| CTRI Number |
CTRI/2017/02/007952 [Registered on: 22/02/2017] Trial Registered Prospectively |
| Last Modified On: |
01/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Medical Device
Siddha
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical trail of kana kazhichal |
|
Scientific Title of Study
|
A Clinical Evaluation of Mookurattai Ennai a siddha drug for Bacillary Dysentery in children on open clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARUNASALAM S |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Siddha |
| Address |
Ayothidoss Pandithar Hospital Department of Kuzhanthai
maruthuvam National Institute of siddha Tambaram Sanatorium Chennai
National institute of Siddha Ayothidoss Pandithar Hospital Tambarm Sanatorium Chennai 600047
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9543739979 |
| Fax |
04422381314 |
| Email |
smaruna8775@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Meenakshi sundaram |
| Designation |
Associate Professor HOD incharge |
| Affiliation |
National Institute of Siddha |
| Address |
National institute of siddha Ayothidoss Pandithar Hospital Tambaram Sanatorium Chennai
National Institute of Siddha Ayothidoss Pandithar hospital Tambarm Sanatorium Chennai
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
04422381314 |
| Email |
mmssiddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Suresh |
| Designation |
Lecturer |
| Affiliation |
National Institute of Siddha |
| Address |
National institute of Siddha Ayothidoss Pandithar Hospital Tambaram Sanatorium Chennai-47
National Institute of Siddha Ayothidoss Pandithar Hospital Tambaram Sanatorium Chennai-47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
04422381314 |
| Email |
drsureshherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Department of Kuzhandhai maruthuvam OP NO 9National institute of Siddha Ayothidoss Pandithar Hospital 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 |
| S Arunasalam |
NATIONAL INSTITUTE OF SIDDHA |
Ayothidoss Pandithar Hospital Department of Kuzhandhai
maruthuvam National institute of Siddha Tambaram Sanatorium Chennai-47 Tamil nadu
Kancheepuram
TAMIL NADU |
9543739979
04422381314
smaruna8775@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 |
patients with symptoms of increased frequency of stool with mucus atleast 3-4 times per day fever abdominal pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MOOKURATTAI ENNAI internal medicine |
MOOKURATTAI ENNAI internal medicine 1.6 ml per oral od for 3 days |
| Comparator Agent |
Na |
Na |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Frequent passing of stools with mucus at least 3 or 4 times per day
Fever
Abdominal pain
|
|
| ExclusionCriteria |
| Details |
High fever
Severe dehydration
Extra intestinal complication
Chronic diarrhoea |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Good-reduced all clinical symptoms
Moderate-reduced some clinical symptoms
Poor-No improvement or change in clinical
symptoms |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is mainly assessed by therapeutic efficacy of
the trial drugs
|
1 month |
|
|
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)
|
25/02/2017 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the therapeutic efficacy of siddha polyherbal formulation mookurattai ennai in the treatment of kana kazhichal bacillary dysentry in children I belive it work well
|