TABLE 6.
Herbal preparations of Andrographis paniculata used in RCTs, non-RCTs, case series and their ADRs/AEs.
| Preparations | Form | Active ingredients | Study ID | Country | Dosage | Duration | ADR/AE incidence | Number of ADRs/AEs with CTCAE grading | Total number of ADRs/AEs | Detailed description | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G1 | G2 | G3 | G4 | G5 | Unclear | ||||||||||
| Andrographis Paniculata dry powder capsule | Capsule | dry powder of the aerial part of Andrographis Paniculata | Agarwal et al. (2005) | Malaysia | start with 600 mg daily, gradually increase to a maximum of 1.8 mg daily | 12 weeks | 5.00% (1/20) | 1 | 0 | 0 | 0 | 0 | 0 | 1 | nausea 1 |
| KalmCold | Capsule | extract from the leaves of Andrographis Paniculata Nees | Saxena et al. (2010) | India | 200 mg/day | 5 days | 5.36% (6/112) | 7 | 1 | 0 | 0 | 0 | 0 | 8 | diarrhea 3, vomiting 1, epistaxis 1, urticaria 1, nausea 1, lethargy 1 |
| ApE tablet | Tablet | Andrographis Paniculata purified extract | Bertoglio et al. (2016) | Chile | 1 tablet/time, twice daily | 12 months | 7.69% (1/13) | 1 | 0 | 0 | 0 | 0 | 0 | 1 | skin rash 1 |
| Chuanxinlian tablets | Tablet | Andrographis Paniculata | Li and Yang, (2016) | China | 2–3 tablets/time, 3–4 times/day | 7–14 days | 3.50% (7/200) | 0 | 0 | 0 | 0 | 0 | 7 | 7 | rash 3, digestive symptoms 2, dizziness 1, fever 1 |
| Standardized Andrographis Paniculata capsule | Capsule | Andrographis Paniculata crude powder | Suriyo et al. (2017) a | Thailand | 4 capsules/time, 3 times/day | 3 days | — | 24 | 2 | 0 | 0 | 0 | 4 | 30 | thirst 8, dysgeusia 2, abdominal swelling 3, skin or eyes turn yellow 3, itchiness 1, abdominal pain 2, fever 1, dizziness 1, nausea 1, shiver 1, loss of weight 3, fatigue 4 |
| FANG(30) | Tablet | dried extract of Andrographis paniculata | Burgos et al. (2009) | Chile | 1 tablet/time, 3 times/day | 14 weeks | 36.67% (11/30) | 0 | 0 | 0 | 0 | 0 | 11 | 11 | headache 3, diarrhea 1, nausea 2, stomach discomfort 1, fatigue 1, common cold 1, pruritus/rash 1, cramps 1 |
| ParActin | Capsule | Andrographis paniculata purified extract | Hancke et al. (2019) | India | 300 mg/day | 12 weeks | 21.62% (8/37) | 0 | 0 | 0 | 0 | 0 | 9 | 9 | acidity 4, elevated alanine aminotrasferase 2, constipation 1, oral ulcers 1 |
| 600 mg/day | 2.86% (1/35) | elevated alanine aminotrasferase 1 | |||||||||||||
| HMPL-004 | Capsule | Andrographis Paniculata ethanol extract | Tang et al. (2011) | China | 1200 mg/day | 8 weeks | 13.21% (7/53) | 0 | 0 | 0 | 0 | 0 | 9 | 9 | aphthous ulcer 1, white blood cell decrease 1, abdominal pain 1, blood in stool 1, fever 1, elevated glucose 1, rash 1, blood in urine 1, elevated C-reactive protein 1 |
| Sandborn et al. (2013) | the United States, Canada, Germany, Romania, Ukraine | 1200 mg/day | 8 weeks | 60.00% (45/75) | 5 | 1 | 0 | 0 | 0 | 78 | 84 | headache 8, abdominal pain 4, nausea 4, diarrhea 3, dyspepsia 3, ageusia 3, alanine aminotransferase increased 3, blood alkaline phosphatase increased 3, gamma-glutamyl transferase increased 3, rash 3, influenza 2, nasopharyngitis 2, fatigue 2, flatulence 1 | |||
| 1800 mg/day | 52.00% (39/75) | abdominal pain 4, diarrhea 4, flatulence 4, headache 4, nausea 3, dysgeusia 3, blood glucose increased 3, rash 3, back pain 3, ageusia 2, influenza 2, nasopharyngitis 2, dyspepsia 1, gamma-glutamyl transferase increased 1, anemia 1 | |||||||||||||
| Andrographis paniculata extract (APE) capsule | Capsule | Andrographis paniculata extract | Phunikhom et al. (2015) | Thailand | 3 capsules/day | 8 weeks | 10.00% (2/20) | 5 | 0 | 0 | 0 | 0 | 0 | 5 | nausea 2 |
| 5 capsules/day | 15.00% (3/20) | nausea 3 | |||||||||||||
a
In this study, only the number of AEs was reported, but the number of patients experiencing AEs was not reported. Therefore, the incidence of AEs could not be obtained.