| CTRI Number |
CTRI/2024/05/067699 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Peenisa chooranam for mookadaippu |
|
Scientific Title of Study
|
Single centric non Randomized open clinical Trial Phase II In Azhal thalainokkadu Sinusitis with Siddha Medicine Peenisa Chooranam among patients attending opd at Government Siddha medical college Hospital Chennai |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Sujatha |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Post Graduate Department of Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
7550168344 |
| Fax |
|
| Email |
sujatha.srinivasan22384@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Ujjeevanam |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9884175653 |
| Fax |
|
| Email |
ujjeevanam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Ujjeevanam |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College Chennai |
| Address |
Department of Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9884175653 |
| Fax |
|
| Email |
ujjeevanam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Siddha Medical College Arumbakkam Chennai -600106 Tamilnadu ,India |
|
|
Primary Sponsor
|
| Name |
R Sujatha |
| Address |
Post Graduate Department of Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai 600106 Tamil nadu India |
| 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 Sujatha |
Government Siddha Medical College |
Room No S1 Department of PG Pothu Maruthuvam Arumbakkam Chennai
Chennai
TAMIL NADU |
7550168344
sujatha.srinivasan22384@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, government siddha medical College, chennai |
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 |
Peenisa Chooranam |
This Siddha Drug will be given as 1.5 gm bd dose with luke warm water for 28 Days for the management of Sinusitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 All gender
2 Rhinorrhea
3 Nasal congestion
4 Pain and tenderness over paranasal sinus
5 Headache |
|
| ExclusionCriteria |
| Details |
1 Septal deviation
2 Fungal sinusitis
3 Opthalmic headache
4 Trigeminal neuralgia
5 Sinus polyposis
6 Migraine
7 Otitis media
8 Vasomotor rhinitis
9 Pregnant and Lactating mother |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome of the treatment will be mainly assessed by reduction in clinical symptoms such as nasal obstruction,rhinitis,Post nasal drip,head ache ,facial pain. |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in clinical symptoms like nasal obstruction rhinorrhea post nasal drip headache |
28 days |
|
|
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)
|
09/09/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 02-06-2025 and end date provided 31-12-2026?
Response (Others) - Nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Sinuses are four paired cavities inside the head. narrow passages connect them. sinuses make mucus that drains out of the passages through nose. this drainage helps keep the nose clean and free of bacteria, allergens and other germs. sinusitis is an inflammation, or swelling, of the tissue lining of sinuses. Sinuses are structures inside the face that are normally filled with air. bacterial infections, viral infections and allergies can irritate them. causing them to get blocked and filled with fluid. it can cause pressure and pain in the face, nasal congestion and other symptoms. symptoms include nasal inflammation, thick discolored discharge from the nose, drainage down the back of the throat, nasal obstruction or congestion, pain, tenderness and swelling around the eyes, cheeks, nose or forehead, reduced sense of smell and taste, ear pain aching in upper jaw and teeth and cough. Types of sinusitis can be defined based on how long it’s been going on and what’s causing it. acute sinusitis symptoms last less than four weeks. Subacute sinusitis symptoms last from to 12 weeks. chronic sinusitis symptoms last at least for 12 weeks. recurrent acute sinusitis symptoms come back four or more times in one year last less than two weeks each time. In Siddha system of medicine, there are many unique combinations of medicines which have solution to the scenario of "AZHAL THALAINOKKADU"(SINUSITIS). one such combination is PEENISA CHOORANAM which will be cost effective and reliable. so, it is considered to evaluate the siddha herbal formulation PEENISA CHOORANAM mentioned in DHANVANDHRI SOOTCHAMA VAITHIYAM 200 VISHA BEDHI VAITHIYAM page no 36 for the treatment of " AZHAL THALAINOKKADU"(SINUSITIS). the therapeutic efficacy of this Siddha formulation is so for not evaluated clinically for this disease.so the author tries to evaluate its efficacy in an open clinical trial.
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