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)
Central Alabama Research
🇺🇸Birmingham, Alabama, United States
Parkway Medical Center, LLC
🇺🇸Birmingham, Alabama, United States
Cahaba Research, Inc.
🇺🇸Birmingham, Alabama, United States
David Wever
🇺🇸Pelham, Alabama, United States
Alliane Urgent Care
🇺🇸Tolleson, Arizona, United States
Orange County Research Institute
🇺🇸Anaheim, California, United States
Hope Clinical Research, Inc.
🇺🇸Canoga Park, California, United States
Core Health Care Group
🇺🇸Cerritos, California, United States
Aviva Research
🇺🇸Escondido, California, United States
Lalla-Reddy Medical Corp.
🇺🇸Fountain Valley, California, United States
Scroll for more (64 remaining)Central Alabama Research🇺🇸Birmingham, Alabama, United States