To see the efficacy of Ayurveda Management in Chronic Rhinosinusitis

Evaluation of efficacy and safety of Shadbindu Taila Marsha Nasya and Chitraka Haritaki Avaleha in Chronic Rhinosinusitis: A Randomized Controlled Multicenter Study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091420

Enrollment

160

Registered

2025-07-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J329- Chronic sinusitis, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between the age group of 18 to 60 years. 2. Patients suffering with Pinasa (Chronic Rhinosinusitis) who are fulfilling the diagnostic criteria based on American system of Academy (AAO-HNS) will be selected for the present study. (a). Twelve weeks or longer of two or more of the following signs and symptoms: Mucopurulent drainage (anterior, posterior or both), Nasal obstruction (congestion), Facial pain-pressure-fullness Decreased sense of smell (b). AND inflammation is documented by one or more of the following findings: Purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region, Polyps in nasal cavity or the middle meatus, and/or Radiographic imaging showing inflammation of the paranasal sinuses 3. Willing to participate in study.

Exclusion criteria

Exclusion criteria: 1. Patients below 18 and above 60 years of age. 2. History of chronic nasal or upper respiratory tract symptoms or disorders other than Chronic Rhinosinusitis. 3. Patients suffering with tonsillitis/adenoids. 4. Patients who are on treatment with H1 antihistamine medication, non-steroidal analgesics, Leukotriene antagonists. 5. Cases of fungal sinusitis (On Non- Contrast CT-PNS; Hypoattenuating mucosal thickening, intranasal/ intrasinus soft tissue attenuation/ opacification, associated osseous erosions, hyperdense fungal hyphae within sinus). 6. Presence of secondary immune deficiency state: HIV, organ transplant, Malignancy, Treatment with corticosteroids. 7. Known cases of Hepatitis B and C positive. 8. Pregnancy & Lactation. 9. Patients suffering from chronic debilitating disease like tuberculosis, rheumatoid arthritis, Pulmonary Dysfunction (Bronchial Asthma and / or

Design outcomes

Primary

Measure	Time frame
Primary Outcome: The change in terms of SNOT-22 score (Sino-Nasal Outcome Test)Timepoint: On base line, 56th day, 84th day	—

Secondary

Measure	Time frame
The change in RSDI score (Rhinosinusitis Disability Index)Timepoint: On base line 56th day 84th day;Lund-Mackay scores of computed tomography (CT) scan of paranasal sinusesTimepoint: On base line, 56th day;Change in the laboratory safety parameters from baselineTimepoint: baseline, 56TH Day;Dependence on rescue medicinesTimepoint: On base line, 14th day, 28th day, 42th day, 56th day;Incidence of treatment emergent adverse eventsTimepoint: On base line, 14th day, 28th day, 42th day, 56th day	—

Measure

Time frame

The change in RSDI score (Rhinosinusitis Disability Index)Timepoint: On base line 56th day 84th day;Lund-Mackay scores of computed tomography (CT) scan of paranasal sinusesTimepoint: On base line, 56th day;Change in the laboratory safety parameters from baselineTimepoint: baseline, 56TH Day;Dependence on rescue medicinesTimepoint: On base line, 14th day, 28th day, 42th day, 56th day;Incidence of treatment emergent adverse eventsTimepoint: On base line, 14th day, 28th day, 42th day, 56th day

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Countries

India

Contacts

Public ContactDr Pallavi Mundada

RARI Patna

archana06bly@gmail.com7046074206

Outcome results