The efficacy and safety of Andrographis paniculata extract for the treatment of acute nonspecific upper respiratory tract infections: a randomized double-blind placebo controlled trial

Phase 3

Completed

• Conditions: Acute nonspecific upper respiratory tract infections with one or more symptoms such as fever, sore throat, nasal congestion, Andrographis paniculata; dry infrequent cough and had modified Centor Score of 2 or less.; andrographolide; acute nonspecific upper respiratory tract infections; common cold; pharyngitis

• Registration Number: TCTR20170329002
• Lead Sponsor: Department of Thai Traditional and Alternative Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-29
• Study Completion: 2019-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 829

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified