Acute nonspecific upper respiratory tract infections with one or more symptoms such as fever,
Conditions
Interventions
Patients will receive a physical and laboratory examination
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Treatment
1. Patients will receive Andrographis paniculata extract capsule (andrographolide ≥ 20 mg/cap). Take 1 capsule aftermeal 3 times a day (breakfast,
lunch and dinner) for four days
a total of 12 capsules.
2. Patients will receive paracetamol tablet (paracetamol 500 mg/tab) for symptom relief if needed and record the tablet taken.
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Patients will receive self-
assessment forms (Case report form for patiens). To record daily symptoms from 1-
3 days,
the onset of symptoms assessment on Day 1 was described.
Day 2
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assessment with VAS and record in case report form for patients
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Patients record adverse reactions and time. (if symptoms occur)
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Patients recorded use of paracetamol. (if use)
Day 4-
7
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The patient returns to the doctor for evaluation of treatment.
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Investigators collected case report form from the patients.
Day 7 and Day 14-
30
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Investigators telephone for second follow-
up and interview the satisfactory of the assigned drug and the safety. the patient may return to the clinic in stead of telephone if they wanted to ,the protocol used in the first arm was used similar
Experimental Drug,Placebo Comparator Drug
Day 1
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Sponsors
Department of Thai Traditional and Alternative Medicine
the Medical Association of Thailand under the royal patronage
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Adults aged 18 to 60 years old who attended the OPD clinics within 72 hours after the onset of URI symptoms and were diagnosed as acute NS-URI which had one or more symptoms such as fever, sore throat, nasal congestion, dry infrequent cough and had modified Centor Score of 2 or less. The patients could take the assigned medication and returned for the first follow up at days 4-7. They would be able to receive phone call for interviewing the illness and symptoms in the second follow-up at days 14-30 and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients who have been diagnosed is an upper respiratory tract caused by bacterial infection. 1) High fever. (>38.3 °C) 2) Pustules found on the tonsils. 3) Lymph nodes in the neck> 1 cm or feeling sore from the neck at one side by palpation. 2.There is evidence that severe upper respiratory infections such as acute sinusitis, allergic rhinitis, influenza. 3.Shortness of breath / difficulty, difficulty speaking. 4.Has nausea, vomiting, diarrhea, hemorrhage or other severe symptoms. 5.Modified Centor score> 2. (Please specify ............) ุ6.Has a history of rheumatic heart disease or nephritis, because it was attached Streptococcus group A. 7.Has a history of allergic Andrographis paniculata extract. 8.Have chronic liver or kidney disease from history of treatment and / or blood test results. 9. Pregnant or breastfeeding women. 10.Blood clotting medication is used. (Clopidogrel, warfarin, aspirin) 11.Within 48 hours after the onset of symptoms before seeing a doctor. Patient records that. Get antibiotics like amoxicillin, antibiotics, steroids or steroids, NSAIDs or other herbs. 12.The recipient immunosuppressant agents or chemotherapy. 13.The recipient organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapeutic efficacy of Andrographis paniculata extract in acute NS-URI Day1 And Days 4-7 Visual Analog Scale (VAS) by the patient,Rescue medicine for symptom relief in URI day1 to day4 number of paracetamol used in each arm,patient satisfaction of the assigned treatment day 7-14 interview | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Andrographis paniculata extract treatment of acute non specific upper respiratory Day7 and Day 14-30 Adverse event; AEs | — |
Contacts
Public ContactMonthaka Teerachaisakul
Director of Thai Traditional Medicine Research Institute
Outcome results
None listed