| CTRI Number |
CTRI/2020/01/022961 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
25/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Shubhdeep Swasha Hara Pill in management of Shwasa roga (Asthma) |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Therapeutic Effect Of Shubhdeep Swasha Hara Pill In The Management Of Tamaka Shwasa W.S.R. 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 Akshiv Garg |
| Designation |
M.D. scholar |
| Affiliation |
Shubhdeep ayurved medical college and hospital |
| Address |
Shubhdeep ayurved medical college and hospital Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9034386281 |
| Fax |
|
| Email |
akshivgrg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AK Singh |
| Designation |
Professor |
| Affiliation |
Shubhdeep ayurved medical college and hospital |
| Address |
Shubhdeep ayurved medical college and hospital Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9300681233 |
| Fax |
|
| Email |
doctoraksingh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramakant Dwivedi |
| Designation |
Associate Professor |
| Affiliation |
Shubhdeep ayurved medical college and hospital |
| Address |
Shubhdeep ayurved medical college and hospital Indore
Indore
MADHYA PRADESH
452020
India |
| Phone |
9977524607 |
| Fax |
|
| Email |
ramakantdwivedi74@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Shubhdeep ayurved medical college hospital Indore |
| 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 |
| Dr Akshiv garg |
Shubhdeep ayurved medical college and hospital |
Village datoda khandwa road Indore
Indore
MADHYA PRADESH |
9034386281
akshivgrg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SHUBHDEEP SWASHA HARA PILL |
500 mg BID with lukewarm water |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients presenting with clinical features of Bronchial Asthma 2)Patients aged between 16-70 years with irrespective of gender 3)Peak Expiratory flow Rate more than 80 Lit/min & less than 300 Lit/min. |
|
| ExclusionCriteria |
| Details |
1)Patient aged less than 16 yr and more than 70 yrs 2)Peak Expiratory flow Rate less than 80 Lit/min are excluded 3)Asthma in pregnancy 4)Patients with severe attacks of Bronchial Asthma 5)Patients of Bronchial Asthma also suffering from other systemic disorders 6)The Bronchial asthma, associated with complications like emphysema and cor pulmonale. • |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Relief in breathlessness
2) Relief in cough
3) Relief in wheezing
4) Reduced frequency of attacks of bronchial asthma
5) Reduced duration of attack of asthma
6) Increase in Peak expiratory flow rate |
45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/01/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Tamaka Shwasa is a Pittasthana Samudbhava Pranavaha Sroto Vikara, in which Avarudha marga of Pranavayu due to morbid Kapha is the principle pathology involved. The vitiated Doshas afflicts Rasa Dhatu, involves Pranavaha srotas and produces the illness. Parallely, the signs & symptoms of Tamaka Shwasa are closely related to Bronchial Asthma.Vata and Kapha are the two key pathological factors involved in the Samprapti of Tamaka Shwasa. Ayurveda has got many time tested formulations for this condition. According to line of treatment of Tamaka Shwasa the Shubhdeep Swasha Hara Pill is selected which contain ingredients which have Vata-kapha hara and Ushna property. It was prepared to provide better, palatable & cheap remedy for patients of Tamaka Shwasa. This study is carried out in one group with pre-test and post-test design where in a minimum 30 patients suffering from Tamaka Shwasa of either sex between the age group of 16 to 70 years will be selected for the study. Final assessment of result is made on the basis of subjective & objective criteria. Appropriate statistical tests will be applied for subjective and objective parameters obtained.
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