Evaluate safety and efficacy of HFIM â?? 01 in improving respiratory immunity.

Not Applicable

Completed

• Registration Number: CTRI/2021/02/031425
• Lead Sponsor: Siddhayu Ayurvedic Research Fdn Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Male and female subjects aged 18 to 60 years (both the ages inclusive)

With or without recurrent upper respiratory tract infection or seasonal asthma

Ready to provide written informed consent

No history of any known allergy with herbal products or any of the ingredients of the test product

Willing to come for the followup visits for evaluation

Exclusion Criteria

Patients with known uncontrolled diabetes mellitus (DM) HbA1C more than 7.5 hypertension (HT) symptomatic congestive heart failure (CHF) unstable angina pectoris myocardial infarction (MI)

Subjects with current medical history of any major illness such as cancer, heart disease, COPD, Asthma etc. in the past

Patients participated in another clinical drug trial within 3 months before recruitment in this trial

Any other medical condition that in the Investigators opinion would preclude patient participation

Pregnant and breast feeding women and women of child bearing age refusing to use contraceptive measures

Immunologically compromised individuals

Subjects with past history of addiction abuse and rehabilitation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objectives of study are to evaluate changes in <br/ ><br>Number of episodes severity and duration of illness during the study period <br/ ><br>Complete Hemogram <br/ ><br>Serum IgG IgM <br/ ><br>Levels of CD3 and 4 and 8 cells <br/ ><br>Assessment of quality of life (QoL) <br/ ><br>Timepoint: From baseline to end of the study <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Secondary objectives of study are to evaluate changes in <br/ ><br>Digestive behavior questionnaire analysis <br/ ><br>Assessment of fatigue lethargy using Fatigue Severity Scale (FSS) <br/ ><br>Drug compliance <br/ ><br>Tolerability of study drugs <br/ ><br>Vitals (radial pulse blood pressure respiratory rate and axial temperature) <br/ ><br>Adverse events/ Adverse drug reactions <br/ ><br>Timepoint: From baseline to end of the study