CTRI/2023/06/053472尚未招募Unknown
A prospective, randomized, double-blind study to evaluate the efficacy of Curcunan® on Upper Respiratory Tract Infections (URTIs) and its recurrence along with its effect on immunity.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
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 and female participants aged 18-50 (both ages inclusive)
- •2. Participants with a BMI >=18.5 and <= 30.0 kg/m2.
- •3. Suffering from URTI i.e., at least 6 URTIs episodes medically confirmed, with a maximum of 12 within 1 Year before the study and must be presenting with the below symptoms of URTI ( < 2 days of onset):
- •i) Runny nose/Nasal congestion
- •ii) Headache
- •iii) Low-grade fever
- •iv) Sneezing.
- •4. Participant must be able & willing to comply with study procedures.
- •5. Participant willing to sign the informed consent.
排除标准
- •1. Known sensitivity to the investigational product or any excipients of the drug product.
- •2. Persistent fever more than 1020F.
- •3. Signs of acute lower respiratory tract disease.
- •4. Current symptoms are mainly induced by other acute ENT diseases.
- •5. Daily use of antibiotics, steroids, and cytotoxic agents.
- •6. Patients on active treatment from any other system of medicine.
- •7. Patients with any uncontrolled systemic disease, infection, and any organ failure.
- •Severe co morbidity including previous malignant disease during the past 3-year prior enrolment.
- •8. Severe or complicated course of URTI (stridor, laryngomalacia, etc.)
- •9. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
- •10. Subjects with COVID infection in the last 30 days.
- •11. Abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapor rub, etc.
- •12. Presence of uncontrolled type 2 diabetes and hypertension.
- •13. Vaccination against influenza or swine flu within 3 months prior to screening
- •14. Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDS (paracetamol) or other medications that are expected to alleviate cold symptoms within two weeks prior to randomization.
- •15. History of any significant neurological and psychiatric condition which may affect the participation and inference of the studyâ??s end points.
- •16. Participation in other clinical trials in the last 30 days prior to screening.
- •17. Participants with 3 months history of chronic smoking, alcohol, or drug abuse.
- •18. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- •19. Any condition that could, in the opinion of the investigator, preclude the participantâ??s ability to complete the study successfully and safely or that may confound study outcomes.
研究者
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