A clinical trial to study the effect of cough mixture syrup of levosalbutamol, ambroxol and guaiphenesin in the treatment of patients suffering from productive cough associated with acute bronchitis.

A randomized, double blind, placebo controlled, prospective, multicentre, two arm, parallel study to assess efficacy, safety and tolerability of cough mixture of Levosalbutamol Sulphate 0.5 mg, Ambroxol Hydrochloride 15 mg and Guaiphenesin 50 mg per 5ml syrup in the symptomatic treatment of patients suffering from productive cough associated with acute bronchitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/03/002477

Enrollment

260

Registered

2012-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Productive Cough Associated with Acute Bronchitis

Interventions

Intervention1: Levosalbutamol Sulphate 0.5mg, Ambroxol Hydrochloride 15mg and Guaiphenesin 50mg per 5 ml syrup: The dose is 10 ml of the syrup three times a day for eight days Intervention2: Ambroxol

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female >=18 to 2. Patients with a recent onset of =5 score points out of a maximum of 20 points 3. Patients willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Patient with known hypersensitivity to any of the components of the formulation. 3. Female patients of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy. 4. Patient with alcohol or drug dependence. 5. Patient with a history of clinically relevant chronic cardiovascular, kidney, gastrointestinal or liver disease. 6. Patients with antibiotic use in the preceding 2 weeks 7. Patients with a concurrent infection including Tuberculosis (TB) requiring antibiotic treatment. 8. Patients with malignant growth or any severe somatopathic, neurologic and / or psychiatric disease. 9. Patient who has clinical laboratory evaluations (including biochemistry, hematology, and complete urinalysis) that are not within the reference range for the testing laboratory at screening and the results are deemed clinically significant by the investigator 10. Patients who have participated in any clinical trial in the past 1 month

Design outcomes

Primary

Measure	Time frame
Ease of Cough and Clearance of SputumTimepoint: 8-days	—

Secondary

Measure	Time frame
1. Improvement in BreathlessnessTimepoint: 8-days;2. Reduction in Sputum VolumeTimepoint: 8-days;3. Decrease in Consistency of SputumTimepoint: 8-days;4. Change in mean Bronchial Severity ScoreTimepoint: 8-days;5. Change in Patientâ??s General Well beingTimepoint: 8-days	—

Countries

India

Contacts

Public ContactDr Shailendra Sachan

Glenmark Pharmaceuticals Ltd

piyusha@glenmarkpharma.com912240189999

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026