Composition #1: Qi, J., Zhou, J.-H., Chen, L., Chen, J.-J., Yu, B.-Y., Qiu, S.-X. Study on chemical constituents in tuber of Harpagophytum procumbens D.C.. chinese pharmaceutical journal, 2006, vol. 41, no. 21, p. 1613–1615. .
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Plant part:
Roots and other underground parts (as part-nature) (A067M)
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Substance:
Triterpene saponins Triterpene saponins (RF-00004338-PAR)
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Analytical method code:
Standard Chromatographic tests (paper- thin layer- and column chromatography) (F016A)
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Yes/No Qualitative:
Positive/Present (POS)
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Result type:
Qualitative Value (Binary) (BIN)
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Internal remarks:
Triterpenoid saponins
Endpoint study
#1: Vlachojannis J., Roufogalis B D., Chrubasik S. Systematic review on the safety of Harpagophytum preparations for osteoarthritic and low back pain. phytotherapy research : ptr, 2008, p. 149–152. .
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Study relevance:
Human health
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Plant part:
Unspecified (A07XD)
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Type of toxicological test:
acute toxicity (CHD016TT)
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Route of exposure:
ORAL: UNSPECIFIED (OECD2234PL)
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Control groups used:
no data
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Endpoint measured:
Dose not reported (CHD066EP)
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Critical effect:
Digestive (TOX18A)
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Target tissue:
Digestive (TT002A)
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Effect description:
Potential side effects of Harpagophytum include gastrointestinal upset, low blood pressure, or abnormal heart rhythms (increased heart rate or increased heart squeezing effects (www.nlm.nih.gov/medlineplus/druginfo/natural/patient-devilsclaw.html#Safety).
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Effect or parameter linked to the endpoint:
other (CHD003BE)
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Internal remarks:
Potential side effects of Harpagophytum include gastrointestinal upset, low blood pressure, or abnormal heart rhythms (increased heart rate or increased heart squeezing effects.
Endpoint study
#2: [Anonymous]. Devil's claw root: ulcers and gastrointestinal bleeding?. prescrire international, 2013, vol. 22, no. 144, p. 296–296. .
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Study relevance:
Human health
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Plant part:
Roots and other underground parts (as part-nature) (A067M)
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Type of toxicological test:
case report (CHD060TT)
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Tested organism:
Human (as organism) (A056J)
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Route of exposure:
ORAL: UNSPECIFIED (OECD2234PL)
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Control groups used:
no data
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Endpoint measured:
Dose not reported (CHD066EP)
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Critical effect:
Digestive (TOX18A)
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Target tissue:
digestive: Stomach (TT027A)
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Effect description:
severe adverse gastrointestinal effects: stomach pains, potentially haemorrhagic gastritis and duodenal ulcers
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Effect or parameter linked to the endpoint:
other (CHD003BE)
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Internal remarks:
Potential serious adverse gastrointestinal effects
Endpoint study
#3: [Anonymous]. Devil's claw root: ulcers and gastrointestinal bleeding?. prescrire international, 2013, vol. 22, no. 144, p. 296–296. .
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Study relevance:
Human health
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Plant part:
Roots and other underground parts (as part-nature) (A067M)
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Type of toxicological test:
case report (CHD060TT)
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Tested organism:
Human (as organism) (A056J)
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Route of exposure:
ORAL: UNSPECIFIED (OECD2234PL)
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Control groups used:
no data
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Endpoint measured:
Dose not reported (CHD066EP)
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Critical effect:
PULMONARY AND CARDIAC (TOX08A)
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Target tissue:
cardiovascular / haematological: Heart (TT011A)
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Effect description:
possible cardiac arrhythmia
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Effect or parameter linked to the endpoint:
other (CHD003BE)
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Internal remarks:
Potential cardiac arrhythmia
Endpoint study
#4: Vlachojannis, J., Roufogalis, B. D., Chrubasik, S. Systematic review on the safety of Harpgoophytum preparations for osteoarthritic and low back pain. PHYTOTHERAPY RESEARCH, 2008, vol. 22, no. 2, p. 149–152. DOI: 10.1002/ptr.2314.
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DOI link]
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Study relevance:
Human health
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Plant part:
Roots and other underground parts (as part-nature) (A067M)
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Preparation/Extraction method:
Solvent extraction (A0BZR)
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Additional plant/substance description:
aqueous and ethanol extracts from the roots
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Type of toxicological test:
case report (CHD060TT)
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Tested organism:
Human (as organism) (A056J)
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Route of exposure:
ORAL: UNSPECIFIED (OECD2234PL)
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Number of organisms dosed:
138
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Control groups used:
no data
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Endpoint measured:
Dose level (CHD014EP)
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Concentration unit:
Milligrams per day (G209A)
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Effect concentration:
100
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Critical effect:
Digestive (TOX18A)
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Target tissue:
digestive: Stomach (TT027A)
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Effect description:
Minor adverse events in ~3% of the patients, mainly gastrointestinal adverse events
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Effect or parameter linked to the endpoint:
other (CHD003BE)
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Internal remarks:
Minor adverse events in ~3% of patients, mainly gastrointestinal adverse events.
