The Efficacy and Safety Study of Fuganlin Oral Liquid in Children With Influenza (Acute Upper Respiratory Infection)

NCT02622659 | Completed Phase 4 DMC

• 1 other identifier: 2012Pro170EKZY
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double blind, double dummy, positive drug parallel comparison, multi-centre clinical trial to assess the efficacy and safety of Fuganlin Oral Liquid in children with influenza (acute upper respiratory infection).

Conditions

Acute Upper Respiratory Infection

Keywords

acute upper respiratory infection

Outcome Measures

Primary Outcomes (1)

• The duration of cold symptoms

  Cold diagnostic criteria： 1. nasal congestion, runny nose, sneezing, itchy throat, or pain, cough 2. The chills, fever, no sweat or less sweat, headache, limb sour 3. The total number normal or low of white blood cells, neutropenia, relative increase in lymphocytes Cold cure criteria: 1. fever, aversion to wind individual symptoms disappeared 2. nasal congestion, runny nose, sore throat, cough individual symptoms disappeared

  Defined as the time from the onset of the cold to the time achieve a cold cure standard，time average 3 to 7 days

Study Arms (2)

Fuganlin Oral Liquid

EXPERIMENTAL

Fuganlin Oral Liquid:oral less than 1 years old: 5mL each time and three times a day 1\~3 years old: 10mL each time and three times a day 4\~6 years old: 10mL each time and four times a day 7\~12 years old: 10mL each time and five times a day Xiaoer Jiebiao Oral Liquid placebo:oral 1\~2 years old: 5mL each time and twice a day 3\~5 years old: 5mL each time and three times a day 6\~14 years old: 10mL each time and twice a day

Drug: Fuganlin Oral Liquid

Xiaoer Jiebiao Oral Liquid

ACTIVE COMPARATOR

Xiaoer Jiebiao Oral Liquid:oral 1\~2 years old: 5mL each time and twice a day 3\~5 years old: 5mL each time and three times a day 6\~14 years old: 10mL each time and twice a day Fuganlin Oral Liquid placebo:oral less than 1 years old: 5mL each time and three times a day 1\~3 years old: 10mL each time and three times a day 4\~6 years old: 10mL each time and four times a day 7\~12 years old: 10mL each time and five times a day

Drug: Xiaoer Jiebiao Oral Liquid

Interventions

Fuganlin Oral Liquid DRUG

less than 1 years old: 5mL each time and three times a day 1\~3 years old: 10mL each time and three times a day 4\~6 years old: 10mL each time and four times a day 7\~12 years old: 10mL each time and five times a day

Also known as: No other names

Fuganlin Oral Liquid

Xiaoer Jiebiao Oral Liquid DRUG

1\~2 years old: 5mL each time and twice a day 3\~5 years old: 5mL each time and three times a day 6\~14 years old: 10mL each time and twice a day

Also known as: No other names

Xiaoer Jiebiao Oral Liquid

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients diagnosed as acute upper respiratory infection.
• Patients with Traditional Chinese Medicine syndrome of qi deficiency and wind-heat.
• Patients aged 1 to 12 years.
• With course of disease in 48 hours or less.
• Signed informed consent by a Parent or legal guardians.

You may not qualify if:

• Patients diagnosed as tonsillitis, bronchitis, bronchiolitis, pneumonia;
• Patients have a history of hyperpyretic convulsion;
• Severe malnutrition, rickets patients and merge the heart, brain, liver, kidney and hematopoietic system and other serious primary diseases;
• The increased of serum creatinine (Cr), blood urea nitrogen (BUN), alanine aminotransferase (ALT), and urinary protein, urine RBC above "+", which can not use the test illness or possibly combined disease conditions to explain;
• Patients with allergic physique (Allergic to above two kinds of substance), allergic to the composition of the preparation or control drug;
• According to the doctors' determination,likely to loss to follow up.

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD: lead

Study Sites (1)

Luohe traditional Chinese medicine hospital

Luohe, Henan, 462000, China

Location

Study Officials

• Cao xia, MD

  Chongqing First People's Hospital

  PRINCIPAL INVESTIGATOR

• Yan yunying, MD

  Nanning maternal and Child Health Hospital

  PRINCIPAL INVESTIGATOR

• Hu suping, MD

  Nanchang City Hospital of integrated traditional Chinese and Western Medicine

  PRINCIPAL INVESTIGATOR

• Wang leping, MD

  Changzhou traditional Chinese medicine hospital

  PRINCIPAL INVESTIGATOR

• Liu Dexing, MD

  Liuzhou traditional Chinese medicine hospital

  PRINCIPAL INVESTIGATOR

• Qi Shihe, MD

  Xiangyang Central Hospital

  PRINCIPAL INVESTIGATOR

• Ding Lijun, MD

  Handan traditional Chinese medicine hospital

  PRINCIPAL INVESTIGATOR

• Yang Liping, MD

  Changzhi City People's Hospital

  PRINCIPAL INVESTIGATOR

• Feng Ziwei, MD

  Luohe traditional Chinese medicine hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: December 4, 2015
• Study Start: March 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 22, 2017

Record last verified: 2015-11

Locations

CN (1)