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Clinical Trials/CTRI/2022/11/047215
CTRI/2022/11/047215Not yet recruitingPhase 2

PHASE II NON RANDOMISED OPEN CLINICAL EVALUATION OF SIDDHA MEDICINE SEVVIYADHI CHOORANAM FOR THE MANAGEMENT OF AZHAL THALAINOKKADU (SINUSITIS)

SSHAMSHALNIHA1 site in 1 country40 target enrollmentStarted: November 15, 2022Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
The outcome will be mainly assessed by reduction in clinical symptoms after the treatment and assessing the improvement of the patient from severe to moderate, moderate to mild through ADELAIDE Symptom Severity Score which helps to ensure the wellness of the patient.

Study Overview

Brief Summary

Sinusitis is the inflammation of sinuses, which are air filled cavities in the skull. It can be acute or chronic. Types of sinuses are maxillary, frontal,ethmoid and sphenoid. The maxillary sinuses are mostly involved. The condition in which all the sinuses involved is called Pansinusitis.In Siddha system of medicine there are many unique combination of medicines which have solution to present scenario of Sinusitis. One such combination is SEVVIYADHI CHOORANAM which will be cost effective and reliable. The method of preparation of medicine is easy and raw drugs are easily available.

The aim of this study is the management of AZHAL THALAINOKKADU( SINUSITIS) with the Siddha medicine SEVVIYADHI CHOORANAM and the objective is to determine the therapeutic efficacy and safety profile of Siddha medicine SEVVIYADHI CHOORANAM in the treatment of AZHAL THALAINOKKADU (SINUSITIS).

The ingredients of the formulation used for current study posses various pharmacological activities. As the literary evidences support the usage of drugs in the disease,hypothesis is created in such a way that the efficacy of SEVVIYADHI CHOORANAM will be better solution for the management of AZHAL THALAINOKKADU (SINUSITIS)

Study Design

Study Type
Interventional
Allocation
Not Applicable
Masking
Open Label

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Rhinorrhoea Head ache Pain and tenderness over Paranasal sinus Nasal congestion.

Exclusion Criteria

  • Rhinorrhoea Head ache Pain and tenderness over Paranasal sinus Nasal congestion.

Outcomes

Primary Outcomes

The outcome will be mainly assessed by reduction in clinical symptoms after the treatment and assessing the improvement of the patient from severe to moderate, moderate to mild through ADELAIDE Symptom Severity Score which helps to ensure the wellness of the patient.

Time Frame: Within a period of 48 days.

Secondary Outcomes

  • Reduction in symptoms will be assessed(WITHIN A PERIOD OF 48 DAYS)

Investigators

Sponsor
SSHAMSHALNIHA
Sponsor Class
Other [self]

Study Sites (1)

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