Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2015/09/006198
CTRI/2015/09/006198
Completed
N/A

Assessment of Efficacy, Safety and Tolerability of therapy with fixed dose combination (FDC) of Cetirizine with Ambroxol and Ambroxol as monotherapy in the treatment of productive Cough: An Open-label, Prospective, Multi-centre, Observational Study

Dr Reddys laboratories Ltd0 sites250 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: null- productive cough (cough with expectoration) associated with any of the nasal symptoms (nasal discharge,nasal stuffiness, nasal itching, and Sneezing) since at least previous 8 hours

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Condition 1: null- productive cough (cough with expectoration) associated with any of the nasal symptoms (nasal discharge,nasal stuffiness, nasal itching, and Sneezing) since at least previous 8 hours
Sponsor
Dr Reddys laboratories Ltd
Enrollment
250
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Children between over 6 to 18 years of age
  • •2\. Male and female children
  • •3\. Children having productive cough (cough with expectoration)
  • •associated with any of the nasal symptoms (nasal discharge,
  • •nasal stuffiness, nasal itching, and Sneezing) since at least
  • •previous 8 hours
  • •4\. Child willing to provide assent and parents/guardian willing
  • •to provide written informed consent
  • •5\. Willing and able to understand and comply with all study
  • •requirements

Exclusion Criteria

  • •1\.Use of any throat lozenge, throat spray, cough drop, menthol\-containing product, or any product with demulcent properties within last 8 hours
  • •2\.Use of any cold medication (e.g. nasal or systemic decongestants, antihistamine, expectorant, anti\-tussive) within last 8 hours
  • •3\.Severe cough requiring hospitalization
  • •4\.Presence of fever within last 8 hours
  • •5\.Active pulmonary disease such as bronchopneumonia, bronchial asthma or tuberculosis
  • •6\.Known allergy to and/or hypersensitivity to ambroxol and/or cetirizine
  • •7\.Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
  • •8\.Use of any investigational therapy within 30 days prior to randomization
  • •9\.Child not willing to provide assent and parents/guardian not willing to provide written informed consent

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 4
A Clinical trial to study the effects and tolerability of Dacne gel containing Clindamycin Phosphate 1% and zinc acetate in patients suffering from acne.
CTRI/2011/091/000041Glenmark Pharmaceuticals Ltd125
Completed
Phase 4
Assessment of Efficacy, Safety and Tolerability of Fixed Dose Combination Wunder Eye Cream (3% Biophytex LS 8740 an 5% Proteasyl TP LS 8657) in the treatment of under Eye Dark Circles.
CTRI/2011/04/001672Glenmark Pharmaceuticals Limited20
Completed
Phase 4
A clinical trial to study the effect of Hair4U 10% containing (minoxidil 10% plus Aminexil 1.5%)in treatment of male pattern of baldnessHealth Condition 1: null- Androgenetic Alopecia
CTRI/2011/06/001813Glenmark Pharmaceuticals Ltd75
Completed
Phase 4
Study of Efficacy, Safety and Tolerability of Na-Picosulphate in patients requiring anorectal surgeryHealth Condition 1: null- Patients requiring bowel preparation for gastrointestinal or anorectal surgery
CTRI/2016/09/007292VYAS SURGERY100
Recruiting
Phase 4
Assessment of Steroneo Skin Cream (Physalis Angulata Supercritical Extract) application for treatment of eczematous lesions
CTRI/2016/11/007511Rehmat Clinic50