CTRI/2020/09/028124尚未招募4 期
A Prospective, Single-center, Open-label, Randomized, Parallel group, Active-controlled ClinicalStudy to Evaluate the Efficacy and Safety of Cefpodoxime Proxetil 200 mg + Clavulanic acid125 mg versus Amoxicillin 500 mg + Clavulanic acid 125 mg in the Treatment of patients withUpper Respiratory Tract Infections.
Dr Rajendra Bohra0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Adult male or female patients aged between 18 to 65 years of age (both ages inclusive)
- •2. Diagnosed with URTIs with presence of at least four of the following signs and symptoms:
- •-Runny nose
- •-Nasal congestion
- •-Chilliness
- •-Scratchy throat
- •-Sore throat
- •-Hoarseness
- •-Post nasal drip
- •-Purulent rhinorrhea
- •-Difficulty in swallowing
- •3. Women of childbearing potential must be willing to consistently use an appropriate method of contraception
- •4. Willingness to give their written informed consent to participate in the study
- •5. Willingness to comply with all aspects of the protocol
排除标准
- •1. Patients with known hypersensitivity to active or inactive ingredients of the IP or other β-lactams (e.g., penicillins and cephalosporins) except study treatment.
- •2.Patients with known history of clostridium difficile-associated diarrhea
- •3. History of renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, serum sickness-like reaction, hemorrhage, agranulocytosis, and pancytopenia
- •4. History of patients with mononucleosis
- •5. Present chronic inflammatory ENT and respiratory tract disease
- •6. Obstructive anatomic lesions in the nasopharynx
- •7. Patients with severe or complicated course of the URTIs
- •8. Patients with signs of acute lower respiratory tract disease
- •9. Current symptoms mainly induced by other acute Ear-Nose-Throat (ENT) disease
- •10. Female patient with vaginal fungal infections or vulvovaginal infection
- •11. Current indication for administration of or treatment with antiviral drugs.
- •12. Treatment with glucocorticosteroids, immunomodulators, or antihistamines during the past 4 weeks prior to or at enrolment as well as current indication requiring these drugs during the trial.
- •13. Patients requiring hospitalization or parenteral antibiotic treatment.
- •14. Patients who have received any antibiotic treatment within 2-3 days prior to enrollment in the study.
- •15. Heavy smoking, alcohol abuse or known or suspected drug addiction.
- •16. Female patients who are pregnant or lactating or planning to become pregnant.
- •17. Evidence or history of clinically significant medical or surgical abnormality including clinically significant laboratory parameters that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study.
- •18. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study
研究者
相似试验
尚未招募
4 期
To Evaluate the Efficacy and Safety of Bio-D3® Plus Vs Shelcal® of Patients with Osteoporosis of lumber spineCTRI/2020/10/028767Dr Pravin Markade
尚未招募
4 期
To Assess Efficacy and Safety of Enzomac in patients with OsteoarthritisCTRI/2020/03/024039Dr Aniket Nitinkumar Shah
尚未招募
4 期
A Clinical Study to evaluate the effect and safety of Flexabenz Gel versus Volini Gel in the treatment of Patients with Low Back Pain due to Osteoarthritis of Lumbar SpineCTRI/2020/04/024588Dr Rahul Thakare
尚未招募
不适用
Study to compare efficacy and safety of trypsion plus bromelain plus rutoside tablet along with cefuroxime axetil tablet versus cefuroxime axetil tablet given alone in patients with surgical wound after minor surgeryCTRI/2020/08/027070okmanya Medical Research Center
尚未招募
4 期
Observational study to evaluate safety and effectiveness of approved combination of medicines in participants with Insomnia & Sleep Disorder.CTRI/2024/07/071200inux Laboratories Private Limited