Is Andrographis paniculata extract and andrographolide anaphylactic?

Richard, Edwin Jothie; Murugan, Sasikumar; Bethapudi, Bharathi; Illuri, Ramanaiah; Mundkinajeddu, Deepak; Velusami, Chandrasekaran Chinampudur

doi:10.1016/j.toxrep.2017.07.004

Cited by 15 publications

(11 citation statements)

References 20 publications

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“…A. paniculata is the well-known medicinal plant, and the safety of using A. paniculata as a traditional medicine is supported by the results of the present study. Moreover, the report demonstrating that A. paniculata has no anaphylactic reaction which is a serious and potential deadly adverse effect [20] reinforces the safety of A. paniculata used. Based on a variety of pharmacological actions on A. paniculata , the possible application of standardized FTLEE of A. paniculata can be diverse including as an alternative or adjuvant treatment for cholangiocarcinoma and hepatocellular carcinoma.…”

Section: Resultsmentioning

confidence: 92%

Acute oral toxicity evaluation of Andrographis paniculata-standardized first true leaf ethanolic extract

et al. 2019

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Section: Resultsmentioning

confidence: 92%

Acute oral toxicity evaluation of Andrographis paniculata-standardized first true leaf ethanolic extract

et al. 2019

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“…Considering previous reports, mild-to moderate allergic reactions have been observed, especially with higher doses of andrographolide. In-vitro and in-vivo studies have shown that high-dose andrographolide induced histamine and LTC4 release in IgE sensitized RBL-2H3 cells, and release of tryptase, β-hexosaminidase and LTC4 tested through a non-IgE mediated pathway indicating it might induce anaphylactoid reactions [30]. Dysgeusia could be attributed to andrographolide bitterness [31].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial

et al. 2020

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Background: Multiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been reorganized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS. Methods: A pilot clinical trial using 140 mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change. Results: Forty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was − 0.679% for the AP group and − 1.069% for the placebo group (mean difference:-0.39; 95% CI [− 0.836-0.055], p = 0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200-1.777], p = 0.06). The mean EDSS change was − 0.025 in the AP group and + 0.352 in the placebo group (mean difference: 0.63, p = 0.042). Adverse events related to AP were mild rash and dysgeusia. Conclusions: AP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial. Trial registration: ClinicalTrials.gov NCT02273635 retrospectively registered on October 24th, 2014.

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Section: Discussionmentioning

confidence: 99%

Efficacy of andrographolide in not active Progressive Multiple Sclerosis: A prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial

Ciampi

Uribe-San-Martín

Cárcamo

et al. 2020

Preprint

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Background: Multiple sclerosis (MS) is a chronic immune mediated disease and the progressive phase appears to have significant neurodegenerative mechanisms. The classification of the course of progressive MS (PMS) has been re-organized into categories of active vs. not active inflammatory disease and the presence vs. absence of gradual disease progression. Clinical trial experience to date in PMS with anti-inflammatory medications has shown limited effect. Andrographolide is a new class of anti-inflammatory agent, that has been proposed as a potential drug for autoimmune disorders, including MS. In the present trial, we perform an exploratory pilot study on the efficacy and safety of andrographolide (AP) compared to placebo in not active PMS. Methods: A pilot clinical trial using 140mg oral AP or placebo twice daily for 24 months in patients with not active primary or secondary progressive MS was conducted. The primary efficacy endpoint was the mean percentage brain volume change (mPBVC). Secondary efficacy endpoints included 3-month confirmed disability progression (3-CDP) and mean EDSS change. Results: Forty-four patients were randomized: 23 were assigned to the AP group, and 21 were assigned to the placebo group. The median baseline EDSS of both groups was 6.0. Annualized mPBVC was -0.679% for the AP group and -1.069% for the placebo group (mean difference: -0.39; 95% CI [-0.836-0.055], p=0.08, relative reduction: 36.5%). In the AP group, 30% had 3-CDP compared to 41% in the placebo group (HR: 0.596; 95% CI [0.200 – 1.777], p=0.06). The mean EDSS change was -0.025 in the AP group and +0.352 in the placebo group (mean difference: 0.63, p=0.042). Adverse events related to AP were mild rash and dysgeusia. Conclusions: AP was well tolerated and showed a potential effect in reducing brain atrophy and disability progression, that need to be further evaluated in a larger clinical trial. Trial registration: ClinicalTrials.gov NCT02273635

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Is Andrographis paniculata extract and andrographolide anaphylactic?

Abstract: Graphical abstract

Cited by 15 publications

References 20 publications

Acute oral toxicity evaluation of Andrographis paniculata-standardized first true leaf ethanolic extract

Acute oral toxicity evaluation of Andrographis paniculata-standardized first true leaf ethanolic extract

Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial

Efficacy of andrographolide in not active Progressive Multiple Sclerosis: A prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial

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