| CTRI Number |
CTRI/2021/11/037807 [Registered on: 03/11/2021] Trial Registered Prospectively |
| Last Modified On: |
23/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of blood removal therapy followed by bharangi extract nebulization and bharangi extract nebulization in bronchial asthma |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the combined effect of siravyadha followed by bharangi arka nebulization with the standard group bharangi arka nebulization in tamaka 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 |
Dr Monika Thakan |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9416842630 |
| Fax |
|
| Email |
pg19147@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Thakan |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9416842630 |
| Fax |
|
| Email |
pg19147@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
DrAshviini KumarM |
| Designation |
Professor and Head of Department Of Panchakarma |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9448705660 |
| Fax |
|
| Email |
ashvinipanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
College Phone : 08172256460
Email : sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda and Hospital Hassan |
| Address |
SDM College of Ayurveda and Hospital BM Road Thaniruhalla Hassan Karnataka India
College phone: 08172256460
Email: college@sdmcahhassan.org |
| 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 |
| DrMonika |
In patient Department of panchakarma |
Department of panchakarma OPD no. 5 ,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA |
9416842630
pg19147@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A randomized comparative clinical study |
40 Subjects fulfilling diagnostics and inclusion criteria will be selected by convenience sampling method and will be treated in two groups of 20 subjects each Group A: 20 subjects will be treated with siravyadha followed by bharangi arka nebulization after 15 minutes Group B: 20 Subjects will be treated with bharangi arka nebulization |
| Intervention |
A randomized comparative clinical study |
40 Subjects fulfilling diagnostics and inclusion criteria will be selected by convenience sampling method and will be treated in two groups of 20 subjects each
Group A: 20 subjects will be treated with siravyadha followed by bharangi arka nebulization after 15 minutes
Group B: 20 Subjects will be treated with bharangi arka nebulization |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild and moderate grade of Bronchial Asthma as per GINA
2. Subjects with Hb more than 10 gm percent
3. Subjects with normal clotting and bleeding time |
|
| ExclusionCriteria |
| Details |
1. Subjects who are known case of Tuberculosis Emphysema COPD
2. Subjects who are known case of Cardiac Diseases
3. Subjects who are known case of HIV and HBsAg
4. Subjects with uncontrolled Diabetes Mellitus and Hypertension.
5. Subjects with Bleeding Disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Samyak siravyadha lakshanas will be observed:
1. Laghava
2. Vedana shanti
3. Vyadhirvega kshaya
4. Mana prasada |
Measures will be assessed by giving proper gradings before treatment, after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in subjects of Group A
In Group B, measures will be assessed before treatment and 15 minutes after nebulization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The effect of the therapy will be assessed on the basis of relief of following signs and symptoms of Tamaka Shwasa which will be assigned suitable scores(GINA scale):
1. Gurukuraka
2. Kasa
3. Teevravega Shwasa
4. Peenasa
5. Shushkasya |
Measures will be assessed by giving proper gradings before treatment, after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in subjects of Group A
In Group B, measures will be assessed before treatment and 15 minutes after nebulization |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/12/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Yet to initiate patient enrolment |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label, double arm randomized prospective clinical trial to evaluate the combined effect of siravyadha followed by bharangi arka nebulization with the standard group bharangi arka nebulization in Tamaka Shwasa( Bronchial Asthma) that will be conducted in India. Primary outcome measures will be laghava, vedana shanti, vyadhirvega kshaya, mana prasada and secondary outcome measures will be assessed on the basis of relief in the signs and symptoms of Tamaka Shwasa, which will be assigned suitable scores(GINA) Time points will be before treatment, immediately after siravyadha, 15 minutes after siravyadha, before nebulization, 15 minutes after nebulization in the subjects of group A. While in group B, primary and secondary measure will be assessed before treatment, 15 minutes after nebulization. |