| CTRI Number |
CTRI/2023/09/058061 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on Kana kudineer for wheezing (childhood asthma) |
|
Scientific Title of Study
|
Phase II Non randomized clinical study on Sooli kanam (Childhood bronchial asthma) in children with the evaluation of siddha trial drug kana kudineer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simal S |
| 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 |
8526533963 |
| Fax |
|
| Email |
gautamsimal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Shanmugapriya |
| Designation |
Lecturer |
| 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 |
9445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Simal S |
| 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 |
8526533963 |
| Fax |
|
| Email |
gautamsimal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
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 Simal S |
Government siddha medical college |
Room no 25 Department of Kuzhanthai maruthuvam
Chennai
TAMIL NADU |
8526533963
gautamsimal@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: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KANA KUDINEER (INTERNAL) |
Kana kudineer 15 to 30 ml
twice a day for 21 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Cough with expectoration
Dyspnea
Running nose or rhinitis
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 |
| Assesed by comparing the reduction in clinical symptoms & modified asthma scale before & after treatment |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed by comparing the safety parameters before & after treatment |
21 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)
|
26/10/2023 |
| 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
|
N/A |
|
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 Kana kudineer(internal) is to be given about 15 to 30 ml twice a day for 21 days.Clinical Trial conducted after conducting Pre Clinical oral Toxicity study.The Trial drug kana kudineer 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. |