| CTRI Number |
CTRI/2022/06/043567 [Registered on: 29/06/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Swasakudori Mathirai for childhood bronchial asthma |
|
Scientific Title of Study
|
An open non randomized single arm single centric clinical trial to determine the effectiveness of Swasakudori Mathirai in the management of Sooli Kanam(childhood asthma) in children. |
| Trial Acronym |
ESMCHI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrBIlakkiya Gandhi |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 9,Department of kuzhandhai Maruthuvam,
National Institute of Siddha, Tambaram Sanatorium
Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
7299627481 |
| Fax |
|
| Email |
ilakkiyabsms.96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshi Sundaram MDS PhD |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
TAMIL NADU
60047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Meenakshi Sundaram MDS PhD |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
Room No 9, Department of Kuzhandhai Maruthuvam, National Institute of Siddha, Tambaram Sanatorium
Kancheepuram
TAMIL NADU
60047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar
Hospital,National Institute of siddha Tambaram Sanatorium,Chennai |
| 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 B Ilakkiya Gandhi |
Ayothidoss Pandithar Hospital |
National Institute of Siddha, Tambaram Sanatorium, Chennai
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
7299627481
ilakkiyabsms.96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Swasakudori mathirai |
Swasakudori mathirai dosage- 6-7years-90mg tablet,8-12years -130mg tablet with Thalisapathiri kudineer 6-7years-20ml,8-12years-30ml twice a day for 48 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
children with minimum 3-4 clinical symptoms of bronchial asthma may be included,
1.Cough
2.Wheezing
3.Tightness of chest
4.Abdominal bloating, shortness of breath.
5.Peak expiratory flow rate more than 50%(mild, moderate exacerbation)
|
|
| ExclusionCriteria |
| Details |
1.Peak expiratory flow rate less than 50%(severe exacerbation)
2.Congenital heart diseases
3.Pneumonia
4.H/o pulmonary tuberculosis
5.Any other serious illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY OUTCOME:
Effectiveness of the trial drug is measured by peak expiratory flow meter. |
Screening - 3 months
Patient Enrolment - 3 months
Trial Drug - 4 months
Data Analysis - 1 month
Follow up - 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction of clinical symptoms by using PASS SCORE.
|
fourty ninth day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2022 |
| Date of Study Completion (India) |
16/06/2023 |
| 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
Modification(s)
|
published on 13 September 2023
title-Efficacy OF Swasakudori mathirai-A Siddha formulation for the management of suvasakaasam:A review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
INTRODUCTION: This is an open non randomized clinical trail to determine the effectiveness of siddha herbal formulation Swasakudori Mathirai. Sooli Kanam has been described in the siddha literatures as the diseases frequently occuring in children . According to siddha texts, It is characterized by prolonged expiration and expiratory wheeze, prolonged cough, abdominal bloating and discomfort du to mouth breathing. It can
be closely compared with childhood Asthma. Asthma is a chronic inflammatory disease characterized by airway
obstruction, airway hyper responsiveness manifest as wheeze, cough, shortness of
breath and chest tightness. .Asthma tends to affect about 10% children
globally. Recent data have shown that asthma continues to affect 6 million
school aged children with approximately half of these children experiencing asthma attack
each year. MATERIALS AND METHODS: A total of 30 patients within age limit of 3-12 years
willing to participate in the study by signing consent and assent form will be
enrolled in the study. Both male and female children are included. RESULTS AND DISCUSSIONS: Effectiveness of the trial drug
is measured by peak expiratory flowmeter. Reduction of clinical
symptoms by using PASS SCORE. And the results will be statistically analysed. |