Health Condition 1: null- Allergic Rhinitis Health Condition 2: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: IND02: IND02 capsules (350 mg, one capsule, twice a day) OR IND02 nasal spray (one shot , 100 microgram/100 microliter in each nostril, twice a day) for 4 weeks
Control Intervention1: P
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: • Written informed consent. • Diagnosis of persistent or seasonal allergic rhinitis • RQLQ score of >=2 and • Women with childbearing potential, willing to use effective contraceptive measures such as oral contraceptive or intra-uterine device. • In the opinion of the investigator, able to comply with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: • Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study. • Females who are pregnant, lactating or planning to become pregnant. • Clinically significant laboratory test results, as judged by the investigator. • Patients who are scheduled to receive any other investigational drug during the course of the study • Clinical evidence of bacterial sinusitis. • Associated chronic diseases like hypertension, ischemic heart disease, diabetes, psychiatric; any cancer and CNS disorders. • Alcoholics and drug addicts including smokers. • Within 6 weeks of having steroid therapy. • Patients having discomfort with nasal spray containing ethyl alcohol (ethanol)Patients having allergies with ethyl alcohol (ethanol) • Asthmatic patients using or used last 3 months inhaled or oral corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual or total score using the Juniper rhinoconjuctivitis quality of life questionnaire (RQLQ)Timepoint: At screening visit, recruitment (baseline), Week-2, Week-4 and week-8 (follow-up) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Individual Nasal Symptoms score (NSS) or Total NSS (TNSS), Daily Sleep interference scale, WPAIâ??AS score Safety: Spirometry Measurements, Hematology, ECG, Vital signs, AE monitoring, Laboratory safety measurements (biochemistry, urine routine and ESR).Timepoint: At screening visit, recruitment (baseline), week-2, week-4, week-8 (follow-up) | — |
Countries
India
Contacts
Public ContactDr Prasad Thakurdesai
Indus Biotech Private Limited
Outcome results
None listed