Clinical Trial of PIHF in improving immunity.

Not Applicable

Completed

• Registration Number: CTRI/2021/03/032208
• Lead Sponsor: aturedge Beverages Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-08
• 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)

Ready to provide written informed consent

With or without propensity of seasonal cough, cold and allergic episodes

Willing to come for the follow-up visits for evaluation

Exclusion Criteria

Presence of clinically significant known abnormal laboratory, ECG or X-ray findings during screening.

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

Subject consuming more than 1 cigarette per day

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate changes in number of episodes, severity and duration of illness during the study period <br/ ><br>To evaluate changes in blood cell count through Complete Hemogram <br/ ><br>To evaluate changes in symptoms like cough, breathlessness etc. if any infection episode.Timepoint: Screening day, baseline, day 15 and day 30

Secondary Outcome Measures

Name	Time	Method
Digestive behavior questionnaire analysis <br/ ><br>Assessment of energy audit questionnaire <br/ ><br>Assessment of quality of life (QoL) <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 reactionsTimepoint: Screening day, baseline, day 15 and day 30