Dataset Information

Acute and repeated toxicological study of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, in beagle dogs.

ABSTRACT:

Background

To evaluate the pharmaceutical safety of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, using both acute and repeated toxicological studies.

Methods

A total of 40 beagle dogs (20 each male and female) were fed doses up to 5,000 mg/kg for the acute study and up to 1,250 mg/kg for the 13-week repeated dose toxicological study. Adverse effects were examined intensively by comparing the differences between normal and drug-administered groups using clinical signs, autopsies, histopathological findings, hematology, urinalysis, and biochemical analysis.

Results

No mortality or drug-related clinical signs were observed in the Myelophil-treated groups, except for vomiting due to an excessive dose (5,000 mg/kg). Likewise, in the repeated toxicity test, compound-colored stools in the Myelophil-treated groups and soft stools in all groups, including the control, were observed. No drug-related abnormalities were found in the histopathology, hematology, urinalysis, and biochemical analyses for any doses of Myelophil.

Conclusion

These results support the safety of Myelophil with a no observed adverse effect level (NOAEL) of 1250 mg/kg in beagle dogs, which corresponds to a human equivalent dose (HED) of 694 g/kg.

SUBMITTER: Joung JY

PROVIDER: S-EPMC6615141 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Publications

Acute and repeated toxicological study of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, in beagle dogs.

Joung Jin-Yong JY Lee Jin-Seok JS Cho Jung-Hyo JH Lee Dong-Soo DS Son Chang-Gue CG

BMC complementary and alternative medicine 20190708 1

<h4>Background</h4>To evaluate the pharmaceutical safety of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, using both acute and repeated toxicological studies.<h4>Methods</h4>A total of 40 beagle dogs (20 each male and female) were fed doses up to 5,000 mg/kg for the acute study and up to 1,250 mg/kg for the 13-week repeated dose toxicological study. Adverse effects were examined intensively by comparing the differences between normal and drug-admi ...[more]

PMID: 31286942

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Project description:Background: There is a strong demand for therapeutics to treat chronic fatigue syndrome (CFS), although there are limitations. Myelophil, which is a combination of extracts from Astragali Radix and Salviae Miltiorrhizae Radix, has been clinically used to treat fatigue-related disorders in South Korea. We conducted a randomized controlled clinical trial of Myelophil in patients with CFS and evaluated its efficacy and safety in two hospitals. Methods: We enrolled 98 participants (M: 38, F: 60) with CFS in a phase 2 trial of oral Myelophil (2 g daily) or placebo for 12 weeks. The primary end point was a change in the Chalder fatigue scale, as scored by a numeric rating scale (NRS). The secondary end points included changes in the visual analogue scale, fatigue severity scale (FSS), and 36-item short-form health survey (SF-36). Biomarkers of oxidative stress and cytokines were evaluated by blood tests. Results: Ninety-seven participants (48 in the Myelophil group and 49 in the placebo group) completed the trial. An analysis of all participants showed that Myelophil slightly improved fatigue symptoms compared with those of the placebo, but this effect was not statistically significant (p > 0.05 for the NRS, VAS, FSS, and SF-36). By contrast, an analysis of the subpopulation (53 participants, M: 24, F: 29) with severe symptoms (≥63, median NRS value of total participants) showed a statistically significant improvement in fatigue symptoms in the Myelophil group compared with the placebo (p < 0.05 for NRS, FSS, and SF-36). There were no significant changes in the biomarkers for oxidative stress and cytokines before or after the treatment. No Myelophil-related adverse response was observed during the trial. Conclusion: These results support the hypothesis that Myelophil can be a therapeutic candidate to manage CFS and provide the rationale for its progression to a phase 3 clinical trial. Clinical Trial Registration: www.ClinicalTrials.gov, identifier KCT0002317.

Dataset Information

Acute and repeated toxicological study of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, in beagle dogs.

Background

Methods

Results

Conclusion

Publications

Acute and repeated toxicological study of Myelophil, an ethanol extract of a mixture of Astragali Radix and Salviae Miltiorrhizae Radix, in beagle dogs.

Similar Datasets

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