To determine the safety and efficacy of MUCOADHESIVE TABLETS for patients with inflammation of sore throat.
- Conditions
- Health Condition 1: J39- Other diseases of upper respiratory tract
- Registration Number
- CTRI/2021/10/037205
- Lead Sponsor
- Rajalakshmi Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult patients with acute sore throat above 18 years
2. >4 points on a visual analog scale (VAS).
3. >75 mm on Sore Throat Pain Intensity Scale (STPIS).
4.Patients should have sore throat within 4 days
5.Willing to comply with all requirements of this study protocol as well as instructed by the study personnel.
6.Patients who agree not to use any other medication for the sore throat during the study period.
7.No clinically significant abnormal finding on Medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems).
1.Patient had been sore throat for more than 4 days
2.Evidence of mouth breathing or severe coughing, existence of other distracting pain.
3.Patients were also excluded if they had used any sore throat medication containing a local anaesthetic within the previous 4 hours.
4.Analgesic, antipyretic, or cold medication (such as decongestant, antihistamine, antitussiveor throat lozenge/spray) within the previous 8 hours.
5.A longer acting or slow-release analgesicduring the previous 24 hours (for examplepiroxicam, naproxen).
6.Any medicated confectionary, throat pastille, spray, or any product with demulcent properties (such as boiled sweets) in the previous 2 hours or antibiotics inthe previous 14 days.
7.The patient with Oral lesion suspected to be malignant
8.If the patient has undergone any experimental oral intervention within the last 24 hours.
9.History of alcohol addiction or abuse.
10.Patient who had participated in any other study within the 90 days of study
11.Patient who are not willing to enter the dosing details in their diary.
12.Females likely to become pregnant during conducting of the study
13.Pregnant and Lactating females.
14.Consumption of tobacco containing products Tobacco and tobacco products (like Khutkha, Pan/ Pan Masala, Beedi, Cigarettes) for at least 24.00 hours prior to screening and throughout the entire study
15.Consumption of vaping products
16.Any major illness in the last 03 months or any significant ongoing chronic medical illness.
17.Evidence of allergy or known hypersensitivity to Muco-Adhesive tablets, Strpesils and its components.
18.History of dehydration from diarrhea, vomiting or any other reason within a period of 48.00 hours prior to study check-in of each visit.
19.Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion
20.Patients with Malignancy or a history of malignancy
21.Patients with Positive results for HIV or Hepatitis B or C
22.Immunocompromised patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 01 before the treatment and on Day 03 and Day 08.Timepoint: 1. Pain intensity reduction using a Pain intensity Scale through VAS (Visual Analogue Scale) on Day 01 before the treatment and on Day 03 and Day 08.
- Secondary Outcome Measures
Name Time Method /APTimepoint: N/AP