| CTRI Number |
CTRI/2023/09/058006 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A study of Seenthil chooranam
(internal) and Vetiver Thailam (external) in the management of Neer Peenisam (sinusitis) |
|
Scientific Title of Study
|
Clinical evaluation of siddha formulation Seenthil chooranam (internal) and Vetitver thailam (external) in the management of Neer Peenisam (sinusitis) among out-patients attending Ayothidoss Pandithar hospital, National Institute of Siddha |
| Trial Acronym |
SCVTNP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr T Jelsha Forshia |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9944597957 |
| Fax |
|
| Email |
forshiatensingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
drhnalinisofia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Nalini Sofia |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 7/8
Department of Maruthuvam
National Institute of Siddha
Tambaram Sanatorium Kancheepuram
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8939899363 |
| Fax |
|
| Email |
drhnalinisofia@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
Room No 7/8
Department of Maruthuvam National Institute of Siddha
Tambaram Sanatorium Kancheepuram Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 T Jelsha Forshia |
Ayothidoss Pandithar Hospital |
Room no 7/8
Department of Maruthuvam
Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
Kancheepuram
Kancheepuram
TAMIL NADU |
9944597957
forshiatensingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Sidddha |
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 |
Seenthil chooranam (internal) vetiver thailam (external) |
1.5g with honey twice daily after food.
DURATION: 48 days
vetiver thailam (external-oil bath) |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Headache / sneezing/nasal congestion/ rhinorrhea/ postnasaldrip/ facial
pain/ anosmia.
2.Pain and tenderness over paranasal sinuses.
3.Patient who has Adelaide Disease Severity Score above 12.
4.Patients who are willing to give informed consent.
5.Adults who are already diagnosed with sinusitis are included. |
|
| ExclusionCriteria |
| Details |
• K/C/O Migraine.
• Patients who have tumours in PNS X-ray
• Pregnancy and lactating mother.
• Patients with uncontrolled Diabetes.
• Patients who are not willing to participate in the study 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 |
The outcome will be mainly assessed by reduction in clinical symptoms after the
treatment by using Adelaide Disease severity score below 12 |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe changes in clinical lab parameters–TC, DC, ESR, AEC & IgE pre and post treatment |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| Date of Study Completion (India) |
08/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
INTRODUCTION: This is a clinical trial that evaluates the effectiveness of siddha formulation Seenthil chooranam ( internal) and Vetiver thailam (external) in the management of Neer peenisam (Sinusitis) in patients through Adelaide Disease Severity Score and clinical lab parameters–TC,DC, ESR, AEC and IgE pre and post treatment. Sinusitis is the inflammation of the sinuses, which are air filled cavities in the skull. The types of sinuses are maxillary, frontal, ethmoid and sphenoid. Among these maxillary and ethmoid sinuses quite often gets infected. The most frequently involved one is maxillary sinus. The overall prevalence of sinusitis was found to be 1.11%. The mean age of patients was 34 years and 70% of patients were suffering from chronic maxillary sinusitis. There is 20% of patients have positive family history of sinusitis.
PRIMARY OBJECTIVE: To evaluate the clinical effectiveness of siddha formulations Seenthil chooranam (internal) and vetiver thailam (external) in the management of neer peenisam (sinusitis) by using Adelaide Disease Severity Score.
SECONDARY OBJECTIVE: To observe changes in clinical lab parameters–TC,DC, ESR, AEC and IgE pre and post treatment.
MATERIALS AND METHODS: A total of 30 diagnosed adult patients of Neer peenisam willing to participate in the study , by signing the consent form will be enrolled in the study . Having Headache / sneezing/nasal congestion/ rhinorrhea/ postnasaldrip/ facial pain/ anosmia, Pain and tenderness over paranasal sinuses, Patient who has Adelaide Disease Severity Score above 12 will be included in this study and who are known case of migrane,tumours in PNS X-ray, Pregnancy and lactating mother, Patients with uncontrolled Diabetes mellitus are excluded. Assesssment will be done through Adelaide Disease Severity Score and clinical lab parameters–TC,DC, ESR, AEC and IgE pre and post treatment.
RESULTS AND DISCUSSION: The results will be statistically analysed.
KEYWORDS: Neer peenisam, Sinusitis, Seenthil chooranam , vetiver thailam |