| CTRI Number |
CTRI/2020/10/028491 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study on sooli kanam (Bronchial asthma) with evaluation of siddha trial drug - Kannaiku atthi nei in children |
|
Scientific Title of Study
|
PhaseII non randomized clinical study on sooli kanam (Bronchial asthma) with evaluation of siddha trial drug - Kannaiku atthi nei |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHOBANASHREE P |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college, chennai |
| Address |
Room no 25, Post graduate department of Kuzhanthai maruthuvam Government siddha medical college 6 Anna arch road NSk Nagar Arumbakkam chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9942912256 |
| Fax |
|
| Email |
dr.shobanashree301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Rani |
| Designation |
HOD and professor |
| Affiliation |
Government Siddha medical college, chennai |
| Address |
Room no 25, post graduate. department of Kuzhanthai maruthuvam Government siddha medical college 6 Anna arch road NSk Nagar Arumbakkam chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9442286863 |
| Fax |
|
| Email |
ranimoorthybsms19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Rani |
| Designation |
HOD and professor |
| Affiliation |
Government Siddha medical college, chennai |
| Address |
Room no 25, post graduate. department of Kuzhanthai maruthuvam Government siddha medical college 6 Anna arch road NSk Nagar Arumbakkam chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9442286863 |
| Fax |
|
| Email |
ranimoorthybsms19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college 6 Anna arch road NSk Nagar Arumbakkam chennai |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college chennai |
| Address |
Government siddha medical college 6 Anna arch road NSk Nagar Arumbakkam chennai 106 |
| 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 P Shobanashree |
Aringar Anna hospital of Indian medicine |
Room no 25 siddha department 6 Anna arch road NSK nagar arumbakkam chennai
Chennai
TAMIL NADU |
9942912256
dr.shobanashree301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government siddha medical college arumbakkam |
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 |
| Intervention |
KANNAIKU ATTHI NEI |
2 TO 5 ML given 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 |
age 3 to 12 years
cough without expulsion
wheezing
dyspnea
rhinitis |
|
| ExclusionCriteria |
| Details |
primary complex
hypersensitivity pneumonitis
lung abscess
cystic fibrosis
bronchiolitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical assesment of bronchial asthma is carried out on the basis of modified asthma scale, and comparing the clinical symptoms before and after treatment |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| it is assessed by comparing the safety parameters before and 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)
|
25/10/2020 |
| 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 an phase II open single non randomized study to evaluate the official Siddha formulaiton "Kannaiku atthi nei" internally for Bronchial asthma (sooli kanam) . The trial drug is given 2 to 5 ml twice a day for 21 days. clinical trial conducted after conducting pre-clinical toxicity study. The trial drug Kannaiku atthi nei is mentioned in kumbamuni balavagadam book. During the trial study related data will be recorded and documented. after the completion of the trial all the data will be analysed statistically. |