CTRI/2022/03/041394已完成3 期
ââ?¬Å?A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Noscapine and Chlorpheniramine Maleate Oral Syrup in Patients for the Treatment of Dry, Irritating Cough Associated with Running Nose.ââ?¬?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients aged between 12 to 65 years (both inclusive).
- •2. Patients with a diagnosis of dry, irritating cough associated with running nose at screening visit.
- •3. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
- •4. Patient with ability to understand and provide written informed consent / assent form, which must have been obtained prior to screening.
- •5. Patients willing to comply with the protocol requirements throughout the study.
排除标准
- •1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2. Patients who had initiation of allergen immunotherapy within previous 6 months.
- •3. Patients with history of Rhinitis medicamentosa or substantial structural nasal obstruction.
- •4. Patients with the presence of nasal polyps or any clinically important nasal anomaly.
- •5. Patients with the history of acute and/or chronic sinusitis within 30 days of baseline/screening visit.
- •6. Patients with the history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
- •7. Patients with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial.
- •8. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •9. Female patients who are not ready to use acceptable contraceptive methods during the study.
- •10. Patients with known case of HIV, Hepatitis B & C.
- •11. Patients with medical history of oncological conditions.
- •12. Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the patientââ?¬•s participation in the study.
- •13. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit.
- •14. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •15. Patients with suspected inability or unwillingness to comply with the study procedures.
- •16. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
研究者
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