CTRI Number |
CTRI/2014/08/004825 [Registered on: 05/08/2014] Trial Registered Retrospectively |
Last Modified On: |
14/08/2014 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Siddha |
Study Design |
Single Arm Study |
Public Title of Study
|
A Clinical Management of Bronchial asthama |
Scientific Title of Study
|
Clinical Evaluation of Kodagasalai Ennai in the treatment of Suzhimantham in children |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
KElavarasan |
Designation |
PG Scholar |
Affiliation |
National Institute of Siddha |
Address |
Department of Kuzhandhai Maruthuvam
National Institute of Siddha
Tambaram Sanatorium, Chennai-47
Chennai TAMIL NADU 600047 India |
Phone |
9952144747 |
Fax |
|
Email |
drelavarasanmd@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
KElavarasan |
Designation |
PG Scholar |
Affiliation |
National Institute of Siddha |
Address |
Department of Kuzhandhai Maruthuvam
National Institute of Siddha
Tambaram Sanatorium, Chennai-47
TAMIL NADU 600047 India |
Phone |
9952144747 |
Fax |
|
Email |
drelavarasanmd@gmail.com |
|
Details of Contact Person Public Query
|
Name |
MMeenakshi Sundaram |
Designation |
Associate Professor |
Affiliation |
National Institute of Siddha |
Address |
Department of Kuzhandhai Maruthuvam
National Institute of Siddha
Tambaram Sanatorium, Chennai-47
Chennai TAMIL NADU 600047 India |
Phone |
9444214582 |
Fax |
|
Email |
mmssiddha@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
National Institute of Siddha |
Address |
Department of Kuzhandhai Maruthuvam
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 |
DrKElavarasan |
National Institute of Siddha |
Department of Kuzhandhai Maruthuvam
National Institute of Siddha
Tambaram Sanatorium, Chennai-47
Chennai TAMIL NADU |
9952144747
drelavarasanmd@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 |
Intermittent fever, wheezing, lack of appetite, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
KODAGASALAI ENNAI Internal drug for Suzhimaantham |
KODAGASALAI ENNAI is a poly herbal drug- 160 mg- OD dose for 7 days.
|
Comparator Agent |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
1.00 Year(s) |
Age To |
3.00 Year(s) |
Gender |
Both |
Details |
Intermittent fever
Wheezing
Insomnia
Hiccough
Lack of appetite
Dyspnoea
Indrawing of respiratory muscles |
|
ExclusionCriteria |
Details |
Jaundice
Enteric fever
Pneumonia
Congenital heart disease
Any other serious illness |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Results and observation during the study inclusive of clinical improvements |
2-3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Results and observation during the study inclusive of clinical improvements |
Before treatment and after treatment |
|
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)
|
09/06/2014 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
After completion of study |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This is a single arm open clinical trial to find out the thereapeutic effect of Kodagasaalai Ennai (Intenal Medicine) a herbal drug Containing Justica adhathoda, Allium sativum, Occimum sanctum, Lecus caspera, Tinospora cordifolia, Myrstica fragrans, Asafoeitida, Castor oil, Ox gall, Picorrhiza kurroa, Azima tetracantha, Cuscuta reflex administered orally once a day. The drug dosage is 160 mg for seven days. The clinical assessment and laboratory investigations will be recorded in case report form(CRF) for all patients.After completion of the trial all the data will be analysed statisticaly and the research reports will be published in Indian journal of medical research.
|