| CTRI Number |
CTRI/2024/06/069090 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Siddha Other (Specify) [pilot study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on effectiveness of Bringaraja thailam for the management of sooli kanam |
|
Scientific Title of Study
|
An pilot study to assess the effectiveness of Bringaraja thailam for the management of childhood bronchial asthma |
| 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 Karthika Prakasan |
| Designation |
PG scholar |
| Affiliation |
Research and hospital, National institute of siddha |
| Address |
Ayothidoss Pandithar hospital
Department of kuzhanthai maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram TAMIL NADU 600047 India |
| Phone |
8075114626 |
| Fax |
|
| Email |
karthikaprakasan268@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Vennila |
| Designation |
Associate Professor |
| Affiliation |
National institute of siddha |
| Address |
Ayothidoss Pandithar hospital
Department of Kuzhandhai Maruthuvam National Institute of Siddha
Tambaram Sanatorium
Chennai
Kancheepuram TAMIL NADU 600047 India |
| Phone |
9789093986 |
| Fax |
|
| Email |
gvennils@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Karthika Prakasan |
| Designation |
PG scholar |
| Affiliation |
National institute of siddha |
| Address |
Ayothidoss Pandithar hospital
Department of kuzhanthai maruthuvam
National Institute of Siddha
Tambaram sanatorium
Chennai
Kancheepuram TAMIL NADU 600047 India |
| Phone |
8075114626 |
| Fax |
|
| Email |
karthikaprakasan268@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar hospital
National Institute of siddha
Tambaram sanatorium
Chennai 600047
Kancheepuram district
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
yothidoss Pandithar Hospital National Institute of siddha Tambaram Sanatorium Chennai 47 |
| 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 Karthika Prakasan |
Ayothidoss pandithar hospital |
Room no 16 Department of Kuzhanthai Maruthuvam National institute of siddha Tambaram sanatorium
Chennai
Kancheepuram
Tamilnadu
India
Kancheepuram TAMIL NADU |
8075114626
karthikaprakasan268@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| he 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: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bringaraja thailam as internal medicine |
Ingredients
karisalai Eclipta alba
Gingelly oil
ROUTE OF ADMINISTRATION
Internal
DOSAGE
6 to 8 years 0.5 ml
9 to 12 years 1 to 1.5 ml
DURATION
48 DAYS |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Children of both sex in the age group of 6 to 12 years
2 Is diagnosed with asthma by following the Global Initiative for Asthma (GINA) guidelines and St Georges respiratory questionnaire
3 Children having FEV1 greater than 60 percentage TO less than 80 percentage
4 Patient willing to co-operate for spirometry test
5 Parent willing to sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
1 H/O Pulmonary tuberculosis
2 H/O Bronchiectasis
3 Subject unable to do Spirometry
4 Any other serious illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of the trial drug will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline |
Effectiveness of the trial drug will be assessed by spirometry before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the symptoms assessed by GINA Global Initiative for Asthma Guidelines 2022 and St Georges Respiratory questionnaire
|
Before and after treatment |
|
|
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 2 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 Bringaraja thailam. 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 due to mouth breathing. It can be closely compared withchildhood 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 10 patients within age limit of 6 to 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 will be assessed by spirometry by Comparing the values of forced expiratory volume after treatment from baseline and also assess the improvement in the symptoms by GINA Global Initiative for Asthma Guidelines 2022 and St. Georges respiratory questionnaire.
|