| CTRI Number |
CTRI/2023/03/050174 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Krishnadi Churna in Tamaka Shwasa WSR to Bronchial Asthma |
|
Scientific Title of Study
|
A Clinical study on the efficacy of Krishnadi churna in 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 Amber |
| Designation |
MD(Ay)Scholar |
| Affiliation |
Government Ayurvedic College |
| Address |
Government Ayurvedic College and Hospital, Deptt of Kayachikitsa, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
9065536123 |
| Fax |
|
| Email |
adilaamber24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College |
| Address |
Dept of Kayachikitsa
Government Ayurvedic College
Buddha Murti Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
Vijay.md09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay Bahadur Singh |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College |
| Address |
Dept of Kayachikitsa
Government Ayurvedic College
Buddha Murti Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
7004642738 |
| Fax |
|
| Email |
Vijay.md09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Kadamkuan, Patna |
|
|
Primary Sponsor
|
| Name |
Dr Amber |
| Address |
Government Ayurvedic College, Deptt of Kayachikitsa, Patna |
| Type of Sponsor |
Other [Self] |
|
|
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 Vijay Bahadur Singh |
Government Ayurvedic Hospital |
Deptt of Kayachikitsa, room no 09
Patna
BIHAR |
7004642738
Vijay.md09@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 |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krishnadi Churna, Reference: Bhaisajya Ratnavali adhyaay 16, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -unequal quantity of Madhu and ghrit), Additional Information: -Nil |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with signs and symptoms of Tamaka Shwasa for one or more years.
2.Patients with 3 or more of the following symptoms like a.ghurghurakam
b.nishtuyante kshanam sukham
c.Shwasa krichta
d.urah parshav peeda
e.aseeno labhte saukhyam.
3.Mild intermittent and persistent and moderate persistent asthma according to GINA classification |
|
| ExclusionCriteria |
| Details |
Severe persistent asthma according to GINA guidelines
TB, COPD, emphysema, infectious and complicated respiratory disease,
DM2 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms of Tamaka Shwasa |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in general health conditions |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/03/2023 |
| Date of Study Completion (India) |
31/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tamaka Shwasa is one of the challenging diseases which afflict the human race. It is vata-kaphaja disease originating from pittasthana and manifested through pranavaha srotasa. It can be correlated to Bronchial Asthma which is a chronic inflammatory disease of airways associated with hyperresponsiveness of the tracheobronchial tree with cardinal symptoms like wheezing, chest tightness, breathlessness and cough. After taking into consideration the seriousness of the disease , present study has been designed to evaluate the effect of Krishnadi churna in the management of Tamaka Shwasa with special reference to Bronchial Asthma |