| CTRI Number |
CTRI/2018/08/015380 [Registered on: 20/08/2018] Trial Registered Prospectively |
| Last Modified On: |
26/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on siddha trial drug manjanaathi kudineer chooranam in children having acute nasopharyngitis |
|
Scientific Title of Study
|
An open clinical study on neerkana mantham(acute nasopharynngitis) in children with the evaluation of siddha trial drug manjanaathi kudineer chooranam |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Haripriya |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate department of Kuzhanthai Maruthuvam Government siddha medical college
No 6 Anna arch road
Arumbakkam
Chennai
Government siddha medical college
Arumbakkam
Chennai
Chennai
TAMIL NADU
106
India |
| Phone |
8220321809 |
| Fax |
|
| Email |
piriyaa16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakumari |
| Designation |
Professor |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate department of Kuzhanthai Maruthuvam Government siddha medical college
No 6 Anna arch road
Arumbakkam
Chennai
Government siddha medical college
Arumbakkam
Chennai
Chennai
TAMIL NADU
106
India |
| Phone |
9176534465 |
| Fax |
|
| Email |
dr.meenakumari.km@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakumari |
| Designation |
Professor |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate department of Kuzhanthai Maruthuvam Government siddha medical college
No 6 Anna arch road
Arumbakkam
Chennai
Government siddha medical college
Arumbakkam
Chennai
Chennai
TAMIL NADU
106
India |
| Phone |
9176534465 |
| Fax |
|
| Email |
dr.meenakumari.km@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arignar Anna Government Siddha Medical College no6 Anna arch road, nsk road, arumbakkam, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
No 6 Anna arch road
Arumbakkam
Chennai |
| 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 |
| M HARIPRIYA |
Arignar anna hospital for Indian Medicine |
Room no 21
Department of kuzhanrhai maruthuvam
Arignar anna hospital
No 6 Anna arch road
Nsk nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU |
8220321809
piriyaa16@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], (2) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manjanaathi kudineer chooranam |
8grams of manjanaathi kudineer chooranam twice a day for 7days as internal medicine |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Running nose, Cough, Fever, Malaise |
|
| ExclusionCriteria |
| Details |
Allergic rhinitis, Bronchitis, Bronchial asthma, Rheumatic fever, Tonsilitis |
|
|
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 comparing the reduction in clinical symptoms (like running nose, fever, cough, malaise) and recurrence in before and after treatment |
Nil |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
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)
|
24/08/2018 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open clinical study to evaluate the efficacy of manjanaathi kudineer chooranam of 8gram will be given for 7 days which contains some active herbs having anti microbial properties which will be helpful in curing neerkana maantham (acute nasopharyngitis) |