| CTRI Number |
CTRI/2023/10/058899 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Evaluation Of The Efficacy Of Pathoora Thylam (Nasiyam) For The Treatment Of Peenisam(Sinusitis) |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation Of The Efficacy Of Pathoora Thylam (Nasiyam) And Regular OPD Medicine For The Treatment Of Neer Peenisam (Sinusitis)-A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyadharshini S |
| Designation |
Medical officer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9788999836 |
| Fax |
|
| Email |
spriyadharshini1221@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr GJ Christian,MD,PhD |
| Designation |
Hospital Superintendent(i/c),Professor and Head Of The Department |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyadharshini S |
| Designation |
Medical officer |
| Affiliation |
National Institute of Siddha |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai
TAMIL NADU
600047
India |
| Phone |
9788999836 |
| Fax |
|
| Email |
spriyadharshini1221@gmail.com |
|
|
Source of Monetary or Material Support
|
| National iInstitute Of Siddha
Tambaram Sanatorium |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
-
|
| Type of Sponsor |
Other [] |
|
|
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 S Priyadharshini |
Ayothidoss Pandithar Hospital,National institute of siddha |
Out Patient Department,
Nationala Institute Of Siddha,
Tambaram Sanatorium
Chennai-600047
Chennai
TAMIL NADU |
9788999836
spriyadharshini1221@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,National Institute Of Siddhae |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J06||Acute upper respiratory infections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pathoora thylam |
3 drops should be administered through nostrils with the duration of once in a 4 days |
| Comparator Agent |
Regular OPD medicines
T.THIRIKADUGU CHOORANAM
T.MUTHUCHIPPI PARPAM
GOWRI CHINDAMANI CHENDHURAM |
T.THIRIKADUGU CHOORANAM -2 tds with hot water
T.MUTHUCHIPPI PARPAM -2 tds with hot water
GOWRI CHINDAMANI CHENDHURAM -200 mg with honey given at a duration of 14 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were willing to give informed consent.
Present with the symptoms of Headache,sneezing,Itching in nose and eyes,
nasal congestion,rhinorrhea,post nasal drip, Halitosis,Facial pain /pressure
Pain and tenderness over paranasal sinuses.
Patients who had radiological evidence of sinusitis. |
|
| ExclusionCriteria |
| Details |
Children age below 12 and above 60 years
Patient who were not willing to particiate in the study will be excluded from
the study
Patients with other serious illness who are on medical emergencies.
Patients with known history of tuberculosis,HIV were excluded from the study.
Hepatits B&C
Haemophilia & Bleeding Disorder
Uncontrolled Diabetes Mellitus |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in clinical symptoms of Neer peenisam by Adelaide Disease Severity Score . |
12 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of clinical lab parameters |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/10/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The Present study is single arm clinical trial to assess the efficacy of Pathoora thylam(Nasiyam) for the treatment of Neer Peenisam.In this trial 20 Patients will be recruited and the trial drug is administered externally through nostrils(3 drops) for once in 4 days.Primary Outcome will be assessed by the efficacy of Pathoora thylam for the reduction in clinical symptoms by Adelaide Disease Severity Score and the secondary outcome by observe changes in clinical lab parameters-TC,DC,ESR,AEC and IgE pre and post treatment.
|