| CTRI Number |
CTRI/2015/01/005381 [Registered on: 09/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study in the management of indigestion in children using Siddha medicine |
|
Scientific Title of Study
|
A Clinical management of Kattu mantham noi in chiildren with trial drug Mukkadukadhi mathirai - An open trial 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 |
DrSSudhasini |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of siddha |
| Address |
Dept of Kuzhandhai Maruthuvam National Institute of siddha Tambaram
Sanatorium Chennai
National Institute of siddha Tambaram
Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9094481496 |
| Fax |
04422381314 |
| Email |
drsudhasettu@gmal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSSudhasini |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of siddha |
| Address |
Dept of Kuzhandhai Maruthuvam National Institute of siddha Tambaram
Sanatorium Chennai
National Institute of siddha Tambaram
Sanatorium Chennai
TAMIL NADU
600047
India |
| Phone |
9094481496 |
| Fax |
04422381314 |
| Email |
drsudhasettu@gmal.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMMeenakshi Sundaram |
| Designation |
Associate Proffesor |
| Affiliation |
National Institute of siddha |
| Address |
Dept of Kuzhandhai Maruthuvam National Institute of siddha Tambaram
Sanatorium Chennai
National Institute of siddha Tambaram
Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9094481496 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of siddha |
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
National Institute of Siddha Tambaram Sanatirium chennai |
| 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 |
| Sudhasini |
National Institute of siddha |
Department of Kuzhandhai maruthuvam
National Institute of siddha
Tambaram sanatorium
chennai-47
Chennai
TAMIL NADU |
9094481496
drsudhasettu@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 |
Kattu mantham - Indigestion, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mukkadukadhi mathirai |
Mukkadukadhi mathirai is a polyherbal formulation Sundaikkai alavu: (800mg)b.i.d oral routefor 3 days |
| Comparator Agent |
Not apllicable |
Not apllicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Age 1 to 3 years
Indigestion
Stomach pain
Cough
Fever
Yawning
Prespiration
|
|
| ExclusionCriteria |
| Details |
Renal Failure
Typhoid ,Malaria
Irritable Bowel Syndrome
Congenital Heart Diseases
Childhood Asthma
Patient not willing to give blood sample
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Constipation relieved |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All other clinical symptoms relieved. |
2-3 weeks |
|
|
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)
|
29/06/2014 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an Open clinical trial, to evaluate the therapeutic efficacy of Mukkadukadhi mathirai (internal medicine) from the siddha texts. It is a herbal drug constituting Zingiber officinale, Piper nigrum, Piper logum, Acorus calamus, Nigella sativa, Terminalia chebula, Phlyla nodiflora. The medicine will be given at a dosage of 800 mg tablet orally for 3 days. All the recorded data will be recorded in Case Report Form (CRF) for each patients seperately.
|