| CTRI Number |
CTRI/2017/07/009051 [Registered on: 17/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL STUDY TO ASSESS THE EFFICACY OF SHATYADI CHURNA WITH ERANDBHRUSTA HARITAKI CHURNA AND WITHOUT ERANDBHRUSTA HARITAKI CHURNA AS ANULOMAN IN TAMAK SHWASA (BRONCHIAL ASTHMA) |
|
Scientific Title of Study
|
A CLINICAL STUDY ON SHATYADI CHURNA WITH & WITHOUT ERANDBHRUSTA HARITAKI CHURNA AS ANULOMAN IN TAMAK SHWASA (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 |
NISHA M PRAJAPATI |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT AKHANDANAND AYURVEDIC COLLEGE |
| Address |
Upgraded department of Kayachikitsa
Government Akhandanand Ayurvedic College Bhadra Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
9016275596 |
| Fax |
|
| Email |
drnisha.1711@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUSTAK N SHAIKH |
| Designation |
I/C READER |
| Affiliation |
GOVERNMENT AKHANDANAND AYURVEDIC COLLEGE |
| Address |
Upgraded department of Kayachikitsa
Government Akhandanand Ayurvedic College Bhadra Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824440708 |
| Fax |
|
| Email |
mustakshaikh11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MUSTAK N SHAIKH |
| Designation |
I/C READER |
| Affiliation |
GOVERNMENT AKHANDANAND AYURVEDIC COLLEGE |
| Address |
Upgraded department of Kayachikitsa
Government Akhandanand Ayurvedic College Bhadra Ahmedabad
GUJARAT
380001
India
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824440708 |
| Fax |
|
| Email |
mustakshaikh11@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurvedic College, Bhadra Ahmedabad |
|
|
Primary Sponsor
|
| Name |
GOVT AKHANDANAND AYURVEDIC COLLEGE AND HOSPITAL AHMEDABAD AND MANIBEN AYURVED HOSPITAL AHMEDABAD |
| Address |
OPD of Kayachikitsa Department Govt Akhandanand Ayurvedic Hospital Bhadra Ahmedabad Maniben Ayurvedic Hospital Asarva Ahmedabad |
| 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 |
| NISHA M PRAJAPATI |
GOVT AKHANDANAND AYURVEDIC COLLEGE |
OPD NO. 9 Kayachikitsa Department Akhandanand Ayurvedic College Bhadra Ahmedabad 380001
Ahmadabad
GUJARAT |
9016275596
drnisha.1711@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
TAMAK SHWASA (BRONCHIAL ASTHMA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SHATYADI CHURNA ALONG WITH
ERANDBHRUSTA HARITAKI CHURNA AS ANULOMAN ORALLY |
15 Patients will be taken in group A and will be treated with SHATYADI CHURNA in following dose and duration Dose:3 gms 4 times a day with Sukhoshna jala and Duration: 4 weeks and
ERANDBHRUSTA HARITAKI CHURNA in following Dose:2 gms twice in a day with Sukhoshna jala and Duration: 4 weeks
|
| Comparator Agent |
SHATYADI CHURNA ORALLY |
15 Patients will be taken in group B and will be treated with only SHATYADI CHURNA in following dose and duration Dose:3 gms 4 times a day with Sukhoshna jala and Duration: 4 weeks
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients present with classical sign & symptoms of Tamak shwasa like Shwasakastata(Breathlessness), Ativege Kasate(Frequent bouts of coughing), Ghurghurukam(wheezing), Peenasa(Coryza), Asino Labhate Saukhyam(Comfort in sitting posture), Lalate Sweda, Vishushkashyata(Dryness of mouth) |
|
| ExclusionCriteria |
| Details |
Asthma due to cardiac origin
Pathologic conditions like Tuberculosis,Cor pulmonale,Emphysema,malignancy,tumour
Patients having disease like Hypertension,Diabetes Mellitus,severe Anaemia
Patients with severity of more than 2 attacks per day |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shwasakastata(Breathlessness),Ativege Kasa(Frequent bouts of coughing),Ghurghurukam (Wheezing),Peenasa(Coryza), Asino Labhate Saukhyam(Comfort in sitting posture),Dryness of mouth,P.E.F.R |
4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shwasakastata(Breathlessness),Ativege Kasa(Frequent bouts of coughing),Ghurghurukam (Wheezing),Peenasa(Coryza), Asino Labhate Saukhyam(Comfort in sitting posture),Dryness of mouth,P.E.F.R |
4 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
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized parallel group trial in department of Kayachikitsa OPD at Government Akhandanand Ayurvedic college and hospital and Maniben Ayurved hospital,Ahmedabad Gujarat. Dealing with the treatment of disease Tamak Shwasa(Bronchial Asthma) ,Acharya Charak has mentioned that it should be treated with the drugs having properties like kaphashamak ,vatashamak, ushna and vatanuloman.This both the drugs are ushna and kaphavatashamak.In addition Erandbhrusta haritaki is vatanuloman drug.Therefore in this study,Shatyadi churna and Erandbhrusta haritaki churna have been selected for clinical trial. This study is trial to evaluate the efficacy of Shatyadi churna in a Dose of 3 gms 4 times in a day in empty stomach with lukewarm water and Duration of 4 weeks along with Erandbhrusta haritaki churna in a Dose of 2 gms 2 times in a day before meal with lukewarm water and Duration of 4 weeks in 15 patients in GROUP A and only Shatyadi churna with same Dose and Duration as given in group A, in 15 patients with GROUP B in Bronchial Asthma.
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