| CTRI Number |
CTRI/2015/03/005599 [Registered on: 04/03/2015] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical study of Pushkarmulaadi churna in ASTHMA |
|
Scientific Title of Study
|
A Comparative Clinical study of Pushkarmulaadi churna with Anupana Bheda in the Management of Tamak Shavas with special reference to 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 |
Dr R K Pareek |
| Designation |
HOD |
| Affiliation |
Desh Bhagat University |
| Address |
PG School of Ayurveda and Research , MGG
PG School of Ayurveda and Research , MGG
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
09416281568 |
| Fax |
|
| Email |
dbacandh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja khurana |
| Designation |
P.G. Scholar |
| Affiliation |
Desh Bhagat University |
| Address |
PG School of Ayurveda and Research , MGG
PG School of Ayurveda and Research , MGG
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
09466303035 |
| Fax |
|
| Email |
drpoojakhuranamalik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja khurana |
| Designation |
P.G. Scholar |
| Affiliation |
Desh Bhagat University |
| Address |
PG School of Ayurveda and Research , MGG
PG School of Ayurveda and Research , MGG
Jalandhar
PUNJAB
147301
India |
| Phone |
09466303035 |
| Fax |
|
| Email |
drpoojakhuranamalik@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Desh Bhagat University |
| Address |
Desh Bhagat University
PG school of Ayurveda and Research,MGG |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Desh Bhagat University |
Dept of Kayachikista,
PG school of Ayurveda and Research,MGG |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R K Pareek |
Desh Bhagat Hospital |
Kayachikitsa department,PG School of Ayurveda and research,Desh Bhagat Hospital,Mandi Gobindgarh,PUNJAB
Fatehgarh Sahib
PUNJAB |
9416281568
dbacandh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PG school of Ayurveda and Research,Desh Bhagat University,Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having signs and symptoms of Tamak Shavas(Cough, Shortness of
Breath,Expiratory wheeze etc.)., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pushkarmulaadi churna with honey as anupana |
Pushkarmulaadi churna with luek warm water in GpI and with honey in gp II and trial duration is 60 days in each group |
| Comparator Agent |
Pushkarmulaadi churna( Inula racemosa) |
Pushkarmulaadi churna with luke warm water in Gp I and with Honey in GP II and trial duration is 60 days in each group
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients willing for trial.
b) Both male and female patients of agebetween 16 years to 80 years.
c) Patients having signs and symptoms of Tamak Shavas(Cough, Shortness of
Breath,Expiratory wheeze etc.).
d) Night symptoms > twice per month.
e) Patients not having any state mentioned in exclusion criteria.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:-
a) Patients unwilling to participate in the trial.
b) Patients of age below 16 years and more than 80 years.
c) Alcoholics and drug abuses.
d) Pregnant and lactating women.
e) Severe cases of asthma with complication like suspected infections,large airway lesion,Status asthmatics etc.Cardiaccomplaints,other chronic disease T.B,AIDS,DiabetesMellitus,other systemic and endocrine complaints associated with any degree of asthma.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After completion of the trial period, the data obtained in both groups will be recorded, tabulated and statically analyzed using appropriate test |
After completion of the trial period, the data obtained in both groups will be recorded, tabulated and statically analyzed using appropriate test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| data obtained in both groups will be recorded |
data obtained in both groups will be recorded |
|
|
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)
|
15/09/2014 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL yet in trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Tamak
shavasa (bronchial asthma) is considered as main disease of
Pranvahastrotas
( Respiratory tract). Bronchial Asthma is characterized by Paroxysm of
dyspnoea accompanied by wheezing resulting from narrowing of Bronchial airways
by muscle spasm, mucosal swelling or viscid secretions. As stated by W.H.O.
100-150 million of global population are suffering from Bronchial Asthma. In
today stressfull modern urbanized living, incidence of Asthma is considerably
increasing. The rapid industrialization, increasing pollution and excessive
crowding are some of the factors responsible for the increase of Bronchial
Asthma Disease. In modern it is mainly treated with steroids that actually weakens the lungs when used for
long term and come with many other side effects such as dryness, candida or
yeast infection, lowered immunity, thinning of bronchiols rashes , Psoriasis
and many more. So there is need of safe and effective medicine in Ayurveda for
the Treatment and Management of Tamak Shvasa( Bronchial asthma). Pushkarmulaadi
churna is selected for trial. In one group Pushkarmulaadi Churna was given with
luke warm water and in another group
Pushkarmulaadi Churna was given with Honey. |