| CTRI Number |
CTRI/2017/04/008443 [Registered on: 28/04/2017] Trial Registered Prospectively |
| Last Modified On: |
28/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL TRAIL ON SAUVARCHALADI CHOORNA AND PADMAKADI HERBAL NEBULIZATION IN THE MANAGEMENT OF CHILDHOOD BRONCHIAL ASTHMA (TAMAKA SHWASA) |
|
Scientific Title of Study
|
CLINICAL STUDY ON SAUVARCHALADI CHOORNA AND PADMAKADI HERBAL NEBULIZATION IN THE MANAGEMENT OF TAMAKA SHWASA W.S.R TO CHILDHOOD 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 |
SUJATA BANIK |
| Designation |
MD SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA, WAGHODIA, LIMDA, GUJRAT. 391760
PARUL INSTITUTE OF AYURVEDA, WAGHODIA, LIMDA, GUJRAT. 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9574636895 |
| Fax |
|
| Email |
drsujata13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUNIL P CHANGLE |
| Designation |
professor |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA, WAGHODIA, LIMDA, GUJRAT. 391760
PARUL INSTITUTE OF AYURVEDA, WAGHODIA, LIMDA, GUJRAT. 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9687613916 |
| Fax |
|
| Email |
sunilchangle16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUNIL P CHANGLE |
| Designation |
professor |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA, WAGHODIA, LIMDA, GUJRAT. 391760
PARUL INSTITUTE OF AYURVEDA, WAGHODIA, LIMDA, GUJRAT. 391760
Rajkot
GUJARAT
391760
India |
| Phone |
9687613916 |
| Fax |
|
| Email |
sunilchangle16@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of ayurveda |
|
|
Primary Sponsor
|
| Name |
parul institute of ayurveda |
| Address |
PARUL INSTITUTE OF AYURVEDA,parul university WAGHODIA, LIMDA, GUJRAT. 391760 |
| 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 |
| SUJATA BANIK |
parul ayurvedic hospital |
PARUL INSTITUTE OF AYURVEDA,
kaumarabhrtiya dept
opd no 112
WAGHODIA, LIMDA, GUJRAT. 391760
Vadodara
GUJARAT |
9574636895
drsujata13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
BRONCHIAL ASTHMA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
SAUVARCHALADI CHOORNA, PADMAKADI HERBAL NEULIZATION |
both formulations will be given in a single armed traiprocedure during attacks of Asthma.
dose will be calculated according to youngs formula
choorna will be given three time in day for 12 wks
nebulization will be given when ever the patient gets an attack of Asthma during the total course of study
route of administration for choorna will be oral and for nebulization will be nasal |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
classical symptoms of childhood Asthma like wheezing, shotness of breath etc will be included.
patients who are known case of Bronchial Asthma. |
|
| ExclusionCriteria |
| Details |
severe asthma cases with complications like suspected infections, heart diseases, pneumonia, airway lesions etc.
chronic debilating diseases like TB, AIDS, endocrine complaints etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCES THE EPISODES OF ASTHMA ATTACK |
12 weeks
follow up monthly once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCES COMMON CHIEF COMPLAINTS OF ASTHMA |
12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1 |
|
Date of First Enrollment (India)
|
01/05/2017 |
| 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="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bronchial asthma is a disease characterized by
an increased responsiveness of the airways to various stimuli. It manifests by
widespread narrowing of the airways causing paroxysmal dyspnea, wheezing or
cough. The approximated estimation suggests the prevalence
of 334 million cases globally. This alarmingly high prevalence is found especially
among children, because of changes in life style, rapid industrialization and
increase in air pollution etc. In Ayurveda proper nebulization therapy has been not explained but the process
of dhumpana & dhoopana nasya may be analogous in some extent. Thus, this
work gives the glimpse of concept of inhalation therapy described in Ayurvedic
classics & establishment of newer concept of drug administration route i.e;
through nebulization along with Sauvarchaladi choorna will be assessed in
patients of Tamaka Shwasa.
|