| CTRI Number |
CTRI/2025/04/085801 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the therapeutic effectiveness of nasiyam using Aathondai nasiya thylam in the management of Peenisam (Sinusitis) |
|
Scientific Title of Study
|
An open labelled non randomized phase II clinical trial to evaluate the therapeutic effectiveness of nasiyam(An external therapy)using -Aathondai nasiya thylam in the management of Peenisam |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRMEENA |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and hospital |
| Address |
Second year,
Department of Pura Maruthuvam,
Government Siddha Medical College and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8903784108 |
| Fax |
|
| Email |
dr.meenarajamani98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGGANESAN MDs |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pura Maruthuvam, Government Siddha Medical College and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9842474166 |
| Fax |
|
| Email |
ganesangabriel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSSUJATHA MDs |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pura Maruthuvam, Government Siddha Medical College and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442331462 |
| Fax |
|
| Email |
sujatharajasekar66@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central library of Government Siddha Medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Dr R MEENA |
| Address |
II year PG Scholar Department of Pura Maruthuvam, Government Siddha Medical College and hospital, Palayamkottai, Tirunelveli -627002 |
| 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 |
| Dr R MEENA |
Government Siddha Medical College and hospital |
II year PG Scholar
Department of Pura Maruthuvam Government Siddha Medical College and hospital
Tirunelveli
TAMIL NADU |
8903784108
dr.meenarajamani98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical college and hospital,palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aathondai nasiya thylam |
Nasal drops for 21 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from symptoms like nasal congestion, continuous sneezing ,headache or heaviness of head,pain in the face and ear,nasal or postnasal discharge, hyposmia
Patients who are willing to give radiological investigation and provide blood for lab investigation
Patients who are willing to sign the informed consent stating that he/she will stick to the treatment during the study period but can option out of the trail on his/her own conscious discretion |
|
| ExclusionCriteria |
| Details |
Age below 15 years and above 70 years
Patients suffering from epistaxis, lower respiratory tract infections, CAD, Tuberculosis,HIV,Cancer
pregnant and lactating women, Epilepsy,CSF Rhinorrhoea, Haemophilia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients symptoms will be reduced along with their improvement in their quality of life |
21 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)
|
10/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open labelled non-randomized phase II clinical trial to evaluate the therapeutic effectiveness of NASIYAM an external therapy using AATHONDAI NASIYA THYLAM in the management of PEENISAM.The trial drug will be an nasal application for daily for 21days in 40 patients.The trial period of 24 months will be carried out in Government siddha medical College and hospital, Palayamkottai, Tirunelveli 627002, Tamilnadu.The outcome will be an external therapy Nasiyam towards the management of Peenisam, expect the patients to be relieved from the symptom.In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilence department for further management .The patients will be managed as OPD patients. |