| CTRI Number |
CTRI/2016/04/006818 [Registered on: 12/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
13/06/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trail for dyspepsia in children |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF SEENTHIL KUDINEER FOR KATTU MANTHAM (DYSPEPSIA) 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 |
Dr PMirunaleni |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai-47
National Institute of Siddha
Tambaram sanatorium
Chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
8122978302 |
| Fax |
|
| Email |
mirunalenibsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PMirunaleni |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai-47
National Institute of Siddha
Tambaram sanatorium
Chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
8122978302 |
| Fax |
|
| Email |
mirunalenibsms@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrAAmalaHazel MDs |
| Designation |
Lecturer |
| Affiliation |
|
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai-47
Chennai
TAMIL NADU
600047
India |
| Phone |
9486909809 |
| Fax |
|
| Email |
dramalaaruldhas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
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 P Mirunaleni |
Ayothidass pandithar hospital |
Room No -9 ,
Kuzhandhai maruthuvam Department ,Ayothidass pandithar hospital
National Institute of Siddha
Tambaram sanatorium
Chennai
Chennai
TAMIL NADU |
8122978302
mirunalenibsms@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 |
Constipation
Indigestion
Stomach Pain
Cough
Fever
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Seenthil Kudineer |
Seenthil kudineer 10 ml BD orally for a day only
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Indigestion
Stomach Pain
Cough
Fever
Constipation |
|
| ExclusionCriteria |
| Details |
Irritable Bowel syndrome
Childhood asthma
Intolerable stomach pain |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from the symptoms |
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any toxicity of the drug |
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)
|
15/09/2015 |
| 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 the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
My trial drug contains Tinospora cardifolia (seenthil thandu), Araca catechu (kali pakku), Operculina terpethum (sivathai), Terminalia chebula (kadukkai), Zingiber officinalis (sukku), Picrorhiza scrophulariiflora (kadukurokini), Aloe barbadence (katralai sarugu). it is given to children below 3 years orally twice a day in decotion form for a day to releive constipation. |