| CTRI Number |
CTRI/2025/04/083823 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Randomised controlled trial to explore the efficacy of adjuvant homoeopathy in the treatment of COPD patients: an interventional, prospective study |
|
Scientific Title of Study
|
Randomized control Trial to explore the efficacy of adjuvant homoeopathy in the treatment of COPD patients: an interventional, prospective study |
| 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 SUDHIR BATRA |
| Designation |
PhD Scholar |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Center Homoeopathy University Jaipur |
| Address |
Dr. M.P.K. Homoeopathic Meclical College, Hospital and Research Center, Jaipur,
Homoeopathy University, Plot No. 10,11,12
Saipura-Sanganer, Jaipur-302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
|
| Fax |
|
| Email |
drsbatra2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR ASHOK YADAV |
| Designation |
Professor Practice of Medicine |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre Homoeopathy University Jaipur |
| Address |
Dr. M.P.K. Homoeopathic Meclical College, Hospital and Research Center, Jaipur,
Homoeopathy University, Plot No. 10,11,12
Saipura-Sanganer, Jaipur-302029
Dr.MPK Homoeopathic Meclical College, Hospital and Research Center,
Homoeopathy University, Jaipur-302029
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829053664 |
| Fax |
|
| Email |
PMpg2724dept@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUDHIR BATRA |
| Designation |
CMO (SAG) Homoeopathy |
| Affiliation |
Directorate of AYUSH, Homoeopathic Wing, Government of Delhi |
| Address |
Directorate of AYUSH,
Homoeopathic Wing,
Government of Delhi,
B Block, Preet Vihar,
Delhi- 92
Directorate of AYUSH,
Homoeopathic Wing,
Government of Delhi,
B Block, Preet Vihar,
Delhi- 92
East
DELHI
110092
India |
| Phone |
9811304703 |
| Fax |
|
| Email |
drsbatra2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Directorate of AYUSH,
Homoeopathic Wing,
Government of Delhi,
B Block, Preet Vihar,
Delhi-92 |
|
|
Primary Sponsor
|
| Name |
Directorate of AYUSH, Homoeopathic Wing, Government of Delhi |
| Address |
Directorate of AYUSH,
Homoeopathic Wing,
Government of Delhi,
B Block, Preet Vihar,
Delhi-92 |
| Type of Sponsor |
Other [Government of Delhi, Directorate of AYUSH, Homoeopathic Wing] |
|
|
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 SUDHIR BATRA |
Government Dispensary, Directorate of AYUSH, Homoeopathic Wing, Government of Delhi |
Government Homoeopathic Dispensary,
Directorate of AYUSH,
Department of Health and Family welfare
Homoeopathic Wing,
Government of Delhi
North West
DELHI |
9811304703
drsbatra2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NHMC, Directorate of AYUSH, Homoeopathic Wing, Government of Delhi |
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 |
Homoeopathic Placebo as an adjunt to Standard treatment of COPD. All patients will take standard allopathic treatment of COPD. |
Homoeopathic Placebo as an adjunt to Standard treatment of COPD. All patients will take standard allopathic treatment of COPD. They will recieve add on Homoeopathic placebo. |
| Intervention |
Individualised Homoeopathic Medicine as an adjunt to Standard treatment of COPD. All patients will take standard allopathic treatment of COPD. |
Individualised Homoeopathic Medicine as an adjunt to Standard treatment of COPD. All patients will take standard allopathic treatment of COPD. They will recieve add on Homoeopathic treatment. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of COPD as per the latest GOLD guidelines.
FEV1 more than 50%
Willing to participate in the study and agree for treatment compliance.
Willingness by the patient to attend scheduled follow up visits and undergo study assessments
|
|
| ExclusionCriteria |
| Details |
Patients not giving consent.
Patients with co-morbidity.
Patients requiring oxygen therapy and/or hospitalization.
Pregnant or lactating mother.
Significant metabolic, gastrointestinal, neurological, psychiatric, or endocrine diseases, active malignancy.
Patients on any other medication except standard COPD regimen.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effect of Homoeopathic add on medicine to standard care treatment of COPD patients, To assess the effect on Spirometry score and to observe any reduction in exacerbation episodes, if any |
Nine months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in symptom scoring at baseline, and completion of treatment as per COPD Assessment Tool (CAT)
To assess the incidence of side effects in two groups
|
Nine months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/04/2025 |
| 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 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
|
All participants will be keep on taking standard allopathic care treatment. All COPD patients will be given add on Homoeopathic medicine ( or placebo, as the case may be) . At the end of study, both the groups will be analysed for variations, if any. The variations will be analysed in both the Homoeopathic and placebo groups to see the effect on primary and secondary outcomes. |