| CTRI Number |
CTRI/2018/04/013336 [Registered on: 18/04/2018] Trial Registered Prospectively |
| Last Modified On: |
18/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Role of Shirishadi kwath in management of Asthma |
|
Scientific Title of Study
|
Clinicopathological study of tamak shwas and therapeautic evaluation of an Ayurvedic formulation in its management. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Baishno gupta |
| Designation |
P.g. scholar |
| Affiliation |
Rishikul campus UAU Haridwar |
| Address |
Rishikul campus uttrakhand Ayurveda university Haridwar
Department of Roga nidan UAU Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7004083894 |
| Fax |
|
| Email |
drbaishnogupta1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay kumar singh |
| Designation |
professor |
| Affiliation |
Rishikul campus UAU Haridwar |
| Address |
Roga nidan department Rishikul campus uttrakhand Ayurveda university Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9415284453 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay kumar singh |
| Designation |
professor |
| Affiliation |
Rishikul campus UAU Haridwar |
| Address |
Roga nidan department Rishikul campus uttrakhand Ayurveda university Haridwar
Roga nidan department Rishikul campus uttrakhand Ayurveda university Haridwar
UTTARANCHAL
249401
India |
| Phone |
9415284453 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Registrar UAU Harrawala Dehradun |
|
|
Primary Sponsor
|
| Name |
Campus Director |
| Address |
UAU Rishikul campus, Haridwar |
| Type of Sponsor |
Government 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 |
| Sanjay Kumar Singh |
Rishikul Campus and Hospital |
Deptt of Roga nidan Rishikul Campus UAU
Hardwar
UTTARANCHAL |
9415284453
drsanjaysingh1970@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee uau rishikul campus haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patient diagnosed with Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Shirishadi kwath |
50 ml twice a day after meal for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having the classical symtoms of tamaka shwasa will be included |
|
| ExclusionCriteria |
| Details |
1.Patients of cardiac asthma, COPD, emphysema, post tubercular lung fibrosis.
2.Patients having any other systemic disorder like diabetes, HTN, tuberculosis etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Trail Yet to be Started |
June 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the trial have not started yet |
the trial have not started yet |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/04/2018 |
| 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="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
minimum 40 patients of either sex will be registered between the age group of 18 to 70 years from the pg deptt of rishikul campus Haridwar on the basis of having classical symptoms of tamak shwasa the investigation will be made on the basis of requirement.the patient will be advice to take shirishadi kwath 50 ml twice a day after meal for 60 days. The objective assesment will be done on the basis of change in clinical findindgs. Assasment of the patient will be done at the interval of 15 days and the follow up will be done after completion of the study at 15th and 30th day.observation will be done on the basis of change in symptom of tamak swasa laboratory parameter and pulmonary function tes,t before during and after completion of the study. |