| CTRI Number |
CTRI/2018/04/013286 [Registered on: 16/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study on siddha trail drug Muruvili Kudineer(int) in patients having Singimantha kanam |
|
Scientific Title of Study
|
An open Non-Randomized clinical trial to Evaluate the efficacy of Muruvili kudineer in Singimantha Kanam(Bronchitis) Among children between 3 to 13 years. |
| Trial Acronym |
Mv Kudineer |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abisha A |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department Of Kuzhanthai Maruthuvam
Government Siddha Medical College 6 Anna Arch Road NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8056202613 |
| Fax |
|
| Email |
abishabsms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Shanmugapriya |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department Of Kuzhanthai Maruthuvam
Government Siddha Medical College No 6 Anna Arch Road NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abisha A |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department Of Kuzhanthai Maruthuvam
Government Siddha Medical College 6 Anna Arch Road NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8056202613 |
| Fax |
|
| Email |
abishabsms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 |
| 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 Abisha A |
Aringar Anna Government hospital of Indian Medicine |
Room 20 Siddha Department Aringer Anna Hospital 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106
Chennai
TAMIL NADU |
8056202613
abishabsms@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 |
Singimantha kanam(Bronchitis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muruvili Kudineer |
15 to 30 ml Twice a Day administered orally for 7 Days |
| Comparator Agent |
NIl |
NIl |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Age 3-13years
Sex:Both Male and Female children
Fever
Dynpnea
Dry or Productive cough
Wheezing
Patients who are all willing to give blood samples at subsequent visit are involved in this study |
|
| ExclusionCriteria |
| Details |
Allergic rhinitis
Asthma
Refluxoesophagitis
Upper respiratory infections/common cold
Bronchiolitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by BS Score reduction in clinical symptoms like fever, cough, sputum, dyspnea, wheezing before and after treatment |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
7 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)
|
10/07/2017 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Single Non randomized open clinical trial to study the safety and efficacy of Siddha trial drug Muruvili Kudineer. The trial drug is given 15 - 30 ml twice a day for 2 consecutive cycles.Clinical trial is conducted after conducting pre clinical toxicity study. During the trial all the study related data will be recorded and documented.After the completion of trial all the data will be analysed statistically. |