| CTRI Number |
CTRI/2014/08/004828 [Registered on: 06/08/2014] Trial Registered Prospectively |
| Last Modified On: |
15/07/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical research of siddha medicine in the management of common cold (Neerkanamantham) |
|
Scientific Title of Study
|
A Clinical Evaluation of MATHULAI NEI for the treatment of NEERKANAMANTHAM 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 |
Valarmathi |
| 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 |
|
| Fax |
|
| Email |
valarchinnappan89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Valarmathi |
| 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 |
|
| Fax |
|
| Email |
valarchinnappan89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi Sundaram |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Kuzhandhai Maruthuvam
National Institute of Siddha,
Tambaram Sanatorium, Chennai-47
Dept of Kuzhandhai Maruthuvam National Institute of siddha Tambaram Sanatorium Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
|
| 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 |
| Dr CValarmathi |
National Institute of Siddha |
Department of Kuzhandhai Maruthuvam
National Institute of Siddha,
Tambaram Sanatorium, Chennai-47
Chennai
TAMIL NADU |
8056243683
valarchinnappan89@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 |
cough
Rhinorrhoea
fever
headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mathulai Nei for Neerkanamaantham in children |
Mathulai Nei is a polyherbal formulation- 16g- BD orally for 7 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptoms of cough
Patients with symptoms of Rhinorrhoea
Patients with fever
Patients with history of headache
Patients with history of abdominal pain
Patients with history of diarrhea
Patients with malaise/headache
Willing to give specimen of blood for investigation when required.
Willing to be admitted in the hospital or willing to attend OPD once in 7 days.
|
|
| ExclusionCriteria |
| Details |
Children below 7 yrs age
Continous fever for few days
Signs of dehydration
Breathing problems
Patient’s with any other serious illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Good – Relieved of all clinical symptoms
Moderate – Reduction of some clinical symptoms
Poor – No improvement or change in the clinical symptoms
|
7-10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of symptoms |
before and after treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/09/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
After completion of the 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 Mathulai Nei (Intenal Medicine) a herbal drug (Containing Pomogranate, cardamon, Myristica fragrans,butter) administered orally twice a day. The drug dosage is 5.3ml 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.
|