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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- 1. Change in quality of life by WURSS-21 questionnaire in comparison to placebo
研究概览
简要总结
Thisis a randomized, double-blind placebo-controlled study to assess the efficacyand safety of Curcunan® in the management of Upper Respiratory Tract Infection (URTI). The studywill be conducted in male and female patients between the ages of 18-50 years(inclusive of both the ages). Screening data will be reviewed to determine participant’seligibility. Patients who meet all inclusion criteria and exclusion criteriawill be enrolled in the clinical study.
Atotal of 64 participants will be enrolled in the clinical study and randomizedinto either of the 2 groups in the ratio of 1:1, Group A: Curcunan® and Group B: Placebo. Each enrolled patientwill receive their respective IP, as per the randomisation, from baseline tillday 90. Patients will visit the site for a follow up visit on Day 10 (±3 days),Day 45 (±3 days), and Day 90 (±3 days). Also, a telephonic follow up will bedone on day 30 and day 60 for any recurrence of URTI episodes. For the increasein the severity of the symptoms and for any recurrence of the URTI, thepatients will be prescribed rescue medication (Cetirizine 5mg + Paracetamol325mg + Phenylephrine 10mg BD) as per the discretion of the investigator. Theduration and frequency of the rescue medication will be captured in the CRF andpatient diary.
Onday 90 (±3 days) (Visit 4), the patient will stop consuming the IP. Atelephonic follow up will be done on day 105 for safety and recurrence of URTIepisodes. Patients will visit site on Day 120 (±3 days) for follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants aged 18-50 (both ages inclusive)
- •Participants with a BMI ≥18.5 and ≤ 30.0 kg/m
- •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.
- •Participant must be able & willing to comply with study procedures.
- •Participant willing to sign the informed consent.
排除标准
- •Known sensitivity to the investigational product or any excipients of the drug product.
- •Persistent fever more than 1020F.
- •Signs of acute lower respiratory tract disease.
- •Current symptoms are mainly induced by other acute ENT diseases.
- •Daily use of antibiotics, steroids, and cytotoxic agents.
- •Patients on active treatment from any other system of medicine.
- •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.
- •Severe or complicated course of URTI (stridor, laryngomalacia, etc.)
- •History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
- •Subjects with COVID infection in the last 30 days.
- •Abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapor rub, etc.
- •Presence of uncontrolled type 2 diabetes and hypertension.
- •Vaccination against influenza or swine flu within 3 months prior to screening
- •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.
- •History of any significant neurological and psychiatric condition which may affect the participation and inference of the study’s end points.
- •Participation in other clinical trials in the last 30 days prior to screening.
- •Participants with 3 months history of chronic smoking, alcohol, or drug abuse.
- •Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- •Any condition that could, in the opinion of the investigator, preclude the participant’s ability to complete the study successfully and safely or that may confound study outcomes.
结局指标
主要结局
1. Change in quality of life by WURSS-21 questionnaire in comparison to placebo
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
2. Change in hs-CRP in comparison to placebo.
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
3. Change in Erythrocyte Sedimentation Rate (ESR) in comparison to placebo.
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
4. Change in the severity of Symptoms of URTI episodes as analyzed by WURSS-21 Questionnaire in comparison to placebo.
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
5. Number of days with fever using patient diary in comparison to placebo.
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
6. Duration of usage of any rescue medication using patient diary in comparison to placebo.
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
7. Unscheduled visits to physicians using patient diary in comparison to placebo.
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
8. Absence from work using patient diary in comparison to placebo.
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
9. Hospital admissions (number of days in the hospital and number of hospitalization) using patient diary in comparison to placebo
时间窗: 1. Every day for 10 days during demonstration of symptoms at each episode throughout the study. | 2. Day 1, Day 10, and Day 90. | 3. Day 1, Day 10, and Day 90. | 4. Throughout the study. | 5. Throughout the study. | 6. Throughout the study. | 7. Throughout the study. | 8. Throughout the study. | 9. Throughout the study.
次要结局
- 1.Vitals (Blood pressure, body temperature and pulse rate)(2. Complete Blood Count [Haematology-WBC count, RBC count, haemoglobin, haematocrit, platelet count, differential count (neutrophils, eosinophils, basophils, monocytes, lymphocytes)])