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

Dr Deepali Gaikwad0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•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.

•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.

发起方

Dr Deepali Gaikwad