| CTRI Number |
CTRI/2024/03/063943 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effectiveness of the homoeopathic remedy in improving the quality of life in patients suffering from chronic cough selected using S.R. Phataks A Concise Repertory of homoeopathic medicines. |
|
Scientific Title of Study
|
Effectiveness of the homoeopathic remedy in improving the quality of life in patients suffering from chronic cough selected using S.R. Phataks A Concise Repertory of homoeopathic medicines |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jain Rekhit Rakesh |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy, Kolkata |
| Address |
Department of Case Taking and Repertory OPD no. 10, National Institute of Homoeopathy Block GE, Sector III, Salt Lake, Kolkata -700106, West Bengal, India
A 501, Eisha Pearl, S no. 44 Market yard annexe, Kondhwa Khurd, Pune, Maharashtra, 411048
Kolkata
WEST BENGAL
700106
India |
| Phone |
9607052941 |
| Fax |
|
| Email |
rekhit.jain72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binod Kumar Bhagat |
| Designation |
Professor, Case taking and Repertory |
| Affiliation |
National Institute of Homoeopathy, Kolkata |
| Address |
Department of Case Taking and Repertory OPD no. 10 National Institute of Homoeopathy Block GE, Sector III, Salt Lake, Kolkata -700106, West Bengal, India
Kolkata
WEST BENGAL
700106
India |
| Phone |
8210003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binod Kumar Bhagat |
| Designation |
Professor, Case taking and Repertory |
| Affiliation |
National Institute of Homoeopathy, Kolkata |
| Address |
Department of Case Taking and Repertory OPD no. 10 National Institute of Homoeopathy Block GE, Sector III, Salt Lake, Kolkata -700106, West Bengal, India
Kolkata
WEST BENGAL
700106
India |
| Phone |
8210003741 |
| Fax |
|
| Email |
dr.binodkbhagat@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy Block GE, Sector III, Salt Lake, Kolkata -700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy Block GE, Sector III, Salt Lake, Kolkata -700106, West Bengal, India |
| 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 Binod Kumar Bhagat |
National Institute of Homoeopathy |
OPD no. 10, Department of Case taking and Repertory, Block GE, Sector III, Salt Lake, Kolkata -700106, West Bengal, India
Kolkata
WEST BENGAL |
8210003741
dr.binodkbhagat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of the National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicine |
Individualised Homoeopathic medicine will be selected using S R Phataks " A Concise Repertory of Homoeopathic Medicines". Dosage,frequency and repetition of the medicine will be done as per the susceptibility of the patient and according to Homoeopathy principles.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient belonging to 18-60 years of age group, male or female, of all religion, caste and socio-economic status.
2) Patient willing to take part in study and ready to give consent for the same.
3) Patient who are able to read, write or understand Hindi or English Or Bengali.
4) Patient suffering from cough more than 8 weeks
5) Patient with known but controlled systemic diseases.
6) Patient willing to fill the LCQ questionnaire
|
|
| ExclusionCriteria |
| Details |
1) Patient who is diagnosed or is under treatment for Active Pulmonary Tuberculosis.
2) Patient who is taking Angiotensin Converting Enzyme Inhibitors or Beta blockers or Non Steroidal Anti Inflammatory Drugs.
3) Patient who are having malignant diseases/ life threatening disease/ psychiatric illness or immune compromised state or any other disease who needs surgical intervention.
4) Patient in severe respiratory distress, having SpO2 less than 95% or episodes of Hemoptysis.
5) Patients with uncontrolled systemic illness or any organ failure.
6) Pregnant and lactating woman.
7) Current smokers or substance abuse dependence.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of increase or decrease in Leicester cough questionnaire total score in patient suffering from chronic cough |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="6"
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
|
Chronic cough is when a cough persists for more than 8 weeks. Chronic cough is a common and distressing condition, that significantly impacts the quality of life. This impact on quality of life will be calculated using the Leicester cough questionnaire, and a baseline total score will be calculated. Patients will be given individualized Homoeopathic medicine based on the symptoms and by repertorisation using S.R. Phatak’s "A Concise Repertory of Homoeopathic Medicine". After 6 months total score in the Leicester Cough questionnaire will be calculated, and assessed after 6 months of medical intervention. |