| CTRI Number |
CTRI/2019/07/020150 [Registered on: 11/07/2019] Trial Registered Prospectively |
| Last Modified On: |
21/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect on oral administration of a classical siddha drug catakuppai cūraṇam along with external administration of pīṉica tailam in management of headache and running nose |
|
Scientific Title of Study
|
Clinical evaluation of the effect on oral administration of catakuppai cūraṇam along with external administration of pīṉica tailam in management of nīrpīṉicam |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uma Shankari S |
| Designation |
Post Graduate Student |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7339230907 |
| Fax |
|
| Email |
saus1494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shyamala K |
| Designation |
Lecturer Grade- II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyamala K |
| Designation |
Lecturer Grade- II |
| Affiliation |
Government Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
palayamkottai,
Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002. |
|
|
Primary Sponsor
|
| Name |
Uma Shankari S |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Uma Shankari S |
Government Siddha Medical College and Hospital, Palayamkottai |
Department of kuzhanthai Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli- 627002.
Tirunelveli
TAMIL NADU |
7339230907
saus1494@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College, Palyamkottai, Tirunelveli-627002, Tamil Nadu, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J01||Acute sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Catakuppai cūraṇam |
Should be administered orally two times a day after food along with honey for a period of 14 days
dose: 1-2 ciá¹á¹ikai (30-60mg) |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Pīṉica tailam |
Should be applied on the scalp 30 minutes before morning bath
Duration: twice a week for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with any of the following symptoms will be included in the study
1. Nasal congestion
2. Purulent and watery nasal discharge
3. Pain and tenderness around the nose, orbit and maxillary region
4. Cough and sneezing
Subject should be ready to comply with the treatment protocols. |
|
| ExclusionCriteria |
| Details |
Subjects with
1. Severe and recurrent epistaxis due to sinusitis
2. Rhinitis due to tuberculosis
3. Any congenital anomalies
4. Rhinosporidiasis
will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reducing nasal congestion, Purulent and watery nasal discharge, Pain and tenderness around the nose, orbit and maxillary region, Cough and sneezing
|
Day 1 & Week 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessed by SNOT-22 |
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a single arm trial to determine the efficacy of catakuppai cūraṇam (Internal) and pīṉica tailam (External) in patients with nīrpīṉicam .The outcome will measured by day 1 ,week 1 and week 2 intervals.During this trial period if an adverse effects and serious adverse effects will be noticed and referred to Pharmocovigilance Department in Government Siddha Medical College and Hospital-Palayamkottai and further management will also be given in Department of Kuzhanthai Maruthuvam OPD and IPD .After completion of the trial all the study related data will be analyzed statistically. |