A small scale clinical study to understand safety and effectiveness of Respikshar-Y25 in patient of Asthma.

A pilot, exploratory clinical study to evaluate the safety and efficacy of Respikshar-Y25 tablet in the patients with Asthma - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075549

Enrollment

Registered

2024-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J452- Mild intermittent asthma Health Condition 2: J453- Mild persistent asthma Health Condition 3: J454- Moderate persistent asthma

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients presenting with mild or moderate cases of Asthma irrespective of sex, aged between 18 years to 65 years will be considered. History of Asthma less than 5 year. Peak Expiratory flow rate more than 80 lit/min and less than 300 lit/min.

Exclusion criteria

Exclusion criteria: Asymptomatic Asthma patients Known case of other respiratory illness The patients who had history of uncontrolled diabetes and uncontrolled systemic arterial hypertension, other systemic illness Chronic cigarette smokers Individuals with known allergies to ingredients of interventional drug Pregnant or breastfeeding women Patient in status asthmaticus

Design outcomes

Primary

Measure	Time frame
To observe changes in Peak expiratory flow rate (PEFR) value after treatment in Asthma patients compared with base line values.Timepoint: 4 weeks	—

Secondary

Measure	Time frame
1. To observe changes in respiratory rate, Absolute Eosinophil Count, Erythrocyte Sedimentation Rate (ESR), Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire after treatment in Asthma patients compared with base line values.Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactDr Vatsal L Dhudashiya

Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune-18

mrudula.joshi@dpu.edu.in9226279270

Outcome results