• 제목/요약/키워드: Pilot clinical trial

검색결과 71건 처리시간 0.033초

암성통증에 대한 SBVP 효과 - 무작위대조시험, 이중맹검 (The Effect of Sweet Bee Venom Pharmacopuncture(SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study)

  • 유화승;김정선
    • 대한약침학회지
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    • 제11권1호
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    • pp.21-29
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    • 2008
  • Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

월경곤란증의 자하거 약침효과에 관한 연구 (Effect of Hominis placenta Pharmacopuncture on the Dysmenorrhea (A Pilot study, Single blind, Randomized, Controlled Clinical Trial))

  • 김수민;장선희;김철홍;윤현민;송춘호;안창범;장경전
    • 대한약침학회지
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    • 제11권3호
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    • pp.123-131
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    • 2008
  • Objective: This study was designed to evaluate the effect of Hominis placenta Pharmacopuncture treatment on Dysmenorrhea of Women. Methods: 49 subjects who were suffering from dysmenorrhea volunteered to answer the MMP(Measure of Menstrual Pain) and MSSL(Menstrual Symptom Severity List) questionnaire. They were divided into two groups, a Hominis placenta Pharmacopuncture treatment group(Experiment al group, n=25) and a Normal Saline(N/S) treatment group(Control group, n=24). The two groups were injected on the $CV_4,\;S_{36},\;Sp_9$ and $Sp_6$ acupuncture point. They were treated totally five times depending on the individual menstruation cycles. The scores of MMP and MSSL were measured overall three times before and after the menstruation cycle. The collected data were analyzed as paired t-test, independent t-test using SPSS 12.0 WIN Program. Results: As a result of the evaluation by MMP and MSSL, a significant improvement on dysmenorrhea was made in the two groups(p<0.05), and both scores of Experiment group were decreased more than Control group. But there was no significant difference between the two groups. Conclusions: The Hominis placenta Pharmacopuncture treatment and the Normal Saline treatment were effective in decreasing the symptom of Dysmenorrhea.

Therapeutic Potential of Atopy-camp: A pilot study

  • Lee, Nam-Ryul;Kim, Hyung-Geug;Seo, Kyoung-Suk;Son, Chang-Gue
    • 대한한의학회지
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    • 제31권6호
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    • pp.40-46
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    • 2010
  • Objective: This study investigated the therapeutic possibility of natural therapy in atopy-camp for children with atopic dermatitis. Methods: 30 children (19 boys and 11 girls, median age 11.5 years, ranging from 9 to 15) participated in natural environment-based activities in a camp-village located in Geumsan-gun for five days. Assessment of symptom change was conducted by self-reporting numeric scale (NRS) for pruritus and sleeping difficulty, investigator global assessment (IGA), eczema area and severity index (EASI score), serum histamine and IgE concentration before and after the camp period. Statistical significance was analyzed by paired t-test. Results: NRS for pruritus ($4.7{\pm}2.0$ into $4.3{\pm}2.1$), sleeping difficulty ($3.1{\pm}2.1$ into $2.9{\pm}2.0$), and serum histamine concentration ($4.27{\pm}7.39$ mol / L into $3.21{\pm}6.08$ mol / L) showed positive changes but didn't reach statistical significance (p > 0.05). IGA ($3.8{\pm}0.9$ into $4.13{\pm}1.0$), while EASI score ($10.8{\pm}9.7$ into $9.1{\pm}9.2$) and IgE ($408{\pm}320$ IU / mL into $385{\pm}3.8$ IU / mL) were significantly improved (p < 0.01). Conclusions: In spite of the limitation of the clinical trial protocol, this study may provide the possibility of natural environment-based therapy for children with atopic dermatitis.

Pilot Study: Effects of Acupuncture on the Muscle Cramps of Liver Cirrhosis Patients

  • Kim, Seung-mo;Kwak, Min-ah;Joo, Jeong-hyun;Kim, Kyung-soon;Shin, Im-hee;Lee, Chang-hyeong
    • 대한한방내과학회지
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    • 제39권3호
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    • pp.293-301
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    • 2018
  • Objective: The purpose of this clinical trial is to examine the efficacy and safety of electroacupuncture on liver cirrhosis patients suffering from muscle cramps. Methods: A total of 14 liver cirrhosis patients with muscle cramps were treated by electroacupuncture three times a week for four weeks (12 times total). The electrical stimulation was a frequency of 100 Hz. Evaluation of the muscle cramps was measured by a questionnaire of subjective symptoms. The patients' condition was evaluated four times over a period of eight weeks. We also assessed the deterioration of liver disease using the Child-Pugh score and blood tests. Results: This study proves that four weeks of electroacupuncture treatment is effective in reducing the frequency of muscle cramps and that the effects of electroacupuncture treatment lasted during another four-week follow-up period after treatment. Conclusions: This study suggests that electroacupuncture treatment is beneficial for improving muscle cramps in liver cirrhosis patients (p=0.000). Electroacupuncture is thought to be a safe treatment for liver cirrhosis patients with muscle cramps without contributing to the worsening of liver function. Further study with a larger sample size is needed to confirm our findings.

중풍 환자의 하지 경직에 대한 자하거 약침의 효과 연구 (The effect of Hominis Placenta Pharmacopuncture on Leg spasticity of stroke patients (A Pilot study, Double blind, Randomized, Controlled Clinical Trial))

  • 노주환;박정아;윤현민;장경전;송춘호;안창범;김철홍
    • 대한약침학회지
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    • 제12권4호
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    • pp.97-110
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    • 2009
  • Objective : The purpose of this study is to determine the effect of Hominis Placenta Pharmacopuncture(HPP) on lower limb spasticity control in stroke patients. Methods : Twenty stroke patients with Leg spasticity were randomly divided into two groups, a Distilled water Pharmacopuncture(group I) and a HPP(group II). The number of Pharmacopuncture was 5 times a week and acupuncture treatment was 3 times a week for 3 weeks. Modified Ashworth Scale(MAS), H-reflex/M-response ratio(H/M ratio), Berg Balance Scale(BBS) and Time Up & Go(TUG) were used for evaluation of spasticity control before experiment, after 1 week, 2 weeks, 3 weeks. Results : Group I showed significant improvement(p$<$.05) in BBS but no significant improvement in MAS, H/M ratio, and TUG. Group II showed significant improvement(p$<$.05) in MAS, BBS, and TUG, but no significant improvement in H/M ratio. The results showed significant difference in TUG, but no significant difference in MAS, H/M ratio and BBS between 2 groups. Conclusion : These results showed that HPP might decrease lower limb spasticity and increase leg motor function in stroke patients. Further studies will be required to examine more cases in the long period for the effect on lower limb in spasticity by HPP.

무작위 대조 시험을 통한 족관절 염좌의 자침 중 심자와 천자의 비교 연구-준비 조사 (Comparison of Superficial and Deep Acupuncture in the Treatment of Ankle sprain : A Randomized Controlled Trial-Pilot study)

  • 박준성;김우영;백승태;이승덕;김갑성
    • Journal of Acupuncture Research
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    • 제21권5호
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    • pp.137-147
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    • 2004
  • Objective : The aim of the study was to compare the therapeutic effect of the superficial and in-depth insertion of acupuncture needles in the treatment of patients with ankle sprain. Design : A prospective randomized single-blind study of superficial and deep acupuncture was conducted. Setting : The study was conducted in the Kang-nam Oriental Hosp. of Dong-Guk University. Patients: The study comprised 14 patients with ankle sprain who were divided into two groups (A and B). Intervention : In group A, the needle was introduced in the skin at a depth of 2 mm, whereas in group B the needle was placed deeply into muscular tissue or the articular capsule at a depth more than 1.5 Cm The treatment was planned for a duration of 1 week, 3 times. Outcome Measures : The intensity of pain was evaluated with the Ankle grade pain chart(AGPC) before and after treatment and at the 1-week follow-up examination. The AGPC includes Swelling, Tenderness, Exudation, Bruise, Medial/Lateral. stability test, Anterior drawer test, Squeeze test, Bearing weight, Pressure Algometer, Walking state and VAS. Results : Although at the end of the treatment there was no evidence of significant statistical differences between the two different groups, Pain reduction(VAS) was greater in the group treated with deep acupuncture. A statistical difference existed between the two groups at the 1 week follow up, with a better result in the deeply stimulated group in VAS. Conclusion : Clinical results show that deep stimulation has a better analgesic effect when compared with superficial stimulation in pain reduction(VAS, Visual analogic scale).

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마황복용이 정상성인의 체중 감소와 심박변이도에 미치는 영향에 관한 예비 연구: 무작위배정 이중맹검시험 (Effects of Ephedra on Weight Loss and Heart Rate Variability: A Double-Blind Randomized Controlled Pilot Study)

  • 양창섭;형례창;여진주;서의석;장인수
    • 대한한방내과학회지
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    • 제27권4호
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    • pp.836-844
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    • 2006
  • Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

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Effects of Catgut -Embedding Therapy in Patients with Carpal Tunnel Syndrome: a Retrospective Pilot Study

  • You, Kyung-Gon;Kwon, Young-Dal
    • 대한한의학회지
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    • 제36권2호
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    • pp.43-49
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    • 2015
  • Objectives: We evaluated the effect of the traditional Korean medical therapy of catgut-embedding therapy in patients with carpal tunnel syndrome (CTS). Methods: Thirteen patients(20 hands) with CTS underwent catgut-embedding therapy once per week for a total of 1-4 sessions. We measured the time to tingling in the fingers on performing Phalen's test. We also had patients use a visual analog scale (VAS) to indicate the severity of tingling. We also asked about the awakening time at night due to pain and tingling. We controlled the treatment as being limited to four sessions. Even if a patient had not been treated for four sessions, we ended the patient's treatment if symptoms resolved. Results: Patients who received catgut-embedding therapy showed significant improvements in the clinical symptoms of CTS. After treatment, in a total of 19 hands, the status of fourteen was changed from positive to negative in Phalen's test and the average of tingling occurrence time in that test was delayed. Among the 20 hands, the VAS in eight hands changed to zero and the average of VAS score decreased. Furthermore, in nine patients, four could sleep well without the use of a splint. Conclusions: Patients undergoing this traditional Korean medical therapy showed alleviation of finger tingling after even a single treatment. We thus concluded that this traditional Korean catgut-embedding therapy, may be effective for treating CTS. However, to confirm the effects of catgut-embedding therapy on CTS, further tests are required, including under the defined, strict conditions of a randomized controlled trial.

Efficacy of Roux-en-Y Reconstruction Using Two Circular Staplers after Subtotal Gastrectomy: Results from a Pilot Study Comparing with Billroth-I Reconstruction

  • Kim, Tae-Gyun;Hur, Hoon;Ahn, Chang-Wook;Xuan, Yi;Cho, Yong-Kwan;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • 제11권4호
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    • pp.219-224
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    • 2011
  • Purpose: The Roux en Y method has rarely been performed due to longer operation time and high risk of complication, despite several merits including prevention of bile reflux. We conducted a retrospective review of the result of Roux en Y reconstruction using two circular staplers after subtotal gastrectomy. Materials and Methods: From December 2008 to May 2009, a total of 26 patients underwent Roux en Y reconstruction using two circular staplers after subtotal gastrectomy, and seventy-two patients underwent Billroth-I reconstruction. Roux en Y anastomosis was performed using two circular staplers without hand sewing anastomosis. We compared clinicopathologic features and surgical outcomes between the two groups. All patients underwent gastrofiberscopy between six and twelve months after surgery to compare the bile reflux. Results: No significant differences in clinicopathologic findings were observed between the two groups, except for the rate of minimal invasive surgery (P=0.004) and cancer stage (P=0.002). No differences in the rate of morbidity (P=0.353) and admission duration (P=0.391) were observed between the two groups. Gastrofiberscopic findings showed a significant reduction of bile reflux in the remnant stomach in the Roux en Y group (P=0.019). Conclusions: When compared with Billroth-I reconstruction, Roux en Y reconstruction using the double stapler technique was found to reduce bile reflux in the remnant stomach without increasing postoperative morbidity. Based on these results, we planned to begin a randomized controlled clinical trial for comparison of Roux en Y reconstruction using this method with Billroth-I anastomosis.

Comparison of postoperative pain intensity after using reciprocating and continuous rotary glide path systems: a randomized clinical trial

  • Adiguzel, Mehmet;Yilmaz, Koray;Tufenkci, Pelin
    • Restorative Dentistry and Endodontics
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    • 제44권1호
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    • pp.9.1-9.9
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    • 2019
  • Objectives: The aim of this study was to compare postoperative pain intensity after root canal treatment with One G (OG) vs. R-Pilot (RP) files used for glide path preparation. Materials and Methods: Ninety-three single-canaled mandibular premolar teeth with asymptomatic non-vital pulp were randomly assigned into 3 groups (n = 31): OG, RP, or without glide path (WGP). After creating the glide path, the root canals were prepared using sequential Mtwo rotary files to size 30/0.05. One endodontic specialist carried out single-visit endodontic treatment. The patients were asked to rate the severity of postoperative pain on a visual analogue scale at 24, 48, and 72 hours after the visit. They were also asked to record their intake of prescribed analgesics taken. The data were analyzed using the ${\chi}^2$, Friedman, Kruskal-Wallis, and Mann-Whitney U tests. Results: In all 3 groups, postoperative pain decreased significantly at each time interval (p < 0.05). At 24 hours, the OG group had less postoperative pain than the WGP group (p < 0.05). However, no significant difference was found between the RP group and the others. No statistically significant difference was found among the WGP, OG, and RP groups in postoperative pain intensity at 48 or 72 hours or in analgesic tablet intake at the 3 assessed time intervals. Conclusions: The OG group had less postoperative pain than the WGP group in the first 24 hours. The OG and RP systems were similar regarding postoperative pain intensity and analgesic intake.