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Clinical Trials/CTRI/2025/06/088773
CTRI/2025/06/088773
Not yet recruiting
Not Applicable

Effectiveness Of Shirovirechana Gana Taila Nasya and Mundopakulyadi Kashaya Pana In The Management Of Chronic Rhino-Sinusitis

MAYURI J S1 site in 1 country20 target enrollmentStarted: June 16, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
MAYURI J S
Enrollment
20
Locations
1
Primary Endpoint
Change in Visual Analogue Scale (VAS) Score In Headache

Overview

Brief Summary

Chronic rhinosinusitis (CRS) is a chronic inflammatory disease of nasal and paranasal sinus mucosa, where symptomatology has continued beyond 12 weeks. It is a multifactorial disease caused by infection or inflammatory process. Structural deformities obstructing sinus ostia, smoking, snuff dipping, prolonged intra nasal medications, primary and acquired immune deficiency, primary ciliary dyskinesia, cystic fibrosis are the predisposing factors of chronic rhinosinusitis.1 The infection results in mucosal swelling with obstruction of the sinus ostia. Due to inflammation mucous that become more viscous. These changes in the nasal-sinus environment leads to mucostasis and bacterial colonization. The cardinal symptoms of chronic rhinosinusitis are headache, nasal obstruction, nasal or postnasal purulent discharge,facial pain and pressure, disturbance of smell. The clinical presentation of chronic rhino-sinusitis indicates an excess of kapha-vata dosha in the upper respiratory tract, which shares similarities with the symptomatology of dushtapratisyaya. In this condition there is increased dosha vitiation and uttarothara dhatu dushti. Therefore, it is essential to undergo a sodhana therapy to eliminate the excess dosha. 20 patients within the age group of 18-50 years diagnosed with CRS selected on the basis of inclusion criteria, attending OPD and IPD of Shalakyatantra, Govt.Ayurveda College, Thiruvananthapuram will be subjected to Marsha nasya with shirovirechana gana taila for 7 days followed by mundoupakulyadi Kashaya pana for the next 14 days. Clinical evaluation and investigations will be done prior to the commencement of intervention, 8th day and 22 th day.Follow up will be done after 2 weeks to access any recurrence of the disease. Results will be statistically analysed after the study by Kruskal-wallis test.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • a) Clinically Diagnosed Cases Of Chronic Rhino-Sinusitis With Symptoms Headache, Nasal Obstruction, Nasal or Postnasal Purulent Discharge, Loss Of Smell, Facial Pain and Pressure.
  • b) Participants Between Age Group Of 18-50 Years irrespective of gender, religion and socioeconomic status.
  • c) Participants who are suitable for nasya.

Exclusion Criteria

  • a) Diagnosed Cases Of Pan sinusitis, Middle Ear Infection.
  • b) Participants Diagnosed With Any Other Forms Of Headache Such As Migraine, Tension Headache And Trigeminal Neuralgia.
  • c) Pregnant And Lactating Mothers d) Those Contraindicated For Nasya.
  • e) Diagnosed Cases Of TB On Medication.
  • f) Participants With History Of Multiple Episodes Of Epistaxis, Disorders Of Blood Coagulation And Malignancy.
  • g) Participants With History Of Major Brain Surgery.
  • h) Participants With History Of Traumatic Injury Of Brain And Diagnosed Cases Of Cerebro-Vascular Accidents.
  • i) Participants With History Of Status Asthmaticus j) Participants Diagnosed With Nasal Polyp And With Severely Neviated Nasal Septum.

Outcomes

Primary Outcomes

Change in Visual Analogue Scale (VAS) Score In Headache

Time Frame: 2 Months

Change In Sino Nasal Outcome Test (SNOT 22) For, Nasal Obstruction, Nasal or Postnasal Purulent Discharge, Loss Of Smell, Facial Pain And Pressure.

Time Frame: 2 Months

Secondary Outcomes

  • Change in score values of X-ray PNS graded by using Lund Mackay Scale(0 No haziess)

Investigators

Sponsor
MAYURI J S
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Mayuri J S

Government Ayurveda College Thiruvananthapuram

Study Sites (1)

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