A Clinical Research of Siddha Medicine in the treatment of Sooli Kanam (Childhood Asthma)

Phase 3

Recruiting

• Conditions: Soolikanam (Childhood Asthma)

• Registration Number: CTRI/2017/05/008540
• Lead Sponsor: National Institute of Siddha

Brief Summary

Itis a single, non-randomized, open-label trial to determine the efficacy andsafety of THULASI ENNAI (Prepared from herbal constitutents) in patientswith SOOLI KANAM (CHILDHOOD ASTHMA). In this trial 40 patients willbe recruited and the trial drug will be administered orally twice a dayfor a period of 40 days. During this trial period all the study relateddata will be recorded and documented in a page separate trial master filefor each patients.During the trial period if any AE/SAE/SUSAR will be noticedand referred to pharmacovigilance dept in NIS and further management willalso be given in NIS OPD/IPD.The entire trial will be monitored by theresearch monitoring committee of NIS. During this trial allthe safety and efficacy parameters will be recorded in the CRF. Aftercompletion of the trial all the study related data will be analysedstatistically. The outcome of this trial will be published inIndian Journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-21
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Age : 7 – 12 years 2.Cough 3.Wheezing 4.Tightness of chest 5.Shortness of breath 6.Abdominal bloating 7.Loss of appetite.

Exclusion Criteria

1.Children below 7 years and above 12 years 2.Haemoptysis 3.Pneumonia 4.Congenital heart disease 5.Status Asthmaticus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the trail drug is measured by Peak Expiratory Flow Meter	Before treatment (0th day) and After treatment (40th day)

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is assessed by comparing the following parameters before and after the treatment	1.Improve clinical symptoms

Trial Locations

Locations (1)

National Institute of Siddha; 🇮🇳 Kancheepuram, TAMIL NADU, India

National Institute of Siddha

🇮🇳Kancheepuram, TAMIL NADU, India

Dr S Yavanarani

Principal investigator

04422381314

dr.yavana25@gmail.com