A Randomized Double Dummy Double Blind Dose Determining Place-bo Controlled Study to Evaluate Eff… (NCT01546662) | Clinical Trial Compass
UnknownNot Applicable
A Randomized Double Dummy Double Blind Dose Determining Place-bo Controlled Study to Evaluate Efficacy of Investigational Product E-RH-06 at 2 Dose Levels for the Metabolic Management of Chronic or Recurrent, Non-infective Nasal Congestion With-or-without Rhinorrhea.
India54 participantsStarted 2011-10
Plain-language summary
The study will be conducted in two phases. First phase will be 16 weeks study to assess the safety, efficacy \& to determine the most appropriate dose. Will consist of following visits.
Phase II (Extended Follow-up): At the end of Day 112, an interim analysis will be conducted to assess the sustained efficacy of the investigational product and accordingly the study will enter into phase II.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 visits.
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 deviat-ed 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 lo…