A Clinical Trial of KT07 Capsule in the U.S.A
- Conditions
- Influenza, Human
- Interventions
- Drug: KT07 CapsuleOther: Placebo
- Registration Number
- NCT02867358
- Lead Sponsor
- Yiling Pharmaceutical Inc.
- Brief Summary
The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 391
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High dose of KT07 capsule KT07 Capsule It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid). Placebo Placebo It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control. Low dose of KT07 capsule KT07 Capsule It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid). Low dose of KT07 capsule Placebo It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).
- Primary Outcome Measures
Name Time Method To investigate the improvement in reducing the duration of illness compared to placebo. Up to 19 days Duration of illness is defined as: the length of time to alleviation of all symptoms.
The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated.
- Secondary Outcome Measures
Name Time Method The reduction in duration of alleviation of individual symptom Up to 19 days From time zero to the time at which the symptom is less than or equal to mild and stable for at least 24 hours
Quality of life assessment Up to 19 days Based on the self-assessment questionnaire
Trial Locations
- Locations (74)
David Wever
🇺🇸Pelham, Alabama, United States
Core Health Care Group
🇺🇸Cerritos, California, United States
The Blackfoot Medical Center - Blackfoot
🇺🇸Blackfoot, Idaho, United States
Ardmore Family Practice
🇺🇸Winston-Salem, North Carolina, United States
Frontier Clinical Research, LLC
🇺🇸Smithfield, Pennsylvania, United States
Clinical Research Solutions, LLC
🇺🇸Spring Hill, Tennessee, United States
Pioneer Research Solutions
🇺🇸Beaumont, Texas, United States
Wade Family Medicine
🇺🇸Bountiful, Utah, United States
Bandera Family Health Clinic
🇺🇸San Antonio, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
CopperView Medical Center
🇺🇸South Jordan, Utah, United States
Clinical Research Partners
🇺🇸Richmond, Virginia, United States
Research Center of Fresno, Inc.
🇺🇸Fresno, California, United States
Finlay Medical Research Corp.
🇺🇸Miami, Florida, United States
Downtown L.A. Research Center, Inc.
🇺🇸Los Angeles, California, United States
MD Strategies Research Centers
🇺🇸San Diego, California, United States
Research Institute of South Florida, Inc.
🇺🇸Miami, Florida, United States
Sunrise Medical Research
🇺🇸West Palm Beach, Florida, United States
Hassman Research Institute
🇺🇸Berlin, New Jersey, United States
City Doc Urgent Care
🇺🇸Dallas, Texas, United States
Quaity Assurance Research Center
🇺🇸San Antonio, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc./ FirstMed East
🇺🇸Salt Lake City, Utah, United States
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Cahaba Research, Inc.
🇺🇸Birmingham, Alabama, United States
Cherry Creek Family Practice, PLLC
🇺🇸Denver, Colorado, United States
Urgent Care-Denver
🇺🇸Denver, Colorado, United States
Long Beach Clinical Trials Services, Inc
🇺🇸Long Beach, California, United States
Parkway Medical Center, LLC
🇺🇸Birmingham, Alabama, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Lalla-Reddy Medical Corp.
🇺🇸Fountain Valley, California, United States
Aviva Research
🇺🇸Escondido, California, United States
IMD Medical Group
🇺🇸Los Angeles, California, United States
MD Medical Research
🇺🇸Oxon Hill, Maryland, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Centex Studies, Inc
🇺🇸Lake Charles, Louisiana, United States
Empire Clinical Research
🇺🇸Upland, California, United States
Comprehensive Psychiatric Center
🇺🇸Norwich, Connecticut, United States
Doral Medical Research
🇺🇸Doral, Florida, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
MedPharmics, LLC
🇺🇸Metairie, Louisiana, United States
Horizon Research Group of Opelousas, LLC
🇺🇸Eunice, Louisiana, United States
New York Clinical Trials
🇺🇸Manhattan, New York, United States
Invocare (Savannah GA location)
🇺🇸Rincon, Georgia, United States
Buynak Clinical Research, P.C.
🇺🇸Valparaiso, Indiana, United States
META Medical Research Institute, LLC
🇺🇸Dayton, Ohio, United States
Red Rock Clinical Research, LLC
🇺🇸Las Vegas, Nevada, United States
Romedica LLC
🇺🇸Rochester, Michigan, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Carolina Research Center, Inc
🇺🇸Shelby, North Carolina, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc./ Foothill Family Clinic Draper
🇺🇸Draper, Utah, United States
American Family Care Urgent Care
🇺🇸Chattanooga, Tennessee, United States
Corpus Christi Family Wellness
🇺🇸Corpus Christi, Texas, United States
Centex Studies, Inc.
🇺🇸McAllen, Texas, United States
Premier Family Physicians
🇺🇸Austin, Texas, United States
Family Medicine Associates of Texas
🇺🇸Carrollton, Texas, United States
Medical Research International
🇺🇸Oklahoma City, Oklahoma, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Sweet Hope Research Specialty, Inc
🇺🇸Miami Lakes, Florida, United States
Panamerican Health Center, Inc.
🇺🇸Miami, Florida, United States
AppleMed Reseach, Inc.
🇺🇸Miami, Florida, United States
Florida Research Center, Inc.
🇺🇸Miami, Florida, United States
Southeast Clinical Research
🇺🇸Williston, Florida, United States
Infinite Clinical Trials
🇺🇸Riverdale, Georgia, United States
Village Health Partners
🇺🇸Plano, Texas, United States
Detweiler Family Medicine
🇺🇸Lansdale, Pennsylvania, United States
Northwest Med Care
🇺🇸Cypress, Texas, United States
Alliane Urgent Care
🇺🇸Tolleson, Arizona, United States
Mercury Street Medical Group, PLLC
🇺🇸Butte, Montana, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States