| CTRI Number |
CTRI/2018/05/014200 [Registered on: 29/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
18/05/2018 |
| 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 clinical trial to study the efficacy of Shayathirku Ennai in Sura peenisam(Sinusitis) |
|
Scientific Title of Study
|
An Open Non-Randomized Clinical Trial to Evaluate the Efficacy of Shayathirku Ennai in Sura Peenisam (Sinusitis)Among children between 8-12 years |
| Trial Acronym |
St Ennai |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dheebiga SV |
| Designation |
PG Scholar |
| Affiliation |
Govt siddha medical college |
| Address |
Post graduate department of kuzhanthai maruthuvam Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Government siddha medical college 6 Anna arch road NSK Nagar Arumbakkam Chennai 600 106
Chennai
TAMIL NADU
600106
India |
| Phone |
8220507093 |
| Fax |
|
| Email |
dr.dheebiga.sv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gandhimathi S |
| Designation |
Lecturer |
| Affiliation |
Govt siddha medical college |
| Address |
Post graduate department of kuzhanthai maruthuvam Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Government siddha medical college 6 Anna arch road NSK Nagar Arumbakkam Chennai 600 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9840788777 |
| Fax |
|
| Email |
Sgmathi16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheebiga SV |
| Designation |
PG Scholar |
| Affiliation |
Govt siddha medical college |
| Address |
Post graduate department of kuzhanthai maruthuvam Government Siddha Medical College 6 Anna Arch Road NSK Nagar Arumbakkam Chennai
Government siddha medical college 6 Anna arch road NSK Nagar Arumbakkam Chennai 600 106
Chennai
TAMIL NADU
600106
India |
| Phone |
8220507093 |
| Fax |
|
| Email |
dr.dheebiga.sv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical college 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 Dheebiga SV |
Aringar Anna Government Hospital of indian medicine |
Room No 20 Siddha Department Aringar Anna Hospital 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106
Chennai
TAMIL NADU |
8220507093
dr.dheebiga.sv@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 |
Sura Peenisam(Sinusitis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Shayathirku Ennai |
5ml twice a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age between 8-12 years
Pain and tenderness around nose,orbit,maxillary region
Nasal discharge
Nasal congestion
Conjuctival irritation
Hitory of recurrence upper respiratory infection
patients who are willing to sign to consent form
Patients who are willing to give blood sambles at subsequent visits are involved in this studies |
|
| ExclusionCriteria |
| Details |
infectious mononucleosis
Septal deviation
Chicken pox
Acute suppurative otitis media |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| outcome is mainly assessed by S1 self development score comparing the reduction in clinical symptoms and recurrence before and after treatment |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is assessed by the comparing the safety parameters of 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)
|
16/06/2017 |
| 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 open non randomized clinical trial to study the safety and efficacy of siddha trial drug Shayathirku Ennai.The trial drug is given 5ml twice a day for 7 days. Clical trial is conducted after counducting preclinical toxicity study. The trial drug Shayathirku Ennai is Mentioned in Agathiyar vaithiya vallathi 600. 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. |