Clinical research of siddha medicine SUKKATHI CHOORANAM and INJI THYLAM in the treatment of‘KABHAPEENISAM’ (SINUSITIS)

Phase 3

Not yet recruiting

• Conditions: KABHA PEENISAM (SINUSITIS)

• Registration Number: CTRI/2013/12/004265
• Lead Sponsor: AYOTHIDOSS PANDITHAR HOSPITAL

Brief Summary

It is a single, non-randomized, open-label trial to determine the efficacy and safety of SUKKATHI CHOORANAM in patients with KABHA PEENISAM (SINUSITIS).In this trial 40 sinusitis patients will be recruited and the trial drug will be administered 1.5 gm twice a day along with cow’s ghee for a period of 24 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2013-12-26
• Study Start: 2014-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• •Age :18-50Yrs •Sex – Both male & female •The symptoms of pain in the face, purulent nasal discharge, and headache/heaviness of head, sneezing, fever, tooth ache, nasal block, and presence of any three symptoms will be taken as inclusion criteria.
• •Patient willing to sign the informed consent stating that he/she will conscientiously stick to the treatment during 24 days but can opt out of the trial of his/her own conscious discretion.
• •Patients who are willing for radiological investigation (X-ray for Paranasal sinuses) and provide blood, urine for lab investigation.

Exclusion Criteria

Bronchial asthma Tuberculosis Diabetes mellitus Hypertension Heart disease Chronic obstructive pulmonary disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome is mainly assessed by laboratory and clinical symptom scoring.	Pre study screening and after treatment

Secondary Outcome Measures

Name	Time	Method
Clinical assessments	Pre study screening and after treatment

Trial Locations

Locations (1)

AYOTHIDOSS PANDITHAR HOSPITAL; 🇮🇳 Kancheepuram, TAMIL NADU, India

AYOTHIDOSS PANDITHAR HOSPITAL

🇮🇳Kancheepuram, TAMIL NADU, India

DR V MANOPRIYA

Principal investigator

9791637927

manopriyanis@gmail.com