CTRI/2021/02/031425
Completed
N/A
A pilot, prospective, interventional study assessing safety and efficacy of HFIM â?? 01 in improving respiratory immunity. - NI
Siddhayu Ayurvedic Research Fdn Pvt Ltd0 sites30 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Siddhayu Ayurvedic Research Fdn Pvt Ltd
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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