| CTRI Number |
CTRI/2021/10/037652 [Registered on: 28/10/2021] Trial Registered Prospectively |
| Last Modified On: |
28/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of the drug Suringiyathi Chooranam for the management of patients with Sinusitis( Azhal thalainokkadu) |
|
Scientific Title of Study
|
Phase II Non-randomized open clinical evaluation of siddha medicine Suringiyathi Chooranam for the management of Azhal Thalainokkadu (Sinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jayasri J M |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai TamilNadu India
Government Siddha Medical College Arumbakkam Chennai 600106 TamilNadu India
Chennai
TAMIL NADU
600106
India |
| Phone |
9843294118 |
| Fax |
|
| Email |
jayasrivishva84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chithra U |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai TamilNadu India
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 TamilNadu India
Chennai
TAMIL NADU
600106
India |
| Phone |
9025006404 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chithra U |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai TamilNadu India
Post Graduate Department of General Medicine Government Siddha Medical College Arumbakkam Chennai 600106 TamilNadu India
Chennai
TAMIL NADU
600106
India |
| Phone |
9025006404 |
| Fax |
|
| Email |
mmsankar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Anna arch road Arumbakkam Chennai 600106 TamilNadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College Anna arch road Arumbakkam Chennai 600106 TamilNadu |
| 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 Jayasri J M |
Aringar Anna Government Hospital of Indian Medicine |
Room no 1 Siddha department of medicine 6 Anna arch road Arumbakkam Chennai 600106 TamilNadu
Chennai
TAMIL NADU |
9843294118
jayasrivishva84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Suringiyathi Chooranam |
2gms of Suringiyathi Chooranam idhu administered twice a day with hot water for 48 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Rhinorrhoea
Headache
Pain and tenderness over para nasal sinus
Recurrent sneezing
Hyposmia or anosmia
Nasal congestion |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
Vasomotor rhinitis
Opthalmic headache
Migraine
Otitis media |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by reduction of clinical symptoms after 48 days and also assessed by Adelaide symptoms severity score |
Primary outcome is mainly assessed by reduction of clinical symptoms after 48 days and also assessed by Adelaide symptoms severity score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is mainly assessed by comparing the safety parameters before and after treatment |
48days |
|
|
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)
|
30/10/2021 |
| 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
|
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 randomised open clinical trial to study the safety and efficacy of Suringiyathi Chooranam. The trial drug is given 2gms twice a day for 48days. The clinical trial is conducted after conducting pre clinical toxicity study. The trial drug Suringiyathi Chooranam is mentioned in Anuboga vaithiya Deva Ragasiyam.During the trial all the study related date will be recorded and documented. After the completion of trial all the data will be analysed statistically. |