis, Chronic obstructive pulmonary diseases,
Emphysema, Infectious & complicated respiratory disorders.
Those patients who doesn’t give their consent to participate in the study.
Patients doesn’t have any systemic diseases, having no any malignant changes and life style
disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the changes in sign & symptoms.
To observe the changes in IgE level, PEFR(Peak expiratory flow rate) |
The outcome will be assessed within a duration of one year from the recruitment date |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To use the Statistical tools to assess the pre and post treatment effect.
• To analyse the lifestyle changes in the management of bronchial asthma.
• To analyse the environmental allergens of bronchial asthma.
• To analyse the socioeconomic status of the patients.
• To study the sociodemographic features with respect to bronchial asthma. |
1 year |
|
|
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 4 |
|
Date of First Enrollment (India)
|
09/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Asthma is a major noncommunicable disease (NCD), affecting both children and
adults, and is the most common chronic disease among children. Inflammation and
narrowing of the small airways in the lungs cause asthma symptoms, which can be any
combination of cough, wheeze, shortness of breath and chest tightness1
. After the
COVID19, the Case of asthma gradually increase due to which patients day today activity
will hamper and thus economy will be affected. Asthma affected an estimated 262 million
people in 2019 (1) and caused 455 000 deaths, it increases to 339 million people in
2023.Now a days about 1000people per day die from asthma. Inhaled medication can
control asthma symptoms and allow people with asthma to lead a normal, active life.
Avoiding asthma triggers can also help to reduce asthma symptoms. Most asthma-related
deaths occur in low- and lower middle-income countries, where under-diagnosis and under treatment is a challenge .WHO is committed to improving the diagnosis, treatment and
monitoring of asthma to reduce the global burden of NCDs and make progress towards
universal health coverage |