| CTRI Number |
CTRI/2025/02/080661 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Individualised Homoeopathic treatment of bronchial asthma in adults aged 18 to 60 years |
|
Scientific Title of Study
|
Role of
Invididualized Homoeopathic Medicine in Bronchial Asthma in cases of Young and
Middle Age Group Patients. |
| 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 Vikas Chaudhary |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College Lucknow |
| Address |
Department of Organon of Medicine
State National Homoeopathic Medical College, Viraj Khand 1 Gomti nagar Lucknow
Viraj Khand 1 Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
06392573971 |
| Fax |
|
| Email |
vik15aug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Sharma |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital Gomtinagar Lucknow |
| Address |
Department of Practice of Medicine
State National Homoeopathic Medical College and Hospital
Viraj Khand 1 Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8178562292 |
| Fax |
|
| Email |
drnutansharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Sharma |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital Gomtinagar Lucknow |
| Address |
Department of Practice of Medicine
State National Homoeopathic Medical College and Hospital
Viraj Khand 1 Gomtinagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8178562292 |
| Fax |
|
| Email |
drnutansharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic medical college and Hospital Viraj Khand Gomti Nagar Lucknow Uttar Pradesh India 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Vikas Chaudhary |
| Address |
Department of Organon of Medicine and Homoeopathic Philosophy
State National Homoeopathic Medical College and Hospital, Viraj Khand Gomti Nagar,Lucknow |
| Type of Sponsor |
Other [Self] |
|
|
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 Vikas Chaudhary |
State National Homoeopathic medical college Lucknow |
OPD -1
Department of Organon of Medicine
State National Homoeopathic Medical College and Hospital Viraj khand 1 Gomti nagar Lucknow
Lucknow
UTTAR PRADESH |
6392573971
vik15aug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee State National Homoeopathic medical college Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
Intervention is planned as administering individualized homoeopathic medicine to a group of 30 patients suffering from Bronchial Asthma after detailed case taking and repertorization.
Individualized homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient.
Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine(preserved in 90%v/v ethanol) to be taken orally on an empty stomach. Dosage and repetition will depend upon the individual requirement of the case. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) The sample includes patient of 18 to 60 years old age group of both sexes.
2) Patient fulfilling GINA(Global Initiative for Asthma) diagnostic criteria.
3) Informed and written consent |
|
| ExclusionCriteria |
| Details |
1) Patients below the age of 18 and over the age of 60.
2) Chronic systemic illness (e.g. Epilepsy, digestive, cardiovascular, renal and endocrine disorders.)
3) Use of medications for some other conditions or disease.
4) Patients with developed complications of asthma. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) it is expected that individualized homoeopathic Medicines selected will prove effective in the management of bronchial asthma.
2) The study will determine whether the quality of life of patients suffering From asthma can be improved by using individualized Homoeopathic medicine. |
4weeks, 24weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. If the results would be positive than a certain group of medicines can be Found out which would frequently prove useful in management of bronchial asthma
2.the study will go into public domain & will be beneficial for public. |
12weeks,24weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2025 |
| 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
|
The present study is going to assess the role of individualized homoeopathic medicine in improving the symptoms of bronchial asthma and improvement in their healthy lifestyle.. A detailed case taking will be done using a standard homoeopathic case taking proforma, and after the diagnosis has been made the patient will be asked to fill the Asthma Control Test form for evaluation of the degree of disease, and maintaining all the previous and subsequent scores. The individualized homoeopathic medicine will be selected on the basis of repertorial evaluation. The potency and dose will be selected according to the individual case and follow ups will be done in every 15 days. The Quality of life will also be assessed by the use of Modified Naranjo Algorithm.
|