| CTRI Number |
CTRI/2025/02/080566 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Individualized Homoeopathy vs Standard care in management of Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathy vs Standard care in the Management of Chronic Obstructive Pulmonary Disease: A Multicentric Randomized Controlled Trial |
| 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 Bharti Wadhwa |
| Designation |
Research Officer (H)/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 417,Central Council for Research in Homoeopathy,D Block,Janakpuri Institutional Area,Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
09818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Research Officer (H)/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 417,Central Council for Research in Homoeopathy,D Block,Janakpuri Institutional Area,Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
09818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti Wadhwa |
| Designation |
Research Officer (H)/Scientist-3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room No. 417,Central Council for Research in Homoeopathy,D Block,Janakpuri Institutional Area,Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
09818262049 |
| Fax |
|
| Email |
bhartiwadhwa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, Janakpuri, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
D Block,Janakpuri Institutional Area,Janakpuri, New Delhi
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suraiya Praveen |
Dr. Anjali Chatterjee Regional Research Institute (H) Kolkata |
Room No. 4, Clinical Research department Dr. Anjali Chatterjee Regional Research Institute (H), 50 ,Rajendra Chatterjee Road, Kolkata 700035
Kolkata
WEST BENGAL |
9231758284
drsuraia@gmail.com |
| Dr Padmalaya Rath |
Dr. D.P. Rastogi Central Research Institute (H), Noida |
Room No. 103, Clinical Research department Dr. D.P. Rastogi Central Research Institute (H),A-1/1 Sector 24, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9811704560
drpadmalaya@gmail.com |
| Dr R Bhuvaneswari |
National Homoeopathy Research Institute in Mental Health |
Room No. 106,Clinical Research department, National Homoeopathy Research Institute in Mental Health Sachivothamapuram (PO)Kurichy Kottayam Kerala 686532
Kottayam
KERALA |
08281475541
drbhuvaneswarir@gmail.com |
| Dr AK Prusty |
Regional Research Institute (H), Puri |
Room No. 10, Clinical Research department Regional Research Institute (H), Gopal Ballav Road, Puri 752001 Odisha
Puri
ORISSA |
9778461673
prustyakshayakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe (Puri) |
Approved |
| Institutional Ethics Committee (Kolkata) |
Approved |
| Institutional Ethics Committee (Kottayam) |
Approved |
| Institutional Ethics Committee (Noida) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Allopathy |
Allopathic medicine will be prescribed by pulmonologist in allopathic group. Dose and Frequency of the medicine will be as per discretion of the pulmonologist based on improvement in the case. Route of administration will be oral. Total duration of intervention will be 01 year |
| Intervention |
Homoeopathy |
Individualized Homeopathic medicines will be given. The dose of the medicine will be in centesimal potency in the form of globules (4 globules/dose). Frequency of the medicine will be as per discretion of the prescribing investigator based on improvement in the case. Route of administration will be oral in the form of globules (4pills/dose). Total duration of intervention will be 01 year |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of COPD.
FEV1 FVC ratio less than 0.7.
FEV1 greater than 50%.
Patients presenting with chronic cough with excessive mucopurulent expectoration for at least 3 months in a year for more than two consecutive years.
Patients willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from other respiratory diseases like bronchial asthma, active pulmonary tuberculosis, broncho-pulmonary mycosis, cor-pulmonale, acute bronchitis, pulmonary thromboembolism, pulmonary hypertension, bronchiectasis, Sarcoidosis, congestive cardiac failure etc.
FEV1 less than 50%
Persons requiring hospitalization with other co-morbid conditions.
Persons requiring oxygen therapy and hospitalization.
Persons not willing to provide consent for the study.
History of recent steroid and antibiotics intake (within last 4 weeks).
Pregnant and Lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess effectiveness of homoeopathic medicines vs standard care in the management of COPD through COPD assessment test (CAT) score |
Primary Outcome will be evaluated every month for 1 year. Assesment will be done after completion of study at 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare changes in FEV1 FVC Ratio, FEV1 & FVC values in both the groups through spirometry.
2.To compare changes in the number of COPD exacerbations in both the groups (through measuring FDI of episodes each
month)
|
Secondary Outcome will be evaluated every month for 1 year. Assessment will be done after completion of study at 1 year |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
01/03/2025 |
| 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="2"
Months="6"
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
|
A Multicentric Randomized Controlled Trial will be conducted at 4 sites to compare the effectiveness of Individualized Homoeopathy vs Standard care in the Management of Chronic Obstructive Pulmonary Disease. Primary objective is to assess the effectiveness of individualized homoeopathic medicines vs standard care in management of COPD through COPD assessment test (CAT) score . Secondary objectives will be to compare changes in FEV1 FVC Ratio along with FEV1 and FVC values in both the groups through spirometry and to compare changes in the number of COPD exacerbations in both the groups (through measuring FDI of episodes each month). |