| CTRI Number |
CTRI/2019/12/022527 [Registered on: 27/12/2019] Trial Registered Prospectively |
| Last Modified On: |
23/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Swasakudori maathirai for Childhood Asthma |
|
Scientific Title of Study
|
Clinical Evaluation of Swasakudori Maathirai for
the management of Soolikanam (Childhood Asthma)
in Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivasan C |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 9,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7639712589 |
| Fax |
22381314 |
| Email |
Csrinivas7639@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vennila K |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 9,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9789093986 |
| Fax |
22381314 |
| Email |
Gvennils@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivasan C |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 9,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7639712589 |
| Fax |
22381314 |
| Email |
Csrinivas7639@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital,National Institute of Siddha,Tambaram Sanatorium |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
Ayothidoss Pandithar Hospital,National Institute of Siddha,Tambaram Sanatorium |
| 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 C Srinivasan |
Ayothidoss Pandithar Hospital,National Institute of Siddha |
Room no 9,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,Chennai
Kancheepuram
TAMIL NADU |
7639712589
22381314
Csrinivas7639@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: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Ni |
| Intervention |
Swasakudori Maathirai for the management of Soolikanam(Childhood Asthma) |
Swasakudori Maathirai for the management of Soolikanam(Childhood Asthma)Dosage:5-7 years:45 mg(bds)
8-12 yeras:65 mg(bds)
Adjuvant:Thalisapathiri kudineer |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Cough,Wheezing,Tightness of chest,Shortness of breath,Abdominal bloating,Loss of appetite |
|
| ExclusionCriteria |
| Details |
Haemoptysis,Active Primary complex,Congenital Heart diseases,Pneumonia, Any other serious illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the trial drug is measured by peak expiratory flow meter |
Fourty Sixth day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the recurrence of the disease and improvement in the quality of life of children
Improvement in clinical symptoms |
Fourty sixth day |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
29/12/2019 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an Interventional study in which 10 childrenwith symptoms like cough ,wheezing ,Tightness of chest will be selected based on inclusion and exclusion criteria.After enrolling the patients in the study Swasakudori Maathirai 45 mg or 65 mg will be given twice a day for 45 days.After 45 days patient wil be sked to absence of clinical signs and symptoms of childhood Asthma |