• 제목/요약/키워드: double blind

검색결과 549건 처리시간 0.03초

서양산 고추냉이 추출물이 함유된 세치제의 효능에 대한 임상적 실험연구 (A CONTROL OF PLAQUE, GINGIVITIS AND ANTI-CARIES EFFECT OF DENTIFRICE CONTAINING HORSERADISH EXTRACTS)

  • 서현우;박호원;김종수;이시영;신일식
    • 대한소아치과학회지
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    • 제39권1호
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    • pp.26-33
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    • 2012
  • 식물성 자연추출물 중 하나인 고추냉이 추출물을 배합한 세치제의 구강환경 개선 효과를 알아보기위해 총72명을 대상으로 교차실험 및 이중맹검법을 실시하여 치면세균막지수, 치은염지수 및 우식활성도검사 등을 비교 검토한 결과 다음과 같은 결론을 얻었다. 1. 치면세균막지수는 초기값에 비해 대조군은 28%, 고추냉이 추출물 배합세치군은 58%의 억제효과를 나타내었다. 2. 치은염지수는 초기값에 비해 대조군은 26%, 고추냉이 추출물 배합세치군은 40%의 억제효과를 나타내었다. 3. Dentocult-SM을 이용한 우식활성도 평가에서는 초기값에 비해 대조군은 4%, 고추냉이 추출물 배합세치군은 69%의 억제효과를 나타내어 고추냉이 추출물 배합세치군이 대조군에 비해 유의할만한 Streptococcus mutans 억제효과를 나타내었다. 이상의 결과들로 보아 고추냉이 추출물을 배합한 세치제는 치면세균막 억제와 치은염의 감소 그리고 우식활성도 억제에 중요한 역할을 하여 구강환경 개선에 뛰어난 효과를 보이는 것으로 사료된다.

A single-center, randomized, double-blind, placebo-controlled study on the efficacy and safety of "enzyme-treated red ginseng powder complex (BG11001)" for antiwrinkle and proelasticity in individuals with healthy skin

  • Park, Sang-Yong;Shin, Yu-Kyong;Kim, Hee-Taek;Kim, Yong Min;Lee, Don-Gil;Hwang, Eunson;Cho, Byung-Goo;Yin, Chang Shik;Kim, Ki-Young;Yi, Tae Hoo
    • Journal of Ginseng Research
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    • 제40권3호
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    • pp.260-268
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    • 2016
  • Background: During the aging process, skin shows visible changes, characterized by a loss of elasticity and the appearance of wrinkles due to reduced collagen production and decreased elasticity of elastin fibers. Panax ginseng Meyer has been used as a traditional medicine for various diseases due to its wide range of biological activities including skin protective effects. Ginsenosides are the main components responsible for the biological activities of ginseng. However, the protective activities of an enzymatic preparation of red ginseng against human skin aging have not been investigated. Methods: The efficacy of an enzyme-treated powder complex of red ginseng (BG11001) in preventing human skin aging was evaluated by oral administration to 78 randomized individuals. All patients were requested to take three daily capsules containing either 750 mg of BG11001 or a placebo vehicle for 24 wk; at the end of the testing period, skin roughness, elasticity, and skin water content were measured. Results: BG11001 significantly reduced the average roughness of eye wrinkles and the Global Photo Damage Score compared with the placebo, although there were no significant differences in arithmetic roughness average between the groups. In addition, gross elasticity and net elasticity values increased, and transepidermal water loss level decreased, indicating improved skin elasticity and moisture content. Conclusion: In conclusion, enzyme-treated red ginseng extract significantly improved eye wrinkle roughness, skin elasticity, and moisture content. Moreover, enzyme-treated red ginseng extract would be useful substance as a bio-health skin care product.

저열량 식이요법을 한 폐경 전 비만 여성의 휴식 대사량에 대한 마황과 오수유의 효과 (Effect of Ephedra Sinica and Evodia Rutaecarpa on Resting Metabolic Rate in Obese Premenopausal Women during Low-calorie Diet: A Randomized Controlled Clinical Trial)

  • 김수진;고병표;김형도;김진아;박정미;최승기;전우현;김호준
    • 한방비만학회지
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    • 제4권1호
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    • pp.45-54
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    • 2004
  • Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

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건강한 지원자에서 홍삼농축액의 혈행 개선 효과: 무작위, 이중맹검, 위약-대조 시험 (Effect of Korean Red Ginseng Extract on Blood Circulation in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial)

  • 신경섭;이정진;김영일;유지연;박은석;임지현;유순향;오기완;이명구;위재준;김영숙;윤여표
    • Journal of Ginseng Research
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    • 제31권2호
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    • pp.109-116
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    • 2007
  • Korean red ginseng has broad efficacious effects against hypertension, diabetes, nociception, and cancer, and it counteracts weakness. It has been reported that Korean red ginseng is able to normalize blood pressure, improve cholesterol and lower blood glucose levels. We have recently reported that Korean red ginseng extract (KRGE) significantly prevented rat carotid arterial thrombosis in vivo, and inhibited platelet aggregation ex vivo and in vitro in a dose-dependent manner. The purpose of this study was to examine the effects of KRGE on blood circulation in human by measuring ex vivo platelet aggregation, plasma coagulation and serum lipid profiles in healthy volunteers. Subjects were randomly divided into three groups (placebo-group, KRGE-low dose group, KRGE-high dose group). Administration of KRGE to subjects significantly inhibited ADP-induced platelet aggregations both in KRGE-low dose group from $72.79{\pm}20.53$ to $62.00{\pm}23.06%$ (p=0.0009), and in KRGE-high dose group from $75.14{\pm}21.86$ to $64.52{\pm}24.72%$ (p=0.0039), respectively. Administration of KRGE to subjects also significantly inhibited collagen-induced platelet aggregations both in KRGE-low dose group from $85.52{\pm}12.57$ to $79.62{\pm}20.47%$ (p=0.0916), and in KRGE-high dose group from $80.24{\pm}18.11$ to $70.31{\pm}25.93%$ (p=0.0565), respectively. Whereas, KRGE has no significant effects on coagulation system, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), and serum lipid profiles, such as total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol and triglyceride. KRGE also has no significant effects on hematological and serum biochemical profiles. These results suggest that KRGE has a potential to improve blood circulation through antiplatelet activity in human, and KRGE intake may be beneficial for the individuals with high risks of thrombotic and cardiovascular diseases.

Safety and tolerability of Korean Red Ginseng in healthy adults: a multicenter, double-blind, randomized, placebo-controlled trial

  • Song, Sang-Wook;Kim, Ha-Na;Shim, Jae-Yong;Yoo, Byeong-Yeon;Kim, Dae-Hyun;Lee, Sang-Hyun;Park, Joo-Sung;Kim, Moon-Jong;Yoo, Jun-Hyun;Cho, BeLong;Kang, Hee-Cheol;Kim, Kwang-Min;Kim, Sung-Soo;Kim, Kyung-Soo
    • Journal of Ginseng Research
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    • 제42권4호
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    • pp.571-576
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    • 2018
  • Background: Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks. Methods: We randomized 1,000 participants in a 1:1 ratio into two groups, which were treated daily with 2 g of KRG or a placebo for 24 weeks. The primary endpoint was all adverse events and adverse drug reactions (ADRs) that occurred after KRG or placebo administration, which were reported at week 4, 12, and 24 after the baseline visit. Results: In total, 192 and 211 participants experienced adverse events in the KRG and placebo groups (39.2% and 42.0%, respectively; p = 0.361), and 59 and 57 KRG- and placebo-treated individuals reported ADRs (12.0% and 11.4%, respectively; p = 0.737). The frequently occurring ADRs were pruritus (2.0%), headache (1.6%), diarrhea (1.4%), and dizziness (1.2%) in the KRG group and pruritus (2.0%), headache (1.8%), dizziness (1.6%), rash (1.4%), and diarrhea (1.2%) in the placebo group. Discontinuation of drug administration due to ADRs was reported in 13 participants, six (1.2%) and seven (1.4%) in the KRG and placebo groups, respectively (p = 0.814). No significant abnormal changes were revealed by anthropometric, laboratory, and vital sign measurements in the KRG group compared with those in the placebo group. Conclusion: The present study confirms the safety and tolerability of daily intake of 2 g of KRG for 24 weeks by healthy adults.

폴리칸이 중년 여성의 골대사에 미치는 영향: 12주간의 무작위배정, 이중눈가림, 플라세보 대조 연구 (Effects of Polycan on bone Metabolism in healthy Perimenopausal Women: a 12-week Randomized, Double-blind, Placebo-controlled study)

  • 김민걸;하기찬;백향임;김선영;김주완;김기영;조형래;채한정;채수완;김달식
    • 한국임상약학회지
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    • 제21권4호
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    • pp.297-304
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    • 2011
  • 배경: 골다공증은 골대사의 불균형으로 인해 골 흡수가 골 형성보다 많아져 골밀도가 감소함으로서 발생한다. 골다공증의 이상적인 치료목표는 골형성을 증가시키거나 골소실을 방지하여 골량을 현 상태로 유지하는 것이다. 따라서 향후 발생되는 골소실을 에방하는 것이 골다공증의 원칙적이고 효과적인 치료방법이 될 것이다. 본 연구에서는 흑효모 중 $Aureobasidium$ $pullulans$으로부터 유래한 폴리칸(베타-글루칸)이 중년여성의 골대사에 미치는 영향을 규명하고자 하였다. 연구방법: 골대사에 대한 폴리칸의 효과를 규명하기 위해 12주간의 무작위배정, 이중눈가림, 플라세보 대조 임상연구를 수행하였다. 총 60명(폴리칸 투여군30명, 플라세보 투여군 30명)의 중년 여성 피험자가 등록되어 이 중 총 58명의 피험자가 최종적으로 12주간의 임상연구를 종료하였다. 결 과: 폴리칸(150 mg/d) 투여 12주 후, 폴리칸 투여군은 요 중 Deoxypyridinoline (DPD) 농도가 유의적인 감소를 보였다($P$=0.014). 혈청 중 Osteocalcin(OSC) 농도는 두 군 모두에서 유의적으로 증가하였으며, bone-specific alkaline posphatase (bALP) 와 collagen type 1 cross-linked C-telopeptide (CTx)는 유의적 변화가 보이지 않았다. 폴리칸은 골밀도(BMD)와 혈청 부갑상선 호르몬(iPTH)에 대해 유의적인 변화를 보이지 않았으나, 24시간 요 중 Ca 배설량은 폴리칸 투여군에서 유의하게 감소되었다($P$=0.028). 또한 폴리칸 투여군에서 고밀도지단백 콜레스테롤(HDL-cholesterol) 농도의 증가 경향 및 중성지방(triglyceride)의 유의적인 감소가 보였다. 임상연구 기간 중에 발생한 이상반응은 두 군간에 유의적인 차이를 보이지 않았다. 결 론: 본 연구에서는 폴리칸이 골대사 및 지질에 대해 일부 개선효과가 있음을 보여주었다. 그러나, 골다공증 예방 측면에서 보다 장기적인 임상연구와 피험자 수를 확대하여 골대사 및 지질대사에 대한 폴리칸의 예방적 효과를 규명할 필요가 있을것으로 사료된다.

칠제향부환(七製香附丸)이 원발성(原發性) 월경통(月經痛) 환자(患者)의 복부(腹部) 및 수장부(手掌部) 온도(手掌部 溫度)에 미치는 영향(影響) (The effect of Chiljehyangbuhwan on the abdomial & palmar temperature in the primary dysmenorrhea patients)

  • 이창훈;조정훈;장준복;이경섭;윤영진
    • 대한한방체열의학회지
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    • 제5권1호
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    • pp.46-58
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    • 2006
  • Purpose: We intended to observe the relations between Chiljehyangbuhwan and abdominal & palmar temperature according to primary dysmenorrhea severity. Methods: We selected the 100 primary dysmenorrhea patients by the screening tests (first screening test-inquiry, second screening test-clinical test. additionally WHR (Waist-to-Hip ratio) by Inbody 2.0). By the fixed blocked randomization and double blind method, Chiljehyangbuhwan or placebo was administered for 1 menstration period. Finally, 69 patients remainded. Before and after administration, we measured 4 points abdominal temperature (Chon-jung (CV17), Chung-wan(CV12), Kwan-won(CV4). Chung-guk(CV3)) by DITI(DOREX Inc., USA). And then we checked the difference of temperature $({\Delta}T)$ between CV17 and CV12/CV17 and CV4/CV17 and CV3/CV12 and CV4/CV12 and CV3. Also, we measured 2 points (palmar region, upper front of forearm) for the difference of palmar temperature $({\Delta}T)$. Then, we checked palmar temperature minus upper front of forearm temperature and took an average of right and left ${\Delta}T.$ After that. we compared ${\Delta}T$ with primary dysmenorrhea severity evaluated by VRS (verbal rating scale) and MVRS (multidimensional verbal rating scale). In dysmenorrhea severity. we standardized scale score and 3-group-severity by score (mild, moderate. severe). Besides, we compared palmar ${\Delta}T$ with abdominal ${\Delta}T$. For statistics, we used ANOVA and Spearman's rho correlations. SPSS 13.0 for windows. Results: In case of MVRS, though Chiljehyangbuhwan was correlated to abdominal ${\Delta}T$(CV12 and CV3/CV12 and CV4). it was not correlated to palmar ${\Delta}T$. In case of VRS, though Chiljehyangbuhwan was not correlated to abdominal ${\Delta}T$. it was correlated to palmar ${\Delta}T$. However. palmar ${\Delta}T$ was not correlated to abdominal ${\Delta}T$. Statistically they showed significant result (p<0.05). Conclusion: The primary dysmenorrhea patients showed that severity by MVRS was connected with abdominal ${\Delta}T$ (CV12 and CV3/CV12 and CV4) and severity by VRS was connected with palmar ${\Delta}T$ after Chiljehyangbuhwan administration. So we can consider Chiljehyangbuhwan partially effects the abdominal & palmar temperature according primary dysmenorrhea severity. However, palmar temperature was not correlated to abdominal temperature. Therefore, we need further study.

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Prognostic Factor Analysis of Overall Survival in Gastric Cancer from Two Phase III Studies of Second-line Ramucirumab (REGARD and RAINBOW) Using Pooled Patient Data

  • Fuchs, Charles S.;Muro, Kei;Tomasek, Jiri;Van Cutsem, Eric;Cho, Jae Yong;Oh, Sang-Cheul;Safran, Howard;Bodoky, Gyorgy;Chau, Ian;Shimada, Yasuhiro;Al-Batran, Salah-Eddin;Passalacqua, Rodolfo;Ohtsu, Atsushi;Emig, Michael;Ferry, David;Chandrawansa, Kumari;Hsu, Yanzhi;Sashegyi, Andreas;Liepa, Astra M.;Wilke, Hansjochen
    • Journal of Gastric Cancer
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    • 제17권2호
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    • pp.132-144
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    • 2017
  • Purpose: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. Materials and Methods: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. Results: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64-0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. Conclusions: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.

엉겅퀴 추출물 실리마린의 피부 미백효과 (Hypopigmentary Effect of Milk Thistle Extract Silymarin)

  • 유익동;추수진;류인자;김영희;허광화;김기호;한창성;김수진;김진웅;손의동
    • 대한화장품학회지
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    • 제35권2호
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    • pp.151-158
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    • 2009
  • 천연물로부터 새로운 미백 소재를 개발하기 위하여 식물 추출물들의 미백활성을 조사한 결과, 엉겅퀴의 열매로부터 추출한 silymarin이 우수한 미백효과를 나타내는 것을 발견하였다. Silymarin으로부터 유효 성분을 분리하기 위하여 각종 컬럼 크로마토그래피 및 HPLC 등의 기법을 실시하여 silybin과 isosilybin을 분리한 후 이성질체인 silybin A와B, 그리고 isosilybin A와 B를 각각 순수 분리하였다. Silymarin은 Mel-Ab melanocyte에서 세포독성에 영향을 주지 않는 동시에 멜라닌의 생성을 억제하였고 $IC_{50}$ 값은 28.2 ${\mu}g/mL$이었다. 또한 Silymarin은 cell-based tyrosinase의 활성을 저해하고, western blot 분석 결과 tyrosinase 단백질의 발현을 감소시키는 것을 확인하였다. Silymarin으로부터 분리한 활성 화합물인 silybin 및 isosilybin의 미백 효과를 측정한 결과, 각각 42.25 ${\mu}M$ 및 16.32 ${\mu}M$$IC_{50}$ 값을 가지며 멜라닌의 생성을 억제하였으며 tyrosinase 단백질의 발현을 감소시켰다. Diastereoisomer 형태로 존재하는 silybin A 및 B, 그리고 isosilybin A 및 B의 멜라닌 저해활성을 측정한 결과, 네 가지 화합물 모두 농도 의존적으로 멜라닌의 생성을 억제하는 것으로 나타났다. 또한, 피부 미백 임상연구를 실시한 결과, silymarin 2 % 함유 크림을 사용할 경우 피부 미백 효과가 유효하게 나타남을 확인하였다. 이상의 결과로부터 본 활성물질 silymarin은 피부 미백 효과가 우수한 안전한 화장품 원료로서 사용할 수 있을 것으로 사료된다.

하고초 추출물의 항노화 효과에 관한 연구 (The Study on the Potential Anti-aging Properties of Prunella vulgaris Extract In Vitro and In Vivo)

  • 홍은숙;안기웅;조병기
    • 대한화장품학회지
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    • 제34권2호
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    • pp.129-135
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    • 2008
  • 본 연구에서는 하고초(Prunella vulgaris) 추출물의 항노화 효과에 대하여 알아보고자 하였다. 시험 결과, 하고초 추출물의 콜라겐 생성 촉진 효과는 250 ${\mu}g/mL$ 농도에서 75.7%, MMP-1 생성 억제 효과는 200 ${\mu}g/mL$ 농도에서 90.2%로 나타났고, 엘라스테이즈 활성 억제 효과는 2.0% 농도에서 43.7%로 나타났다. 또한, 하고초 추출물의 항산화 효과 측정을 위한 자유 라티칼 소거 효과 시험 결과 2.0% 농도에서 76.9%의 소거 효과를 나타내었으며, 과산화수소에 의한 세포사멸 억제 효과는 2.0% 농도에서 49.9%로 나타났다. 하고초 추출물의 피부에 대한 영향을 알아보기 위하여 22명(연령분포 : 34세$\sim$48세)의 지원자를 대상으로 실시한 이중 맹검 임상 연구 결과, 하고초 추출물 4.0% 함유 제형을 12주간 도포하였을 때, 대조군과 비교하여 전문가의 육안평가, 모사판을 제작하여 주름의 정도를 분석한 결과 주름 개선에 현저한 효과가 있음을 확인하였다(p<0.05). 이러한 결과를 통해 하고초 추출물은 피부의 탄력과 주름을 효과적으로 개선함으로써, 천연 항노화 소재로 유용하게 이용될 수 있을 것으로 기대된다.