Status and phase
Conditions
Treatments
About
Name of study:
Randomized, Double-Blinded, Oseltamivir-and-Placebo-Controlled Clinical Study about Lingdancao Granules in the Treatment of Seasonal Influenza
Objective:
Preliminary evaluation on the efficacy and safety of Lingdancao granules in the treatment of seasonal influenza
Design:
Multicenter, randomized, double-blind, double parallel analogy, positive drug and placebo controlled trial
Case number:
This test is expected to be included in 318 cases of 14-65 (≥14 or ≤65) ages of subjects. Qualified participants are randomly divided into experimental drug group (Lingdancao granules group), positive control group (oseltamivir phosphate group) and placebo group, 106 cases in each.
Full description
Study Objectives This study wishes to evaluate the efficacy and safety of Lingdancao granules for the treatment of seasonal influenza (including seasonal influenza A/H1N1 and A/H3N2 type, the new influenza A (H1N1) or influenza B) and an economic analysis on drugs in an evidence-based clinical trial with Oseltamivir phosphate Capsules and placebo as contrast.
Design and Trial registration This clinical study is a multicentered, randomized, double-blind, double control trial that testes drugs and placebo. Non-inferiority (vs. positive control) and superiority (vs. placebo control) trials are conducted.
After clinical ethics approval and before the participants' randomly enrolment, the research plan is registered both in clinicaltrials.gov and in the center of Chinese clinical trial.
Study participants
1 Designed case number of participants The study is designed to enroll 360 411 cases of patients (male and female) suffering seasonal influenza (including seasonal influenza type A/H1N1 and A/H3N2, the new influenza A (H1N1) or influenza B) aged 14-65 years.
Recommendations from the World Health Organization (WHO) for influenza-like illnesses (ILIs) are used as the basis for influenza surveillance. If a patient presents with an acute cough and fever, clinicians must be highly vigilant to test for infections caused by the influenza virus. In general, the rate of ILI cases that lead to a clinical diagnosis of influenza infection is about 18-80%, which is higher than other clinical diagnoses, e.g. acute infections of the upper respiratory tract. Therefore adult ILI patients are selected for inclusion in the study.
Treatment
Drugs 1.1 Drugs for experimental group Lingdancao granules (3g/pack, license number XXXXX, produced by Panlongyunhai Co., Ltd.) 1.2 Drugs for control group Oseltamivir phosphate capsule (tamiflu) (License number J20090076, produced by Shanghai Lou's Pharmaceutical Co., Ltd.) 1.3 Analogous drugs Analogous Lingdancao granules (license number XXXX) Analogous oseltamivir phosphate capsule (license number XXXX) All drugs are packaged by the Panlongyunhai Co., Ltd. according to the requirements of a double-blind, double-simulation test.
Dosage and specifications 2.1 Study drugs Lingdancao granules, electuary (IIR, 3g/pack, license number XXXXX, produced by Panlongyunhai Co., Ltd.) Oseltamivir phosphate capsule (tamiflu) (98.5mg/capsule, equals to 75mg oseltamivir, license number J20090076) Placebo, analogous Lingdancao granules, analogous oseltamivir phosphate capsule (specifications as above, produced by Panlongyunhai Co., Ltd.) Randomly numbered ①②③, prescribed by doctors according to the selected time sequence of the patients 2.2 Package and label All drugs are packaged by the Panlongyunhai Co., Ltd. according to the requirements of a double-blind, double-simulation test, in order to avoid patients to differentiate the three. All drugs will be packed by randomly number①②③ with 5 days dosage. Each pack has 2 parts of viscous labels, including parts for peeling off. Drug labels will be printed in Chinese, including following contents.
2.4 Blinded study and evaluating time This study is a randomized blinded parallel controlled clinical trial, designed by statistical professionals using computer simulation for random scheme. The preparation of blind coding and treatment code is completed according to regulations, and corresponding report of blind coding record is completed and preserved in duplicate, respectively at the sponsor and clinical trials group units.
Subjects through screening are entered into the stage of blinded study when drugs are dispending according to the random number sequence by a researcher at the specified, Researchers participating in symptom evaluation have no knowledge of the kind of study drugs.
Usage and dosage Dosing based on instructions of Lingdancao particles and Oseltamivir phosphate capsules (tamiflu).
3.1 Drugs for experimental group Lingdancao granules, 34 packs per time (3g/pack), three times per day; analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day 3.2 Drugs for positive control group Oseltamivir phosphate capsule (tamiflu), 1 capsule per time (75mg), twice per day; analogous Lingdancao granules, 34 packs per time, three times per day 3.3 Drugs for placebo control group Analogous Lingdancao granules, 4 packs per time, three times per day Analogous Lingdancao granules, 3 packs per time, three times per day, analogous oseltamivir phosphate capsule, 1 capsule per time, twice per day 4 Course of treatment Drugs must be used on the day of fever and last for five days continuously. In addition, in view of the contagiousness of virus, take 2 days after prior symptoms disappear as the boundary, is possible to continue medical treatment after the participants' symptoms disappear.
Participators who meet the inclusion criteria are given by the study drugs according to the random number on the day when they are included into the study. And the first day using drugs is defined as the first day of the study, while the second day begins from 24:00 the same day. According to the time of the first medication, the last time for using drug will be on the 5th or 6th day. If the first medication is after 17:00 on the first day, the next meditation will be on the following morning. In this case, the last medication will be on the morning of the 6th day. If the first medication is before 17:00 on the first day, the next administration will be on the same day at night (before midnight). In this case, the last time to give medicine will be in the evening on the 5th day.
5 Other treatment Once other drugs are taken because of inevitable condition, or dosage is changed, the name of drug, reason for using, methods, dose and time of using must recorded on the case table.
5.1 Standard of drug using Body temperature≥38.5℃, cannot be lower after 4 hours' physical cooling, or body temperature gradually raised up to more than 39℃; or headache, muscle pain symptom scores 3 points or more.
5.2 Symptomatic drugs (provided by the Panlongyunhai Company) 5.2.1 Fever, acetaminophen. 5.2.2 Cough with white phlegm, brombexine hydrochloride. 5.2.3 Mild asthma, long-term theophylline. Apart from the drug above, no other drugs can be used. 6 Criteria for free additional auxiliary examination 6.1 In case of worsening cough, phlegm, bloody sputum, chest pain or fast breathing rate, dyspnea, routine blood test, chest X-ray examination are given; 6.2 In case of gastrointestinal symptoms such as vomiting, diarrhea, routine blood test, liver function, renal function, blood electrolyte are given; 6.3 In case of heart palpitation, chest suppression, chest pain and syncope, electrocardiogram (ECG) and myocardial enzyme are given.
7 Compliance Researchers or co-researchers will guide participants record the actual dose of drugs in their diary. According to the diary, researchers or co-researchers will evaluate compliance of the participant on the basis of the following four grades in different stages and record it in the case report after each follow-up.
7.1 Take medications according to rules. 7.2 Take medications mostly according to rules, (80%-120% of the designed dose) 7.3 Take medications half of the time according to rules. 7.4 Almost with no medication (no more than half the time) Once the subject is not taking drugs according to stipulations, reasons must be indicated.
Because of the particularity of influenza, doctors can keep the subjects hospitalized until the fever is retreated according to specific conditions.
Study design 1 General design and arrangement This study will follow design of randomized, blinded, positive drug and placebo controlled together with parallel group; subjects are screened from seasonal influenza virus infected patients.
300 411patients conforms to the inclusion and exclusion criteria and signed informed consent are participating in this study, and are randomly assigned to Lingdancao granules group, Oseltamivir phosphate capsules (Tamiflu) group, and placebo group.
2 Specific processes Follow-up Visit 1 0 Screening and baseline Before the start of the trial, patients should be fully obtain written and verbal descriptions about the study, and signed a written informed consent.
Record
Demographic information
Physical examination
Laboratory tests
Laboratory tests given before follow-up1 up0 are used for screening subjects into the research, as well as a baseline of other laboratory tests.
Follow-ups 21-5 3 are treatment period. Each of the follow-up should include the following.
Follow-up7 up 4 or premature termination need to carriy out the following.
Study medications, other drugs and basic treatment should be given by the doctors or taken according to the doctor's guidance; participants will receive a written guidance about the daily usage of the drugs.
Participants should report daily to researchers about the number of pills taken. In addition, the researchers need to count the number of pills in the opened drug boxes, and the number of unpacking boxes. After the test, all the rest of the study drug or placebo must be returned to the clinical arbitrator together with boxes.
3.2 Principles and standards of suspending After starting taking study drug, once any of the following circumstances appear, the researchers or co-researchers must stop the treatment of patients and take corresponding measures immediately.
3.3 Shedding and missing follow-ups After the beginning of the study's medication, once the subjects drop out the study due to any of the following reasons, the researchers or co-researchers must take the appropriate measures and investigate the result of the subjects.
3.4 Principles and standards for comprehensive stopping of the study
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
1.2 Confirmed infection by the influenza A or B virus or the new influenza A (H1N1) virus according to virological examination.
1.3 Acute onset within 72 hours. 1.4 Axillary temperature ≥38℃, with at least two of the following symptoms, headache, body discomfort, muscle pain, aversion to cold or cold chills, fatigue; along with either one of the respiratory symptoms from cough, sore throat and nasal symptoms.
1.5 Voluntarily signed informed consents
Exclusion criteria
2.3 Routine blood test when screening displayed WBC>10.0x109/L, or NEUT. ≥75%. 2.4 Patients coughing purulent sputum or with suppurative tonsillitis. 2.5 Patients with diabetes or serious underlying disease, such as blood disease, severe COPD (FEV1 / EVC < 70%, FEV1 of expected value < 50%; or respiratory failure or right heart failure), severe hepatic insufficiency (ALT or AST 3 times above normal or higher); severe renal insufficiency (serum creatinine > 2 mg/dL); chronic congestive heart failure (NYHA heart function level Ⅲ- IV), psychiatric diseases.
2.6 Have already taken antiviral drugs (amantadine, rimantadine, zanamivir and oseltamivir phosphate, etc.) or related Chinese medicine or Chinese patent medicine after the onset before the screening. Or patients have taken Choulingdan or Chinese patent medicine with Choulingdan as part of the ingredients within 1 week before the onset.
2.7 Allergic to Choulingdan or its preparations composition, to oseltamivir or its ingredients, and to drug simulation ingredients, or allergic constitution.
2.8 Women in pregnancy or lactation period, women of childbearing age with plan of a pregnancy.
2.9 Patients with immune deficiency, such as malignant tumor, organ or bone marrow transplantation and AIDS, or taking immunosuppressant in 3 months.
2.10 With dubious or confirmed alcohol and drug abuse history. 2.11 Patients that have been in a similar drug clinical study in 3 months. 2.12 Suffered from acute respiratory infection, otitis media or sinusitis 2 weeks before.
2.13 Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 mouths before.
2.14 Other reasons that researchers think not fitting to participate in the study.
Primary purpose
Allocation
Interventional model
Masking
318 participants in 3 patient groups, including a placebo group
Loading...
Central trial contact
Xinhua Wang, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal