| CTRI Number |
CTRI/2024/04/066240 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment of bronchial asthma with less known homoeopathic medicine |
|
Scientific Title of Study
|
A study to assess the effectiveness of
Homoeopathic lesser-known medicines Asclepias
Tuberosa, Hydrocyanicum Acidum, Eriodyction
Californicum in the treatment of cases of
Bronchial Asthma
|
| 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 Yashaswi Choudhary |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department Of Practice Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
7014777157 |
| Fax |
|
| Email |
Tophomeopaths@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Yadav |
| Designation |
Professor |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department Of Practice Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829053664 |
| Fax |
|
| Email |
PMpg2724dept@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashaswi Choudhary |
| Designation |
PG Scholar |
| Affiliation |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department Of Practice Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
7014777157 |
| Fax |
|
| Email |
Tophomeopaths@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital And Research Centre Collegiate Hospital Of Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr M P K Homoeopathic Medical College Hospital and Research Centre |
| Address |
Homoeopathy University Plot No 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| 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 Yashaswi Choudhary |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department Of Practice Of Medicine Dr M P K Homoeopathic Medical College Hospital And Research Centre A Constituent College Of Homoeopathy University 10 11 12 Ward No 36 Saipura Sanganer Jaipur Rajasthan 302029
Jaipur
RAJASTHAN |
7014777157
tophomeopaths@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asclepias Tuberosa
|
Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M, 50M and CM as per the case and Hahnemannian guidelines of Organon of Medicine in the form of globules of 40 numbers, Dose and Repetition as per need of the case reassessment at the end of 3 month |
| Comparator Agent |
Eriodyction Californicum |
Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M, 50M and CM as per the case and Hahnemannian guidelines of Organon of Medicine in the form of globules of 40 numbers, Dose and Repetition as per need of the case reassessment at the end of 3 month |
| Comparator Agent |
Hydrocyanicum Acidum |
Homoeopathic Medicine shall be given orally in any potency 6c, 30c, 200c, 1M, 10M, 50M and CM as per the case and Hahnemannian guidelines of Organon of Medicine in the form of globules of 40 numbers, Dose and Repetition as per need of the case reassessment at the end of 3 month |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes of all religion
Diagnosed cases of bronchial asthma taking conventional or other treatment seeking homoeopathic treatment
New cases presenting with symptoms of bronchial asthma
Cases giving consent for study
|
|
| ExclusionCriteria |
| Details |
Patients with other severe systemic illness
Patients not giving consent for study
Patient pursuing other treatment and are not willing to leave it
Pregnant females and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained ( pre and post treatment and post treatment of both group) from the Asthma quality of life Questionnaire (AQLQ) |
Pre Score Will Be Taken At Baseline Of Treatment And Post Score Will Be Assessed At The End Of 12 Months Using Asthma Quality Of Life Questionnaire (Aqlq) Score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess The Effectiveness Of Homoeopathic Lesser Known Medicines Asclepias Tuberosa, Hydrocyanicum Acidum, Eriodyction Californicum In The Treatment Of Cases Of Bronchial Asthma
To assess the extent of improvement using AQLQ |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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 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
|
AIM
To assess effectiveness of lesser known homoeopathic
medicines Asclepias
tuberosa Hydrocyanicum acidum Eriodictyon californium in cases of bronchial
asthmaOBJECTIVES To see the effectiveness of
lesser known homoeopathic medicines Asclepias tuberosa in the cases of Bronchial asthma and to assess
the extent of improvement using AQLQ To see the effectiveness of
lesser known homoeopathic medicines Hydrocyanicum
acidum in the cases of Bronchial
asthma and to assess the extent of improvement using AQLQ To see the effectiveness of
lesser known homoeopathic medicines Eriodictyon californium in the cases of Bronchial
asthma and to assess the extent of
improvement using AQLQ
|