| CTRI Number |
CTRI/2019/10/021481 [Registered on: 01/10/2019] Trial Registered Prospectively |
| Last Modified On: |
22/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare Drug Utilization and effects between Ayurveda and Allopathy treatment in patients with Bronchial Asthma. |
|
Scientific Title of Study
|
Comparative study of Drug Utilization and effects in Ayurveda and Conventional treatment in Bronchial Asthma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANANYA A NAYAK |
| Designation |
STUDENT |
| Affiliation |
MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
DEPARTMENT OF PHARMACY PRACTICE, MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
7975827672 |
| Fax |
|
| Email |
an17.ananya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KANAV KHERA |
| Designation |
ASSISTANT PROFESSOR, SENIOR SCALE |
| Affiliation |
MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
DEPARTMENT OF PHARMACY PRACTICE, MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
7889271828 |
| Fax |
|
| Email |
kanav.khera@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ANANYA A NAYAK |
| Designation |
STUDENT |
| Affiliation |
MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
DEPARTMENT OF PHARMACY PRACTICE, MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL
KARNATAKA
576104
India |
| Phone |
7975827672 |
| Fax |
|
| Email |
an17.ananya@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PHARMACY PRACTICE, MANIPAL COLLEGE OF PHARMACEUTICAL SCIENCES, MADHAV NAGAR, MANIPAL, KARNATAKA 576104 |
| DIVISION OF AYURVEDA, CIMR, MANIPAL ACADEMY OF HIGHER EDUCATION, MANIPAL, KARNATAKA 576104 |
| KASTURBA HOSPITAL, UDUPI-HEBRI ROAD, MADHAV NAGAR, MANIPAL, KARNATAKA 576104
|
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| ANANYA A NAYAK |
KASTURBA HOSPITAL, MANIPAL |
DEPARTMENT OF RESPIRATORY MEDICINE, 1ST FLOOR, NEW OPD BLOCK, KASTURBA HOSPITAL, UDUPI-HEBRI ROAD, MADHAV NAGAR, MANIPAL, KARNATAKA 576104
Udupi
KARNATAKA |
7975827672
an17.ananya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Out patients visiting the Respiratory and Ayurveda departments. |
|
| ExclusionCriteria |
| Details |
1. Patients with cardiovascular disease (Cardiac arrest, Arrhythmia, Congenital Heart Disease, Stroke).
2. Patients with hepatic and renal impairment.
3. Pregnant and lactating women.
4. Patients with neurological impairment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Drug utilization patterns and effects of treatment in patients with Bronchial Asthma will be assessed. |
Data will be collected for 12 months which will be followed by organizing and analysis of the data collected for 2 months and then 1 month will be used to prepare a report. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life of patients will be assessed along with the direct cost of therapy per patient. |
Data will be collected for 12 months which will be followed by organizing and analysis of the data collected for 2 months and then 1 month will be used to prepare a report. |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
07/10/2019 |
| 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="3"
Days="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective observational study which compares the
Drug Utilization patterns and effects in Ayurveda and Conventional treatment in
patients with Bronchial Asthma which will be conducted in India in Kasturba
Hospital, Manipal in a minimum of 250 patients for the approved duration of
study. The primary objective of this study is to study the Drug Utilization patterns
and effects of therapy in Ayurveda and Conventional treatment in patients with
Bronchial Asthma and the secondary objective of this study is to study the
Quality of Life among Bronchial Asthma patients along with assessment of direct
cost of therapy per patient. The drug utilization patterns will be compared
among patients of out-patient department in Ayurveda and Respiratory medicine separately.
The information obtained will be noted in a suitable designed CRF. Follow-up
will be done on the visit or by contacting the patient. The Quality of life
will be measured using Asthma Quality of Life Questionnaire (AQLQ), a
standardized widely available and validated instrument to assess quality of
life in Asthmatic patients. Efficacy will be assessed according to the domains
in the Quality of Life Questionnaire. As a routine investigation, the direct
cost burden will be compared between both the therapies and will also be
calculated for every patient. The confidentiality of the patient data collected
will be duly respected and the name of the patient will not be noted under any
circumstance. |