Health Condition 1: null- Adult patients with recurrent upper respiratory tract infections
Conditions
Interventions
Intervention1: Capsule Immunrich one capsule twice daily: one capsule twice a day for 12 weeks
Control Intervention1: Placebo: one capsule twice a day for 12 weeks
Sponsors
Charak Pharma Pvt Ltd CPPL
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria The participant may enter the trial if ALL of the following apply: Adult patient of either gender within age range of 18 to 70 years Participant is willing and able to give informed consent for participation in the trial Patients with greater than 1 yearâ??s history of recurrent( more than 3 episodes) or chronic upper respiratory infections with the presence of at least two of the following Rhinitis Pharyngitis Cough Pyrexia with body temperature more than 38.5oC Participant has clinically acceptable laboratory results In the Investigatorâ??s opinion, is able and willing to comply with all trial requirements
Exclusion criteria
Exclusion criteria: Exclusion Criteria The participant may not enter the trial if ANY of the following apply: Patients suffering from any severe metabolic, neurological or cardiovascular disorder Patients taking any other medicine on long term basis Patients suffering from lower respiratory tract infections Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial Participants who have participated in another research trial involving an investigational product in the past 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of Capsule Immunrich in recurrent upper respiratory tract infectionsTimepoint: To study the efficacy of Capsule Immunrich in recurrent upper respiratory tract infections | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess immunological activity of Capsule Immunrich compared with placebo in patients with recurrent respiratory tract infections 2.To assess safety and tolerability of Capsule Immunrich compared with placebo in patients with recurrent upper respiratory tract infections Timepoint: 1.Number of patients showing improvement in laboratory investigations after 12 weeks of treatment 2.Investigatorâ??s global assessment 3.Patientsâ?? global assessment 4.Patientsâ?? reporting and Investigatorâ??s assessment of adverse reactions (AR) | — |
Countries
India
Contacts
Public ContactDr Aparna Sathe
Y.M.T Ayurvedic Medical College, Kharghar, Navi Mumbai
Outcome results
None listed