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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211224002
Enrollment
736
Registered
2021-12-24
Start date
2021-12-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 patienrs, RT-PCR confirmed Covid-19 treatment Andrographidis paniculatae extract Pneumonia

Interventions

Andrographis Paniculata Extract 60 mg./capsu
es,Lactose with microcrystalline cellulose
Experimental Drug,Placebo Comparator Dietary Supplement

Sponsors

Health System Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Incidence of COVID-19 pneumonia 10 Days Chest x-ray

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactChavanvalai Meksawasdichai

Saraburi provincial health office

pattaranan_p@hotmail.com0805934084

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026