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A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY AND EFFICACY of PANKAJAKASTHURI BREATHE EAZY GRANULES AND SYRUP

Phase 4
Conditions
Health Condition 1: J40-J47- Chronic lower respiratory diseasesHealth Condition 2: J20-J22- Other acute lower respiratory infectionsHealth Condition 3: J96-J99- Other diseases of the respiratory systemHealth Condition 4: J30-J39- Other diseases of upper respiratory tract
Registration Number
CTRI/2021/07/034636
Lead Sponsor
Pankajakasthuri Herbals India Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Age: 19 Years and above

2.Subjects who have participated in the retrospective cross-sectional PMS of Breathe eazy granules and syrup.

3.Patients willing to take Breathe Eazy granules and syrup in a dose of 1 table spoon twice daily after food continuously for a minimum period of 3 months.

4.Subjects who have started taking Breathe Eazy granules and syrup at least for last 3 months.

5.Subjects willing to enroll in study by signing Informed consent.

6.Subjects presenting with Allergic bronchitis, Allergic rhinitis, COPD, Sinusitis, Eosinophilia and other Respiratory tract infections.

Exclusion Criteria

1.Subjects who have not taken Breathe Eazy granules and syrup in the prescribed dose and duration.

2.Diagnosed patients of Diabetes Mellitus (DM)

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Any marked change in safety parameters measured during the administration of the product. <br/ ><br>â?¢Reporting the effectiveness of this product in the management of Allergic bronchitis, Allergic rhinitis, COPD, Sinusitis, Eosinophilia and other Respiratory tract infections and associated complaints. <br/ ><br>Timepoint: oth-baseline1st-first response to questionnaire and 2nd-response at the end of the study
Secondary Outcome Measures
NameTimeMethod
Additional therapeutic advantages of the productTimepoint: oth-baseline1st-first response to questionnaire and 2nd-response at the end of the study
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