Efficacy and safety of Andrographis paniculata extract for the treatment of asymptomatic or mild-symptoms COVID-19 patients: A double-blinded, randomized-control trial

Phase 3

Recruiting

• Conditions: COVID-19 patienrs, RT-PCR confirmed; Covid-19 treatment; Andrographidis paniculatae extract; Pneumonia

• Registration Number: TCTR20211224002
• Lead Sponsor: Health System Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-24
• Study Completion: 2022-09-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 736

Inclusion Criteria

1. Male or female aged 18-60 yrs.
2. Confirmed COVID-19 infection with RT-PCR within 72 hrs.
3. No clinical or mild symptoms with WHO clinical progression scale not more than 2 and Oxygen saturation more than 96% and no desaturation after performed a minute of Sit-to-stand test and chest x-ray does not illustrated evidence of pneumonia which confirmed by at least 2 of three chest-internal medicine specialized physician or radiologist doctor.
4. Respiratory rate not over than 20 times per min.
5. No underlying or uncontrollable underlying disease during last 6 months.
6. Agree to participate in this trial.

Exclusion Criteria

1. Has history of Andrographis paniculata extract or capsules.
2. Has clinical severity more than two of WHO clinical progression scale
3. Has history of taking one to more of chloroquine, hydroxychloroquine, ivermectin, interferon or antibiotics during the last seven days
4. Has history of taking any herbs or Andrographis paniculata extract or capsules unless the taking dose is less than 30 percent of our recommend doses or 60 mg/day
5. Has history of taking at least one or more of corticosteroid drugs, chemotherapy drugs or radiotherapy during the last 6 months.
6. Has history of taking Clopidogrel,warfarin, statins, amlodiprine, clozapine, and Phenytoin.
7. Pregnant or breast-feeding woman.
8. High risk groups
8.1 BMI equal or more than 30 kg/m2
8.2 COPD
8.3 CKD stage 3 and up
8.4 Cardiovascular disease
8.5 Stroke
8.6 Uncontrolled diabetes mellitus
8.7 Cirrhosis or hepatitis which AST or ALT elevated more than 3 times of ULN.
8.8 Lymphocyte is less than 1,000 Cell/mm3)
8.9 Cancer patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of COVID-19 pneumonia 10 Days Chest x-ray

Secondary Outcome Measures

Name	Time	Method
time-to-event of SaO2 10 Days Pulse oximeter,COVID-19 Viral load 0,5,10 Days RT-ddPCR,SARS-CoV-2 Detection 0,10 Days cycle time of RT-PCR,Side effect of andrographis paniculata 1-14 Days Common Terminology Criteria for Adverse Event (CTCAE) version 5.0