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Symptomatic treatment of patients suffering from productive cough associated with acute bronchitis.

A randomized, open label, active controlled, prospective, single center, two arm, parallel study to assess efficacy, safety and tolerability of combination of NAC 600 mg plus Lactoferrin 50 mg against the NAC 600 mg in the symptomatic treatment of patients suffering from productive cough associated with acute bronchitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045509
Enrollment
60
Registered
2022-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: R05- Cough

Interventions

Intervention1: NAC 600 mg plus Lactoferrin 50 mg: NAC 600 mg plus Lactoferrin 50 mg, per oral, BID for 7 days Control Intervention1: NAC 600 mg: NAC 600 mg, per oral, BID for 7 days

Sponsors

Dr Deepali Gaikwad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female 18 to 60 years and willing to give their written informed consent. 2. Patients with a recent onset of or equal to 2 days of bronchial mucus production with impaired ability to cough up, and a baseline Bronchial Severity Score (BSS) of >=5 score points out of a maximum of 20 points. 3. Patients willing to comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: Patient with known hypersensitivity to any of the components of the formulation. 2. Patient with alcohol or drug dependence. 3. Patient with a history of clinically relevant chronic cardiovascular, kidney, gastrointestinal or liver disease. 4. Patients with antibiotic use in the preceding 2 weeks. 5. Pregnant or lactating women. 6. 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. 7. Patients with a known history/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 03 month.

Design outcomes

Primary

MeasureTime frame
Ease of Cough and Clearance of SputumTimepoint: Week 1

Secondary

MeasureTime frame
Adverse events reported during the studyTimepoint: Day 7;Change in mean Bronchial Severity ScoreTimepoint: Day 7;Change in Patientâ??s General WellbeingTimepoint: Day 7;Improvement in BreathlessnessTimepoint: Day 7;Serious adverse events reported during the studyTimepoint: Day 7

Countries

India

Contacts

Public ContactRakesh Rai

PCMCs PGI Yashwantrao Chavan Memorial Hospital

drdeepali1501@gmail.com9767104004

Outcome results

None listed

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