CTRI/2017/09/009643
Completed
Phase 4
A Phase IV , Randomized, Open Label, multicentre study to confirm the safety and tolerability of Alerfix Total (Levocetirizine, Montelukast, Ambroxol) in patients with Non specific respiratory symptoms (NSRS) with Asthma.
Eris Life sciences Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: J459- Other and unspecified asthmaHealth Condition 2: null- Patients with Cough and/or wheeze and/or chronic dyspnoea with asthma.
- Sponsor
- Eris Life sciences Pvt Ltd
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Men or Women, between 18 to 80 years of age (both inclusive).
- •2\.The patient experiencing Cough and/or wheeze and/or chronic dyspnoea or any other symptoms of NSRS with asthma
- •3\.Patient indication and disease condition according to the â??INDICATION \& USAGEâ?? as mentioned in the package insert available with Alerfix Total
- •4\.Women of childbearing potential using an acceptable method of birth control.
- •5\.Willing to give written informed consent for participation in the study and to comply with the study procedures
Exclusion Criteria
- •1\.Evidence of active liver disease or SGPT \> 2\.5 times upper limit of normal (ULN)
- •2\.Evidence of renal impairment (Serum creatinine levels more than 2\.0 mg /dl)
- •3\.Pregnancy
- •4\.Malignancy
- •5\.Contraindication as mentioned in package insert
- •6\.Patients with medical conditions that preclude the follow\-up as defined in the protocol or otherwise limits participation in this study
- •7\.Patients with known history of hypersensitivity to the study drug
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 4
An Observational Post Marketing study to check the safety and tolerance of Atorsave D on patients with hyperlipidemia or statin related myalgia.Health Condition 1: I998- Other disorder of circulatory systemHealth Condition 2: null- Patients with hyperlipidemia or statin related myalgiaCTRI/2017/09/009644Eris Life sciences Pvt Ltd
Active, not recruiting
Not Applicable
A Phase IV, multi-centre, randomized, open label study to investigate the efficacy and safety of Floradix® mit Eisen and ferro sanol® duodenal mite 50 mg in pregnant women with diagnosed iron deficiencyPregnant women with diagnosed iron deficiencyMedDRA version: 12.1Level: LLTClassification code 10022976Term: Iron deficiency anemia secondary to inadequate dietary iron intakeEUCTR2010-018940-15-DESALUS Haus GmbH & Co. KG
Active, not recruiting
Phase 1
Acalabrutinib Monotherapy vs Investigator’s Choice of Treatment in Patients with Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac ImpairmentChronic Lymphocytic Leukaemia and Moderate to Severe Cardiac ImpairmentTherapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]CTIS2023-510147-37-00AstraZeneca AB55
Completed
Phase 4
Immunogenicity and safety of Rabies Vaccine, adimistered with two different simulated post exposure regimensCTRI/2011/07/001857ovartis Healthcare Pvt Ltd250
Active, not recruiting
Not Applicable
A phase IV, randomized, open-label, multi-center study in adults: Evaluation of long-term immunogenicity in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer) in study V48P2E1, 5 years after first booster immunization and Evaluation of booster kinetics in subjects boosted with a new TBE vaccine for adults (free of protein-derived stabilizer), 5 years after first booster immunization. - not availableTBE prophylaxisEUCTR2005-004459-36-DEChiron Behring GmbH & Co KG190