Clinical evaluation of the effect on oral administration of a classical siddha drug catakuppai cūraṇam along with external administration of pīṉica tailam in management of headache and running nose

Phase 2

Completed

• Conditions: Acute sinusitis,

• Registration Number: CTRI/2019/07/020150
• Lead Sponsor: Uma Shankari S

Brief Summary

This study is designed as a single arm trial to determine the efficacy of  catakuppai cÅ«raṇam (Internal)  and  pÄ«ṉica tailam (External)  in patients with  nÄ«rpÄ«ṉicam .The outcome will measured by day 1 ,week 1 and week 2 intervals.During this trial period if an adverse effects and serious adverse effects will be noticed and  referred to Pharmocovigilance Department in Government Siddha Medical College and Hospital-Palayamkottai and further management will also be given in Department of Kuzhanthai Maruthuvam OPD and IPD .After completion of the trial all the study related data will be analyzed statistically.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Last Update Posted: 2020-06-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subjects with any of the following symptoms will be included in the study 1.
• Nasal congestion 2.
• Purulent and watery nasal discharge 3.
• Pain and tenderness around the nose, orbit and maxillary region 4.
• Cough and sneezing Subject should be ready to comply with the treatment protocols.

Exclusion Criteria

• Subjects with 1.
• Severe and recurrent epistaxis due to sinusitis 2.
• Rhinitis due to tuberculosis 3.
• Any congenital anomalies 4.
• Rhinosporidiasis will be excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reducing nasal congestion, Purulent and watery nasal discharge, Pain and tenderness around the nose, orbit and maxillary region, Cough and sneezing	Day 1 & Week 1

Secondary Outcome Measures

Name	Time	Method
Assessed by SNOT-22	2 Weeks

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital, Palayamkottai; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital, Palayamkottai

🇮🇳Tirunelveli, TAMIL NADU, India

Uma Shankari S

Principal investigator

7339230907

saus1494@gmail.com