Health Condition 1: null- chronic or recurrent, non-infective nasal congestion with-or-without rhinorrhea
Conditions
Interventions
Intervention1: E-RH-06: Properiatary blend of Emblica officinalis, Tinospora cordifolia, Capparis spinosa, Aloe vera, Piper longum and Zinc.
Recommended in dose of 1to 2 capsules BD orally for 12 week
Sponsors
Enovate Biolife Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ? Male and female subjects in the age group of 18-60 years with per-sistent or recurrent nasal congestion and/ or rhinorrhea as defined by the symptoms that last for not less than an hour. ? Demonstrating baseline average 24 hour TNSS ≥10. ? No clinical evidence of infection indicated by mucopurulent or puru-lent discharge, fever, and tenderness over paranasal sinuses. ? Subjects who will be able to read and fill-up subject diary efficiently. ? Able and willing to give informed consent. ? Able and willing to follow all study related instructions and to make all required visit
Exclusion criteria
Exclusion criteria: ? Subjects who have taken systemic, topical corticosteroids, long acting antihistamines or immunosuppressive medication within last 4 weeks or planning to take them within the course of the study. ? Acute febrile illness (such as cold, flu etc.) within one week of enroll-ment. ? Subjects with nasal structure deformities, nasal polyps, severe de-viated nasal septum and hypertrophic rhinitis will be excluded from the study. ? Clinical history of allergy/ hypersensitivity to one or more products of herbal origin. ? Pregnant / lactating women and women who are planning to get preg-nant ? Recent (within last 3 months) participation in a clinical trial ? Recent (within last 15 days) use of any herbal product for the indication under study ? Patients with severe conditions of chronic sinusitis deviated nasal sep-tum or nasal polyposis. ? Bronchial asthma patients on loading/ maintenance therapy of theophy-line. ? Patients requiring continuous use of laxatives. ? Major chronic disease of liver, kidney, CVS or CNS and other body systems ? A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient?s medical history, which in the Investigator?s opinion may pose a threat to patient compliance. ? Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if the investigational product E-RH-06 relieves the symptoms of nasal congestion with-or-without rhinorrhea to a greater extent than placebo with 12 weeksâ?? treatment as assessed by the pre-visit 24 hours reflective TNSSTimepoint: To determine if the investigational product E-RH-06 relieves the symptoms of nasal congestion with-or-without rhinorrhea to a greater extent than placebo with 12 weeksâ?? treatment as assessed by the pre-visit 24 hours reflective TNSS | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?? Reduction in TNSS at the end of 4 weeks as compared to baseline ï?? Reduction in Total Symptom Score (TSS) and/or Total Non Nasal Symptom Score (TNNSS) at the end of 4 weeks as compared to baseline ï?? Reduction in frequency of AR attacks at the end of 4 weeks as compared to baseline Timepoint: 4 weeks | — |
Countries
India
Contacts
Public Contactshalini srivastava
Enovate Biolife Pvt Ltd
Outcome results
None listed