None listed
Conditions
Interventions
Intervention1: HFIM â?? 01: HFIM â?? 01 at the dose of 10 ml twice a day for 30 days
Control Intervention1: NIL: NIL
Sponsors
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives of study are to evaluate changes in Number of episodes severity and duration of illness during the study period Complete Hemogram Serum IgG IgM Levels of CD3 and 4 and 8 cells Assessment of quality of life (QoL) Timepoint: From baseline to end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of study are to evaluate changes in Digestive behavior questionnaire analysis Assessment of fatigue lethargy using Fatigue Severity Scale (FSS) Drug compliance Tolerability of study drugs Vitals (radial pulse blood pressure respiratory rate and axial temperature) Adverse events/ Adverse drug reactions Timepoint: From baseline to end of the study | — |
Countries
India
Contacts
Public ContactMr Sharad Dhurde
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Outcome results
None listed