CTRI Number |
CTRI/2022/11/047659 [Registered on: 25/11/2022] Trial Registered Prospectively |
Last Modified On: |
21/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
SOOLIKANA NEI FOR WHEEZING IN CHILDREN |
Scientific Title of Study
|
Phase II Non Randomised Clinical Study On Sooli Kanam (Bronchial Aathma) In Children WITH THE EVALUATION OF SIDDHA TRIAL DRUG SOOLI KANA NEI |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Komalesvaran R |
Designation |
PG Scholar |
Affiliation |
Government Siddha medical college |
Address |
Room no 25
Department of PG Kuzhanthai maruthuvam
Government Siddha medical college
Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
7373942096 |
Fax |
|
Email |
komalesvaran2@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr B Malarvizhi MDs |
Designation |
HOD and Professor |
Affiliation |
Government Siddha medical college |
Address |
Room no 25
Department of PG Kuzhanthai maruthuvam
Government Siddha medical college
Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
9444487063 |
Fax |
|
Email |
malarvizhiisha@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Komalesvaran R |
Designation |
PG Scholar |
Affiliation |
Government Siddha medical college |
Address |
Room no 25
Department of PG Kuzhanthai maruthuvam
Government Siddha medical college
Arumbakkam
Chennai TAMIL NADU 600106 India |
Phone |
7373942096 |
Fax |
|
Email |
komalesvaran2@gmail.com |
|
Source of Monetary or Material Support
|
Government Siddha medical college Arumbakkam |
|
Primary Sponsor
|
Name |
Government Siddha medical college |
Address |
No 6 Anna arch Road
NSK nagar
Arumbakkam
chennai 600106 |
Type of Sponsor |
Government medical college |
|
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 Komalesvaran R |
Government Siddha medical college |
Room no 25
Department of PG Kuzhanthai maruthuvam
NSK Nagar
Arumbakkam Chennai TAMIL NADU |
7373942096
komalesvaran2@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: J454||Moderate persistent asthma, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
NIL |
Intervention |
Sooli Kana Nei |
Sooli Kana Nei
Dosage 2-5 grams bd
Duration 14days |
|
Inclusion Criteria
|
Age From |
3.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
Cough without expectoration
Dyspnea
Running nose
Chest tightness
Wheezing |
|
ExclusionCriteria |
Details |
Primary complex
Hypersensitivity Pneumonitis
Lung Abscess
Cystic fibrosis
Bronchiolitis |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
It is assesed by reduction in clinical symptoms and Modified Asthma Scale before and after treatment |
14 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
It is assessed by comparing the safety parameters before and after treatment.
Along with this investigational changesof reduction in ESR level, Eosinophil counts, WBC and increase level of HB |
14 days |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/12/2022 |
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="0" Days="0" |
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)?
Response - NO
|
Brief Summary
|
This is a single Non Randomized open Clinical Trial to study the safety and efficacy of Siddha trial drug Sooli kana nei (internal) is to be given about 2-5grams twice a day for 14 days to 40 patients.Clinical Trial conducted after conducting Pre Clinical oral toxicity study.The trial drug Sooli kana nei has mentioned in Pillai pini Maruthuvam Part 2.During the trial study related data will be recorded and documented.After the completion of trial all data will be statistically analysed. |