@article {2235, title = {Safety Assessment of Oral Lysiphyllum strychnifolium Aqueous Extract in Healthy Volunteers}, journal = {Pharmacognosy Journal}, volume = {16}, year = {2024}, month = {February 2024}, pages = {235-240}, type = {Research Article}, chapter = {235}, abstract = {

Background: Lysiphyllum strychnifolium (LS), widely known as Ya nang daeng in Thailand, is a traditional herbal remedy that has long been used to promote health and treat diverse health conditions, especially detoxification, by alleviating the severity of symptoms and lowering the risks associated with toxic exposures. Although it is extensively used in Thailand, human safety studies have been lacking. Thus, this study aimed to examine the safety of using LS capsules in healthy participants through a Phase I clinical trial. Objective: This study aimed to investigate the safety of aqueous extract of LS in twenty-four healthy Thai participants. Method: The participants were received 1,000 mg of LS aqueous extract each morning before their meals for seven days. All participants were examined safety assessment including history taking, physical examination, and laboratory tests at day 0, 8 and 14 (follow-up). Results: The findings showed that there were no significant side effects or abnormalities found during the history taking, physical examination, or laboratory evaluation. Particularly, when compared to baseline, participants who received LS experienced statistically significant reductions in blood sugar, triglyceride, LDL cholesterol, and creatinine (P \< 0.05), but still within normal ranges. Conclusions: Dietary supplementation with 1,000 mg of LS aqueous extract per day may have a beneficial effect on blood sugar and cholesterol management while remaining safe for healthy people.

}, keywords = {Clinical study, Healthy volunteers, Lysiphyllum strychnifolium, Safety, Yanang Daeng}, doi = {10.5530/pj.2024.16.34}, author = {Piracha Jumpa-ngern and Parunkul Tungsukruthai and Chuntida Kamalashiran and Somboon Kietinun and Kesara Na- Bangchang and Kusuma Sriyakul} } @article {2149, title = {Safety Assessment of Supplementation with Cymbopogon citratus Stapf. (Lemongrass) Extract in Patients with Chronic Kidney Disease Stage 3: A Preliminary 90-Days Prospective Study}, journal = {Pharmacognosy Journal}, volume = {15}, year = {2023}, month = {December 2023}, pages = {976-986}, type = {Original Article}, chapter = {976}, abstract = {

Background: Chronic kidney disease is a major public health issue, and due to resource constraints, many can{\textquoteright}t access dialysis. C. citratus, lemongrass is globally prevalent and known to increase urine output without toxicity. Objective: To examine the safety of C. citratus in patients with CKD stage 3. Materials and Methods: The major compound of C. citratus was analyzed using high-performance liquid chromatography (HPLC). 64 patients were enrolled and randomly assigned to control or C. citratus groups. The control group received a placebo, whereas the C. citratus group received 900 mg of C. citratus daily for 90 days. All participants were examined BUN, Scr, Cys-C, and eGFR, liver functions, RBC, HCT, Na+, K+, Cl-, and HCO3, and other biochemical parameters. Results: HPLC showed C. citratus contains of phenolic compounds. Clinically, C. citratus group had no notable side effects on T-Bil, AST, ALT and ALP. Also, maintained eGFR, SCys-C, K+ and Cl level. The level of blood Na+ was significant increase at day 30 (p \< 0.05). The control group had a significant decrease in eGFR and HCO3 levels (p \< 0.05) and a significant increase of Cl- and SCys-C. In addition, no statistical differences had found between groups in eGFR, BUN, Cr, Na+, K+, HCO3, PO4, RBC and HCT levels. Throughout the 90 days, no drug allergies or side effects were reported. Conclusion: Dietary supplementation with C. citratus may have a favorable effect on delaying the course of CKD and is safe to use for patients with CKD stage 3.

}, keywords = {Chronic Kidney Disease, CKD stage 3, Cymbopogon citratus Stapf., Lemongrass, Safety}, doi = {10.5530/pj.2023.15.181}, author = {Patnaree Wongmanit and Parunkul Tungsukruthai and Pratya Phetkate and Daraporn Rungprai and Sucharat Tungsukruthai and Ouppatham Supasyndh and Kusuma Sriyakul} } @article {1861, title = {Acute Oral Toxicity Assessment of Freeze-Dried Lipote Fruit Extract (Syzygium polycephaloides (C. B. Rob.) Merr.) in ICR Mice}, journal = {Pharmacognosy Journal}, volume = {14}, year = {2022}, month = {October 2022}, pages = {490-503}, type = {Original Article}, chapter = {490}, abstract = {

Introduction: Lipote (Syzygium polycephaloides (C. B. Rob.) Merr.) has been traditionally used in Ayurvedic medicine due to its nutritional and bioactive contents. Methods: An acute oral toxicity test was conducted following the OECD 425 guidelines to investigate the toxic effects of freeze-dried lipote fruit extract (LFE) in male and female ICR mice at doses of 55, 175, 550, 2000, and 5000 mg/kg BW. Results: At the end of the 14-day experimentation period, no physical, behavioral, neurologic, or cardiorespiratory signs of toxicity nor mortalities were recorded in LFE-treated mice. Also, physiologic parameters such as body weight, and feed and water intake registered normal throughout the study. Hematologic values such as total RBC, total WBC, and differential WBC for both sexes remained normal, apart from the male mouse administered with 2000 mg/kg LFE dose which presented erythrocytopenia, leukocytopenia, and lymphocytopenia after the end of the experimentation period, most likely due to extraneous factors unrelated to treatment. Meanwhile, the blood creatinine and blood urea nitrogen values remained within their respective normal reference ranges. Conclusion: It can be inferred from results of this acute oral toxicity study that LFE is relatively non-toxic, has an LD50 above 5000 mg/kg, and like other closely related Syzygium berries, does not elicit any adverse effects on the physiologic, hematologic, and blood chemical levels of kidney-filtered substances in mice. Sub-chronic and chronic toxicity studies must be conducted to determine the safety of continuous oral ingestion of lipote fruit.

}, keywords = {Acute toxicity, Lipote, Mice, Philippine berry, Safety}, doi = {10.5530/pj.2022.14.126}, author = {Mark Joseph M. Desamero and Liezl M. Atienza and Maria Adrianna Isabella G. Claravall and Roxanne P. Gapasin and Jonna Rose C. Maniwang and Dianne Jane A. Sunico and James Ryan D. Aranzado and Joan I. Delomen and Loraine C. Bainto-Ancheta and Katherine Ann T. Castillo-Israel and Rohani B. Cena-Navarro and Maria Amelita C. Estacio} } @article {1883, title = {Phytochemical Test and Acute Safety Evaluation of Oral Purple Leaves (Graptophyllum Pictum L. Griff) Extract in Rats}, journal = {Pharmacognosy Journal}, volume = {14}, year = {2022}, month = {October 2022}, pages = {649-654}, type = {Research Article}, chapter = {649}, abstract = {

Background: Purple leaves (Graptophyllum pictum (L) Griff) is a native plant from Indonesia (Polynesia) which is empirically common used to treat hemorrhoids, diabetes, and many other diseases. Despite its massive development globally, there are few studies have written about the toxicity of this herbal medicine. Aim: The aim of this study is to describe the acute toxicity of this herbal medicine, as the basic ground of the further safe development of this medicine. Method: Each purple leaf dry powder (2 kg) was extracted with 15 L of 70\% ethanol and 15 L of hexane by maceration method for 3 days at room temperature and then filtered to obtain macerate liquid. The study was conducted on 36 male 6-8 weeks, Sprague{\textendash}Dawley (SD) rats. The result was presented as the mean value {\textpm} standard deviation (SD). Data were evaluated for homogeneity using Saphiro Wilk. The comparisons between pre dan post treatment body weight were measured by paired student t test and hematological measurements were analyzed by ANOVA. P value less than 0.05 was considered significant. Results: Acute toxicity of ethanol and hexane extract were assessed following a single dose administered by gavage at a dose of 50, 2000 and 3000 g/kg bw. The mean body weight of rats increased from 150 {\textpm} 2.22 g to 161 {\textpm} 6.68 g during the 14 days. The difference of body weight between before and at 14 days amongs groups were significantly different with P value \<0.01. Conclusion: The present study showed that hexane extract contains more valuable components for medical treatment purposes. The acute toxicity on 50, 2000,3000 kg/BW oral ethanol and hexane extract of Graptophyllum pictum showed no significant influence on hematological blood parameters of rats. It is safe to administered orally ethanol or hexane extract of G. pictum below 3000mg/kgBW rats.

}, keywords = {Acute, purple leaves, Safety, Toxicity}, doi = {10.5530/pj.2022.14.148}, author = {Feda Makkiyah and Eldiza Puji Rahmi and Yuni Setyaningsih} } @article {1303, title = {Evaluation of Myrmecodia pendans Water Extracts on Hematology Profiles, Liver, Kidney Function and Malondialdehyde Level in Healthy Volunteer}, journal = {Pharmacognosy Journal}, volume = {12}, year = {2020}, month = {November 2020}, pages = {1489-1493}, type = {Original Article}, chapter = {1489}, abstract = {

Background: Ant Nest (Myrmecodia pendans) is one of plants that have been used by locals in Indonesia to empirically treat various diseases. Ant Nest in vitro and in vivo studies on animals have been widely reported its pharmacological activities as an antioxidant. Unfortunately, scientific proofs reported on this plant as human medicine are still lacking. Aim: This study aimed to ensure effectiveness, and safety due to administration of Ant Nest Water Extract (ANWE) formulated in capsule. Materials and Methods: Twelve volunteers were divided into 2 groups, 6 volunteers in each group. Group I: Ant Nest Water Extract Capsule (ANWEC) in dose of 350 mg ANWE, and group II: Placebo Capsule (PC) which contained 350 mg amylum. Each groups given the capsule once daily for 28 days. The comparison was made between group I and group II. Hematology tests include hemoglobin, leucocyte and thrombocyte. Blood chemistry tests include SGOT, SGPT, total cholesterol, triglycerides, HDL, LDL, glucose, ureum (Ur) and creatinine (Cr). Malondialdehyde (MDA) level was measured at day-28 which was the last day of the intervention. Results: After 28 days administration of ANWE, the SGOT, SGPT, Ur, and Cr showed in normal level as follows SGOT (U/L): 19.2 {\textpm} 3.99; SGPT (U/L): 17.2 {\textpm} 6.80; Ur (mg/dL): 19.75 {\textpm} 3.66; Cr (mg/dL): 1.06 {\textpm} 0.13. MDA (ng/mL) level in ANWEC-treated group was significantly lower (117.2{\textpm}23.8) than PC (147.25{\textpm}18.7). There was no intolerable complaints during the observation. Conclusion: The study concluded that Water Extract of Ant Nest 350 mg has no damage to liver, kidney and hematology, so it was proven that this plant is safed to be consumed by human for its potency as antioxidant.

}, keywords = {Antioxidant, Malondialdehyde, Myrmecodia pendans, Safety}, doi = {10.5530/pj.2020.12.204}, author = {Tri Widyawati and M Aron Pase and Milahayati Daulay and Imam Bagus Sumantri and Nor Adlin Yusoff} } @article {346, title = {Preliminary Acute Oral Toxicity Study of White Tea Leaf (Camellia sinensis (L.) Kuntze) Ethanolic Extracts}, journal = {Pharmacognosy Journal}, volume = {9}, year = {2017}, month = {May 2017}, pages = {479-482}, type = {Original Article}, chapter = {479}, abstract = {

Background: White tea is a kind of tea which manufactured with minimal processing only drying without fermentation process. White tea prepared from very young tea leaves or buds of Camellia sinensis (L.) Kuntze, Theaceae, covered with tiny, silvery hairs, and dried immediately after picking to prevent oxidation and commonly used as a beverage and herbal medicine. Objective: The present study was aimed to evaluate the safety of the white tea leaf ethanolic extract (WTE) with acute toxicity tests. Methods: The acute oral toxicity of WTE performed at dose 1250, 2500, and 5000 mg/Kg BW of Deutschland, Denken, and Yoken (DDY) mice. The animals observation for any mortality, behavioral, body weight and feed-water consumption pattern during the 14- day study. The liver, kidney, and heart isolation performed on day-15 to observe macroscopic and relative organ weight (ROW). Results: No treatment-related toxic symptom or mortality observed for the first 4 hours and 24 hours after oral administration of WTE at a dose of 1250, 2500, and 5000 mg/kg BW. All the groups of mice did not show the significant changes in behavior, breathing, and motoric activity. Conclusions: This studies showed that the oral LD50 of WTE was greater than 5000 mg/kg BW and suggests that the WTE is practically non-toxic in a single dose of level 5000 mg/kg BW.

}, keywords = {Acute toxicity, Camellia Sinensis (L.) Kuntze, Safety, Teh Putih, Theaceae}, doi = {10.5530/pj.2017.4.77}, url = {/files/PJ-9-4/10.5530pj.2017.4.77}, author = {Lia Ardiana and Meiliza Ekayanti and Sarah Zielda Najib and Rani Sauriasari and Berna Elya} }