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A Clinical Trial of KT07 Capsule in the U.S.A

This study is currently recruiting participants.
Verified November 2016 by Yiling Pharmaceutical Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02867358
First Posted: August 15, 2016
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yiling Pharmaceutical Inc.
  Purpose
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.

Condition Intervention Phase
Influenza, Human Drug: KT07 Capsule Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza

Resource links provided by NLM:


Further study details as provided by Yiling Pharmaceutical Inc.:

Primary Outcome Measures:
  • Changes of the duration of illness compared to placebo [ Time Frame: Up to 19 days ]

Secondary Outcome Measures:
  • The percentage of subjects experience complications [ Time Frame: Up to 19 days ]
  • The percentage of subjects experienced alleviation of influenza symptoms at every 24 hours [ Time Frame: Up to 19 days ]

Other Outcome Measures:
  • Duration of viral shedding [ Time Frame: At day 3 and day 6 ]

Estimated Enrollment: 420
Study Start Date: September 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose of KT07 capsule
It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen Capsule
Active Comparator: Low dose of 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).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen Capsule
Other: Placebo
Placebo Comparator: Placebo
It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.
Other: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects with mild or moderate acute uncomplicated influenza, and oral temperature of 37.3-39.3℃ (99.1-102.8° F); plus at least one respiratory symptoms (nasal congestion, sore throat or cough); and at least one constitutional symptoms (aches and pains, fatigue, headache and chills or sweats).
  2. Subjects who have recently been exposed to patients infected with influenza virus with or without rapid influenza diagnostic test (RIDT) confirmed influenza infection (influenza virus A or B infection).
  3. Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug administration visit) and receiving no antiviral/anti-influenza medication.
  4. Age 18 to 50 years old.
  5. Subjects who are able to understand and are willing to sign the informed consent form (ICF).
  6. All female subjects must have a negative urine pregnancy test result . All female subjects and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days for female and 90 days for male subjects after study drug discontinuation.

Exclusion Criteria:

  1. Subjects who suffer from severe influenza with oral temperature of more than 39.3℃ (102.8°F) with or without other symptoms.
  2. Subjects who have any of following documented conditions: lower respiratory tract infection other than influenza, asthma requiring daily therapy, including acute flare of chronic asthma and bronchial asthma, chronic obstructive pulmonary disease (COPD), acute infectious disease, any other chronic respiratory disease, bacterial infection of respiratory system, such as: suppurative tonsillitis, acute tracheobronchitis, sinusitis, otitis; subjects with history of moderate to severe cardiac, hepatic, renal and hematopoietic disorders, bleeding tendency or hemorrhagic disease,mental and neurological system disease; subjects with hypertension, diabetes, hyperthyroidism and increased intraocular pressure; and subjects with cancer.
  3. Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
  4. Subjects who have to take other medications for the treatment of influenza or related symptoms, including but not limited to antipyretic and analgesic medicines, antibiotics, and antiviral drugs.
  5. Subjects with acute dyspnea, wheezing, moist rales on screening examination.
  6. Clinically very excessively obese subjects with BMI≥40.
  7. Alcoholism or substance abuse history.
  8. Subjects received influenza vaccine within 6 months.
  9. Participation in other clinical trial within 1 month.
  10. Pregnant or breast-feeding females subjects
  11. Allergy or known allergy to components of study medication.
  12. Allergy to aspirin or non-steroid anti-inflammatory drugs (NSAIDs), such as ibuprofen.
  13. Subjects received antipyretic and/or analgesic medications for conditions other than influenza such as back pain prior to randomization.
  14. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, antiviral and antibacterial drugs during last 4 weeks before the first dose.
  15. Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede participation in the study or affect the study results.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867358


Contacts
Contact: Anni Li, Pharm D 240-421-2794 lanni122508@gmail.com

Locations
United States, California
Hope Clinical Research, Inc. Recruiting
Canoga Park, California, United States, 91303
Contact: Hessam Aazami, MD    818-999-4673    haazami@hopeclinical.com   
Core Health Care Group Recruiting
Cerritos, California, United States, 90703
Contact: Francisco L. Badar III, MD    562-924-8880    fbadarmdinc@gmail.com   
Lalla-Reddy Medical Corp. Recruiting
Fountain Valley, California, United States, 92708
Contact: Sujata Lalla-Reddy, MD    714-968-6789    DrReddy@suereddymd.com   
Downtown L.A. Research Center, Inc. Recruiting
Los Angeles, California, United States, 90017
Contact: Salil U. Nadkarni, DO    213-261-3680    snadkarni@dtlaresearch.com   
IMD Medical Group Recruiting
Los Angeles, California, United States, 90020
Contact: Imad A. El Asmar, MD    213-487-6889    imadelasmar@imdmedicalgroup.com   
Facey Medical Foundation Not yet recruiting
Mission Hills, California, United States, 91345
Contact: Riga Pemba, MD    818-869-7067    rpemba@facey.com   
Empire Clinical Research Not yet recruiting
Upland, California, United States, 91786
Contact: Yogesh K. Paliwal, MD    909-981-5321    apaliwal@empirereserach.com   
United States, Connecticut
Clinical Research Consulting Recruiting
Milford, Connecticut, United States, 06460
Contact: Susann Varano, MD    203-386-3115    svarano@clinicalrc.com   
Comprehensive Psychiatric Center Recruiting
Norwich, Connecticut, United States, 06360
Contact: Kartik Viswanathan, MD    860-886-1508    kartik.renuka@gmail.com   
United States, Florida
Sweet Hope Research Specialty, Inc Recruiting
Miami Lakes, Florida, United States, 33016
Contact: Raul Ebran-Gonzalez, MD    305-456-9062    r.gonzalez@sweethoperesearch.com   
Finlay Medical Research Corp. Recruiting
Miami, Florida, United States, 33126
Contact: Lilia Rodriguez Ables, MD    305-459-3578    LRAbles@finlaymedicalresearch.com   
Panamerican Health Center, Inc. Recruiting
Miami, Florida, United States, 33126
Contact: Luis M. Ramos Gonez, MD    305-567-0060    lramosresearchmd@gmail.com   
AppleMed Reseach, Inc. Recruiting
Miami, Florida, United States, 33155
Contact: Augustin J. Latorre, MD    305-667-8434    Dr.latorre@applemedresearch.org   
Sunrise Medical Research Recruiting
Tamarac, Florida, United States, 33351
Contact: Jason M Haffizulla, MD    954-915-9991    jhaffizulla@sunrisemedresearch.com   
Sunrise Medical Research Recruiting
West Palm Beach, Florida, United States, 33406
Contact: Rafael Nunez-Avila, MD    305-477-6750    Oavilaresearch@gmail.com   
Southeast Clinical Research Recruiting
Williston, Florida, United States, 32696
Contact: Anubha Gupta, MD    352-490-4816    secr2gupta@gmail.com   
United States, New York
AccuMed Research Associates Recruiting
Garden City, New York, United States, 11530
Contact: Mitchell Efros, MD    516-746-2190    Efrosdoc@aol.com   
New York Clinical Trials Recruiting
Manhattan, New York, United States, 10018
Contact: Mitchell Efros, MD    646-625-3011    researchdoc@nycclinicaltrials.com   
United States, Tennessee
Clinical Research Solutions, LLC Recruiting
Franklin, Tennessee, United States, 37067
Contact: Alex J. Slandzicki, MD    615-577-4017    drslandzicki@crssites.com   
Clinical Research Solutions, LLC Recruiting
Jackson, Tennessee, United States, 38305
Contact: Melanie Hoppers, MD    731-431-5027    drhoppers@crssites.com   
Clinical Research Solutions, LLC Recruiting
Nashville, Tennessee, United States, 37211
Contact: Heather Rowe, MD    615-415-3936    drrowe@crssites.com   
Clinical Research Solutions, LLC Recruiting
Smyrna, Tennessee, United States, 37167
Contact: Sadie Dar, MD    615-693-9742    drdar@crssites.com   
Clinical Research Solutions, LLC Recruiting
Spring Hill, Tennessee, United States, 37174
Contact: Rennee N. Dhillon, MD    615-577-4017    drdhillon@crssites.com   
United States, Utah
Wade Family Medicine Recruiting
Bountiful, Utah, United States, 84010
Contact: Ralph D. Wade, DO    801-292-2850    rwade@progressiveclinicalresearch.com   
J. Lewis Research, Inc./ Foothill Family Clinic Draper Recruiting
Draper, Utah, United States, 84020
Contact: Stephen D. Coleman, MD    385-900-4077    scoleman@jlewisresearch.com   
J. Lewis Research, Inc. / Foothill Family Clinic Recruiting
Salt Lake City, Utah, United States, 84109
Contact: James Todd Peterson, MD    801-486-3021 ext 3370    jpeterson@jlewisresearch.com   
J. Lewis Research, Inc. / Foothill Family Clinic South Recruiting
Salt Lake City, Utah, United States, 84121
Contact: Shane Christensen, MD    801-365-1032 ext 3506    schristensen@jlewisresearch.com   
J. Lewis Research, Inc./ FirstMed East Recruiting
Salt Lake City, Utah, United States, 84121
Contact: Stephanie Plunkett, MD    801-733-4057    splunkett@jlewisresearch.com   
CopperView Medical Center Recruiting
South Jordan, Utah, United States, 84095
Contact: Mary D. Tipton, MD    801-294-9911    tipton@rx-research.com   
Sponsors and Collaborators
Yiling Pharmaceutical Inc.
Investigators
Study Chair: Xuedong Gao, MD Yiling Pharmaceutical Inc.
  More Information

Responsible Party: Yiling Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02867358     History of Changes
Other Study ID Numbers: KT07-US-01
First Submitted: August 10, 2016
First Posted: August 15, 2016
Last Update Posted: July 2, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yiling Pharmaceutical Inc.:
acute uncomplicated influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases