• Biomolecules & Therapeutics
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• v.4 no.1
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• pp.19-31
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• 1996

This study was performed to determine the subacute toxicities of SKI306X, an antiinflammatory herbal extract, in rats. SKI306X was administered orally to rats once a day for 4 weeks at doses of 0.3, 1.0, and 3.0 g/kg/ day. Each group consisted of 20 male and 20 female rats, including 5 male and 5 female rats per group for an interim study at the end of 2-week administration and for a 2-week recovery study, respectively. Throughout the study, all rats survived and no adverse clinical signs were observed. Although male rats treated with high dose (3.0 g/kg/day) of SKI306X showed slight loss of body weight (approximately 5%) in comparison with control animals during the administration period, their body weight loss was normally restored during the recovery period. No significant change was found in all hematological parameters of SKI306X-treated groups except for the decreased number of red blood cells in all female groups at the interim study. Statistically significant changes were observed in several blood enzyme levels of SKI306X-treated groups; however, most of these significant changes were within normal range and statistically significant values did not show dose-related responses. In SKI306X-treated groups, the absolute and relative weights of liver, heart, and stomach were statistically different from those of control group, but these differences disappeared at the end of recovery period and also drug-related gross and histopathological findings in these organs were not found. No other drug-related gross and histopathological findings were observed. It is concluded from the results of this study that non-toxic dose of SKI306X was estimated to be between 0.3 and 1.0 g/kg/day and the maximum tolerated dose of SKI306X was assumed to be higher than 3.0 g/kg/day.

• Biomolecules & Therapeutics
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• v.4 no.1
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• pp.32-35
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• 1996

SKI306X is a herbal extract prepared from three herbs Clematis mandshurica, Trichosanthes kirilowii and Prunella vulgaris. It showed strong antiinflammatory actions on carrageenan-induced edema, acetic acid-induced pain, adjuvant-induced arthritis, and oxygen radical-generated reactions. In this study, the acute toxicity of SKI306X was evaluated in rats by a single oral administration. Thirty male and thirty female rats were divided into 6 groups according to the dose levels, respectively. After oral administration of SKI306X with several doses (5.0 g/kg, 3.3 g/kg, 2.2 g/kg, 1.5 g/kg, 1.0 g/kg), mortality, clinical signs, body weight, and gross findings in organs were examined. No toxic effect was shown in terms of mortality, clinical signs, body weight changes and gross findings. It is suggested the LD$_{50}$ of SKI306X would be more than 5.0 g/kg in rats.s.

• YAKHAK HOEJI
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• v.39 no.4
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• pp.385-394
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• 1995

Antiinflammatory activities of the solvent fractionates of several herbal medicines were investigated and SKI306X was prepared from the active principles of three herbal medicines, Prunella vulgaris, Trichosantlies kirilowii and Clematis mandshurica. SK1306X was shown to have strong inhibitory effects on acetic acid-induced pain, carrageenan-induced paw edema and adjuvant induced arthritis. LD50 of SKI306X was more than 5 g/kg in rat, so generally nontoxic. Chemical analysis revealed that oleanolic acid and rutin, which are known to have various antiinflammatory activities, were contained in it. These results suggest SK1306-X may become a useful drug for the treatment of inflammatory diseases such as rheumatoid arthritis.

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.143.2-144
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• 2003

Joins (SKI 306X) is now clinically used for the treatment of osteoarthritis (OA). In previous reports, Joins a natural herbal product extracted from three herbs Clematis Radix. Trichosanthes Radix and Prunella Flos, was shown to have good analgesic and anti-inflammatory effects in several in vivo models. e.g., acetic acid-induced pain, carrageenan-induced paw edema and adjuvant-induced arthritis. (omitted)

• 대한예방의학회:학술대회논문집
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• 2001.10a
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• pp.302-304
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• 2001

• Proceedings of the PSK Conference
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• 2003.04a
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• pp.146.1-146.1
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• 2003

Joins (SKI 306X) is now clinically used for the treatment of osteoarthritis (OA). In previous reports, Joins, a natural herbal product extracted from three herbs Clematis Radix, Trichosanthes Radix and Prunella Flos, was shown to have good analgesic and anti-inflammatory effects and cartilage protective effects in several experimental models. In this study we characterized the effects of Joins on the gastric mucosa and compared to that of diclofenac. (omitted)

• 대한임상약리학회:학술대회논문집
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• 2001.12a
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• pp.24-25
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• 2001

• Journal of Preventive Medicine and Public Health
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• v.37 no.4
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• pp.381-389
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• 2004

Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

• Proceedings of the PSK Conference
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• 2001.10a
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• pp.155.2-156
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• 2001

• Proceedings of the PSK Conference
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• 2001.10a
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• pp.141.1-141.1
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• 2001