| CTRI Number |
CTRI/2016/04/006787 [Registered on: 01/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
30/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial for bacillary dysentry in children |
|
Scientific Title of Study
|
Clinical evaluation of Adhimadhura Mathirai a siddha drug for kanakazhichal 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 |
D SARANYA |
| Designation |
PG SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Chennai
TAMIL NADU
600047
India |
| Phone |
9597907472 |
| Fax |
|
| Email |
sarosaranya13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Kalyana Sundaram |
| Designation |
Head of the Department Kuzhandhai Maruthuvam |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Chennai
TAMIL NADU
600047
India |
| Phone |
9444946270 |
| Fax |
|
| Email |
kalyas53@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKSuresh |
| Designation |
Lecturer of Kuzhadhai Maruthuvam |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI
Chennai
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@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 |
| 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 D Saranya |
NATIONAL INSTITUTE OF SIDDHA |
DEPARTMENT OF KUZHANDHAI MARUTHUVAM NATIONAL INSTITUTE OF SIDDHA TAMBARAM SANATORIUM CHENNAI 600047
Chennai
TAMIL NADU |
9597907472
sarosaranya13@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 |
•Increase in frequency of mucous in stools
•Rumblings in the intestine.
•mild fever and Abdominal cramps
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adhimathura Maathirai |
thoodulangai alavu(580 mg) b.d. orally 5-12 years (3 days) |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Increased frequency of mucous in stools
Rumblings in the intestine.
mild fever and chills
history of abdominal pain
|
|
| ExclusionCriteria |
| Details |
Continous fever for few days
Signs of profuse dehydration.
Extra intestinal complication.
Exacerbation of chronic diarrhea in inflammatory bowel disease or malabsorption.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical symptoms releived |
Clinical symptoms releived |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical efficacy of the trial drug |
nil |
|
|
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)
|
18/06/2015 |
| 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)
|
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 poly herbal formulation adhimadhura mathirai in the treatment of kana kazhichal... |