Clinical trial of Adathoda rasayanam for the management of bronchial asthma in children

Phase 2

Completed

• Conditions: Moderate persistent asthma,

• Registration Number: CTRI/2019/05/019294
• Lead Sponsor: Dr P Jayapriya

Brief Summary

It is single non randomized open-label trial to determine the efficacy of Adathoda rasayanam for the management of Soolikanam.In the trial 30 Childhood asthma patients will be recruited and the trial drug Adathoda rasayanam will be administrated orally after food thrice a day.During the study period all the study related data will be recorded and documented in seperate trial master file for each and every patients.During the trial period if the patient develop any adverse effect he/she will be immediately referred to the chairman,pharmaco-vigilance commitee,NIS.If it will be mild event,the patient will be treated in OPD-NIS.If the event will be reserve,the patient will be referred to nearby Government Hospital and will be take over the patient,until he/she will get recovery.The treatment will be provided with free of cost.The entire trial will be monitored by yhe research monitoring commitee of NIS.During this trial all the safety and efficacy parameters will be recorded in CRF.After completion of the trial all the study related data will be analysed statistically.The outcome of this trial willbe publishes in Indian Journal of Medical Research.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-26
• Study Completion: 2020-07-04
• Last Update Posted: 2020-11-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Cough,Wheezing,Tightness of chest,Shortness of breath,Abdominal bloating,Loss of appetite.

Exclusion Criteria

Hemoptysis,Active primary complex,Congenital heart disease,Pneumonia,Status Asthmaticus,Any other serious illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the trial drug is measured by peak expiratory flow meter	28 days

Secondary Outcome Measures

Name	Time	Method
Reduction in the recurrence of the disease and improvement in the quality of life of children,Improvement in clinical symptoms	3 months

Trial Locations

Locations (1)

National institute of siddha; 🇮🇳 Kancheepuram, TAMIL NADU, India

National institute of siddha

🇮🇳Kancheepuram, TAMIL NADU, India

Dr P Jayapriya

Principal investigator

6380680879

drjayapriya93@gmail.com