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A study of Seenthil chooranam (internal) and Vetiver Thailam (external) in the management of Neer Peenisam (sinusitis)

Phase 3
Completed
Conditions
Acute sinusitis, unspecified,
Registration Number
CTRI/2023/09/058006
Lead Sponsor
National Institute of Siddha
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria
  • 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.
Exclusion Criteria
  • • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The outcome will be mainly assessed by reduction in clinical symptoms after the18 months
treatment by using Adelaide Disease severity score below 1218 months
Secondary Outcome Measures
NameTimeMethod
To observe changes in clinical lab parameters–TC, DC, ESR, AEC & IgE pre and post treatment18 months

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital

🇮🇳

Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Dr T Jelsha Forshia
Principal investigator
9944597957
forshiatensingh@gmail.com

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