| CTRI Number |
CTRI/2024/09/073325 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Managing chronic bronchitis using Homoeopathic medicines |
|
Scientific Title of Study
|
Management of chronic bronchitis by identifying similimum using repertory of the Homoeopathic Materia Medica by J.T.Kent |
| 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 Sushmitha R |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of Homoeopathic repertory and case taking
White memorial homoeo medical college and hospital Attoor Veeyanoor Kanyakumari district
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9444874772 |
| Fax |
|
| Email |
sushmithars95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhuvaneswari G |
| Designation |
Associate professor |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of Homoeopathic repertory and case taking
White memorial homoeo medical college and hospital Attoor Veeyanoor Kanyakumari district
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9444874772 |
| Fax |
|
| Email |
bhuvanabhms1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmitha R |
| Designation |
PG Scholar |
| Affiliation |
White memorial homoeo medical college and hospital |
| Address |
Department of Homoeopathic repertory and case taking
White memorial homoeo medical college and hospital Attoor Veeyanoor
White memorial homoeo medical college and hospital Attoor Veeyanoor Kanyakumari district
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9444874772 |
| Fax |
|
| Email |
sushmithars95@gmail.com |
|
|
Source of Monetary or Material Support
|
| White memorial homoeo medical college and hospital Attoor Veeyanoor Kanyakumari district Tamil Nadu India 629177 |
|
|
Primary Sponsor
|
| Name |
White memorial homoeo medical college and hospital |
| Address |
White memorial homoeo medical college and hospital Attoor Veeyanoor kanyakumari district Tamilnadu 629177 |
| 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 Sushmitha R |
White memorial homoeo medical college hospital |
Department of Homoeopathic repertory and case taking Opd Ipd and peripheral centers
White memorial homoeo medical college and hospital veeyanoor attoor 629177
Kanniyakumari
TAMIL NADU |
9444874772
sushmithars95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic similimum |
In globules tds once in 15 days through oral route potency selected based on susceptibility of the patient |
| Comparator Agent |
nil |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from chronic bronchitis on the basis of clinical history and findings
Subjects of both sexes
Age group from 35-65 years |
|
| ExclusionCriteria |
| Details |
Patients suffering from other severe systemic diseases autoimmune diseases
Below the age of 35 years and above the age of 65 years
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| X ray reports taken before and after treatment |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment using copd assessment test cat score |
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
|
N/A |
|
Date of First Enrollment (India)
|
05/09/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - all the data wil be provided through email sushmithars95@gmail.com
- For how long will this data be available start date provided 12-03-2027 and end date provided 12-03-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Management of chronic bronchitis by identifying similimum
using repertory of the Homoeopathic Materia medica by James Tyler Kent Chronic bronchitis is a chronic productive cough lasting more than three
months and occurring within a span of two years the prevalence of the
disease has a great impact on society and on health care systems around the
world the repertory of the Homoeopathic Materia medica by J T Kent which
is full of generals helps us to work out cases based on his principles and this
repertory is undoubtedly the most comprehensive and when a prescriber has
become thoroughly familiar with its terminology arrangement and use it will be
found to be the most practical the participants of both sexes aged 35 - 65
years who are visiting the outpatient department inpatient department and
peripheral centres of White memorial homoeopathic medical college and
hospital will be assessed using the COPD assessment test score a minimum
sample size of 30 participants will be chosen satisfying the inclusion and
exclusion criteria cases will be taken in detail and recorded in the structured
case sheet formulated for the study and the similimum will be identified
on the basis of repertorization using the repertory of the Homoeopathic Materia
medica by James Tyler Kent and the medicines are administered to the patients
follow up will be done once in 15 days to 1 month for the report or as per
their case result will be assessed by x ray reports taken before and after
treatment
|