None listed
Conditions
Interventions
Intervention1: PIHF liquid: 60 ml per day for 30 days
Control Intervention1: Nil: Nil
Sponsors
Naturedge Beverages Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate changes in number of episodes, severity and duration of illness during the study period To evaluate changes in blood cell count through Complete Hemogram To evaluate changes in symptoms like cough, breathlessness etc. if any infection episode.Timepoint: Screening day, baseline, day 15 and day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Digestive behavior questionnaire analysis Assessment of energy audit questionnaire Assessment of quality of life (QoL) Drug compliance Tolerability of study drugs Vitals (radial pulse, blood pressure, respiratory rate, and axial temperature) Adverse events/ Adverse drug reactionsTimepoint: Screening day, baseline, day 15 and day 30 | — |
Countries
India
Contacts
Public ContactDr Veena Deo
Naturedge Beverages Pvt. Ltd.
Outcome results
None listed