| CTRI Number |
CTRI/2021/12/038922 [Registered on: 24/12/2021] Trial Registered Prospectively |
| Last Modified On: |
29/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Interventional] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Childhood Asthma with Shatyadi Churna |
|
Scientific Title of Study
|
A Comparative Clinical Study of Shatyadi Churna and Shunthi Pushkaramooladi Churna on Tamaka Shwasa (Bronchial Asthma) in Children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KADEK DWI MURAS MEI PERMATASARI |
| Designation |
MD Scholar |
| Affiliation |
ITRA Jamnagar |
| Address |
Department of Kaumarbhritya ITRA Ministry of AYUSH Government of India Jamnagar 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9986696047 |
| Fax |
|
| Email |
dr.kadekayurveda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V K Kori |
| Designation |
Associate Professor |
| Affiliation |
ITRA Jamnagar |
| Address |
Department of Kaumarbhritya ITRA 5th floor Institute building ITRA Jamnagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9409207485 |
| Fax |
|
| Email |
drvkkori@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K Kori |
| Designation |
Associate Professor |
| Affiliation |
ITRA Jamnagar |
| Address |
Department of Kaumarbhritya ITRA 5th floor Institute building ITRA Jamnagar Gujarat 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9409207485 |
| Fax |
|
| Email |
drvkkori@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Opposite Reliance Smart. Room no 532 in the 5th floor Department of Kaumarbhritya. Institute of Teaching and Research in Ayurveda (Institute of National Importance) Ministry of AYUSH, Government of India Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
ITRA |
| Address |
ITRA Jamnagar Opposite Reliance Smart Next to B Division Police Station Jamnagar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kadek Dwi Muras Mei Permatasari |
PG Hospital ITRA |
OPD no 15 PG Hospital of Institute of Teaching and Research in Ayurveda (institute of National Importance) Ministry of AYUSH , Goverment of India Jamanagar361008
Jamnagar
GUJARAT |
9986696047
dr.kadekayurveda@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:J45||Asthma. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatyadi Churna , Reference: Bharat Bhaishajya Ratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthi Pushkaramuladi Churna, Reference: A.H.Chi.1/66, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of bronchial asthma
Patients having signs and symptoms of Tamaka Shwasa |
|
| ExclusionCriteria |
| Details |
Children of either sex belonging to age ground below 5 years and above 16yrs
Evidence of requirement for intubation or had been hospitalized within or before 1 month
unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 4 weeks
Patients suffering from systemic illness such as TB HIV and other chronic debilitating disease
Evidence of active pulmonary disease other than asthma
Patients using any oral corticosteroids Astemizole Nedocromil Cromolyn and Long acting B agonist Ketotifen or Theophylline
|
|
|
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 |
Changes in the laboratory investigations for eg Hb TLC DLC ESR and AEC
Improvement in peak flow meter and spirometry parameter
Less frequency of Asthma attack and relief in dyspnea |
after 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical signs and symptoms of Tamaka Shwasa for eg Ghurghurakam Kricchrashaknoti bhasitum Kasa |
Day 0 and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
01/02/2022 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
This is an open labelled randomized comparative clinical trial to Compare the efficacy of Shatyadi Churna and Shunti Pushkarmooladi Churna on Tamaka Shwasa in Children, in which the medicine will be given through the oral route.There are two groups for the study purpose: Group A - Shatyadi Churna and in Group B - Shunti Pushkarmooladi Churna with 10 participants in each group with a duration of 8 weeks (56 days) with anupana as Honey. Follow up period for this study is 4 weeks for both the groups. |