| CTRI Number |
CTRI/2018/03/012379 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2018 |
| 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 SANGU CHUNNAM in patients having Azhal thalai Nokkadu (Sinusitis) |
|
Scientific Title of Study
|
An open Non-Randomized clinical trial of Sangu Chunnam in Azhal Thalai Nokkadu (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 Indumathy V |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9566536378 |
| Fax |
|
| Email |
illavarasi.indu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indumathy V |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Post Graduate Department of General Medicine
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
8838371032 |
| Fax |
|
| Email |
illavarasi.indu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
600106
TamilNadu |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College
6 Anna arch road
NSK Nagar
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 Indumathy V |
Aringar Anna Government Hospital of Indian Medicine |
Room No 2
Siddha Department
Aringar Anna hospital
6 Anna arch road
NSK nagar
Arumbakkam
Chennai
600106
Chennai
TAMIL NADU |
9566536378
illavarasi.indu@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 |
AZHAL THALAI NOOKADU (SINUSITIS), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SANGU CHUNNAM |
130 mg of Sangu chunnam is administrated twice a day with honey for 48 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age between 16 to 60 years
Both male and female
Nasal congestion
Running Nose
Headache
Heaviness of Head
Pain and Tenderness over at PNS area
Recurrent Sneezing
Patients with positive x-ray findings |
|
| ExclusionCriteria |
| Details |
Age factor - below 16 and above 60 years
Pregnancy
Lactation
Diabetes Mellitus
Vasomotor Rhinitis
Migraine
Otitis Media
Malignancy of PNS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is estimated by scoring the clinical symptoms and investigations before and after treatment |
48 days |
|
|
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)
|
05/01/2018 |
| 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) |
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 Sangu Chunnam. The trial drug is given 130 mgs twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Sangu Chunnam is mentioned in Anuboga Vaidhiya Navaneetham - part I. 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. |