“A COMPARATIVE, RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, OBSERVATIONAL CLINICAL TRIAL STUDY TO EVALUATE EFFICACY AND SAFETY OF FILMOGEN GLYCEROL THROAT SPRAY CONTAINING CD-CYANIDIN PLANT PREMIX WITH ESSENTIAL OIL VERSUS SALINE SPRAY AS PLACEBO IN THE TREATMENT OF PATIENTS SUFFERING FROM DRY COUGH.â€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- VITROBIO
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Primary Endpoint:
研究概览
简要总结
Theaim of this study is to assess the efficacy and safety of ChSp-Dthroat spray against a placebo saline spray for the treatment of patientssuffering from dry cough in a comparative, randomized, double blind, parallelgroup, observational clinical trial. The effect on dry cough, throat symptom severityscores and requirement of antibiotics will be assessed.
Thiswill be a comparative, randomized, double blind, parallel group, observationalclinical trial study compared to Placebo. The study will begin with screeningevaluation.
Afterscreening, Patients satisfying all the inclusion criteria will be enrolled andrandomly allocated in 2:1 ratio as per randomization schedule to receive testproduct or Comparator product (Placebo-saline solution spray). Treatments willbe allocated to patient by carrying out randomization using SAS Version 9.1.3.Biostatistician of Nexus Clinical Research Ltd. will generate the randomizationschedule. Block Randomization methodology will be employed for generating thelist. Within the block the treatment will be distributed in the ratio of 2:1.
This study is designed to getexploitable results in at least 42 patients in the test group and 21 patientsin the Placebo group. The main endpoint being dry cough, the patients will bescreened suffering from dry cough and related throatsymptoms*.*
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 8.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female, Age between 8 to 65 years old.
- •Patients having dry cough (less than 7 days) of any origin with related symptoms as Throat Pain, throat redness, Throat irritation/itching, (Fever if present) (absence of bronchial mucus/phlegm production) Not under any antibacterial or antiviral treatment before recruitment.
- •Patients ready to abstain from using any drug (which will affect the study outcome) other than Investigational Product for the treatment of the studied condition during the study period (except in cases when patient’s condition worsens as per study physician.
- •In this case, Study physician will decide to prescribe antibiotic, if required).
- •Ready to abstain from administration of any herbal or ayurvedic treatment or gargles directed to ease coughing or throat parameters, tea, coffee.
- •Cooperative and understanding skills.
排除标准
- •Hypersensitivity/ history of allergy to any of the Investigational product’s components.
- •Patients who had taken any medicated confectionary, throat pastille, spray or any product with demulcent properties, any cough medicines or drugs containing antihistamines within last 72 hours prior to screening.
- •Patients taking medications with known cough promoting side effects (e.g., angiotensin converting enzyme inhibitors or angiotensin II receptor blockers) that in the opinion of the investigator are causing symptoms of cough Patients with diagnosis of diseases of pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
- •Patients who had used any local anesthetic within the past 24 hours.
- •Patients who have used a longer acting or slow release analgesic during the previous 24 hours.
结局指标
主要结局
Primary Endpoint:
时间窗: Frequency score at 2 h after the start of treatment on day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to the baseline.
Change in the dry cough severity and frequency score at 2 h after the start of treatment on day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to the baseline.
时间窗: Frequency score at 2 h after the start of treatment on day 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to the baseline.
次要结局
- Change in score of throat pain, throat irritation, throat mucosa redness, swollen throat, fever and effect on swallowing at 5 minutes and 2 h after the 1st application on the days 1, day 2, day 3, day 6, day 9, day 12 and day 15 or up to complete recovery (whichever is earlier) compared to baseline values and compared to the placebo treatment.(Effect on swallowing at 5 minutes and 2 h after the 1st application)