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Clinical Trials/CTRI/2023/03/051156
CTRI/2023/03/051156Not yet recruitingNot Applicable

Therapeutic evaluation of the unani formulation in management of warm tajaweef-e- anaf muzmin -A randomised open study with placebo

Department of moalejat Ajmal khan tibbiya college Aligarh Muslim university Aligarh1 site in 1 country60 target enrollmentStarted: May 4, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
improvement in Objective parameters

Study Overview

Brief Summary

Chronic sinusitis is characterised by nasal discharge ,obstruction,sneezing,headche which often necetitates the patients to undergo modern interventions such as use of anti histaminics, analgesics for long term use and later on surgical intervention. Under such circumstances ,unani system boasts to have a treasure of safe and effective unani drugs with minimal side effects.In order to reduce the cost of management of chronic sinusitis in all aspects and reduce the side effects of modern medicines,this trial consisting of decoction of gul e banafsha,barg e gaozaban,tukhme khatmi,tukhme khubbazi,unnab has been designed to evaluate the efficacy of nuskha joshanda nazla barid in patients of chronic sinusitis.

Study Design

Study Type
Interventional
Allocation
Random Number Table
Masking
Not Applicable

Eligibility Criteria

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

Inclusion Criteria

  • Clinically diagnosed patients of chronic sinusitis through objective parameters[Assessment of opacity and Assessment of mucosal thickening by xray pns w/v] and subjective parameters[
  • Nasal Obstruction
  • Nasal discharge
  • Headache 5.Post nasal drip 6.Abnormalites of smell 7.Heaviness in head
  • Tenderness of sinuses] Patients of both sexes.
  • Patients in the age group of 20 to 60 years.
  • Those who give written consent.

Exclusion Criteria

  • Patients below 20 years of age.
  • Patients above 60 years of age.
  • Pregnant & lactating mothers.
  • Patients who fail to give consent.
  • Patients who fail to follow up.
  • Mentally retarded persons.
  • •Patients of diabetes mellitus or any comorbid disease.
  • •Malignancy of nose and paranasal sinuses.
  • •Patients having any history of trauma to nose or sinus area, any surgery of nose or paranasal sinuses.
  • •Patients having any congenital and acquired structural abnormality of the nasal cavity.
  • •Any medical condition where physician feels that participation in the study could be detrimental to patient well being.

Outcomes

Primary Outcomes

improvement in Objective parameters

Time Frame: 45 days with basline and after completion.

opacity

Time Frame: 45 days with basline and after completion.

Assessment of

Time Frame: 45 days with basline and after completion.

mucosal

Time Frame: 45 days with basline and after completion.

thickening through arbitary grading

Time Frame: 45 days with basline and after completion.

Secondary Outcomes

  • improvement in Subjective parameters(1. Nasal Obstruction)

Investigators

Sponsor
Department of moalejat Ajmal khan tibbiya college Aligarh Muslim university Aligarh
Sponsor Class
Government medical college

Study Sites (1)

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