| CTRI Number |
CTRI/2021/10/037531 [Registered on: 25/10/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of siddha trial drug kana mantha mathirai for kana mantham (Gastro Enteritis) |
|
Scientific Title of Study
|
Phase II Non Randomized Clinical Study On Kana Mantham (Gastro Enteritis)with the Evaluation of Siddha trial drug Kana Mantha Mathirai 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 v Gayathri |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai-106. |
| Address |
Post graduate Room no 25
Department of kuzhanthai maruthuvam
Government siddha medical college chennai 106 Tamilnadu
Post graduate Room no 25
Department of kuzhanthai maruthuvam
Government siddha medical college chennai 106 Tamilnadu
Chennai
TAMIL NADU
600106
India |
| Phone |
8012196708 |
| Fax |
|
| Email |
gayathri6vivek@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr v Rani |
| Designation |
HOD and Lecturer |
| Affiliation |
Governnment siddha medical college |
| Address |
Post graduate Head of the department
Department of Kuzhanthai Maruthuvam
Government siddha medical college Chennai
Post graduate Head of the department
Department of Kuzhanthai Maruthuvam
Government siddha medical college Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
6369113461 |
| Fax |
|
| Email |
drvranimd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr v Gayathri |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical college |
| Address |
Posr graduate room no 25
Department of Kuzhanthai Maruthuvam
Government siddha medical college
Posr graduate room no 25
Department of Kuzhanthai Maruthuvam
Government siddha medical college
Chennai
TAMIL NADU
600106
India |
| Phone |
8012196708 |
| Fax |
|
| Email |
gayathri6vivek@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college chennai |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
6 anna arch road NSK nagar Arumbakkam chennai 106 |
| Type of Sponsor |
Government medical college |
|
|
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 v Gayathri |
Government siddha medical college |
Department of Kuzhanthai maruthuvam NSK nagar Arumbakkam
Chennai
TAMIL NADU |
8012196708
gayathri6vivek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kana mantha mathirai |
0.7 mg of tablet bd for 21 days |
| Comparator Agent |
nil
|
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Diarrhea
fever
Bloating abdomen
Headache
watery nasal discharge
weight loss |
|
| ExclusionCriteria |
| Details |
Protein energy malnutrition
severe dehydration
Tuberculosis
Pneumonia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Vesikari score
Reduction in clinical symptoms
|
14 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing safety parameters before and after treatment |
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)
|
30/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/11/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single Non randomized Open Clinical Trial to study the safety and efficacy of siddha trial drug kana mantha mathirai is to be given 0.7 gm twice a day for 14 days. Clinical trial conducted after conducting pre clinical toxicity study. The trial drug kana mantha mathirai has mentioned in Aathma ratchamirdhamm enum vaidhiya saarangiragam. During the trial study related data will be recorded and documented.After the completion of trial all data will be stastistically analysed. |