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临床试验/NCT01429935
NCT01429935Unknown2 期

Comparison of The Anti Inflammatory and Analgesic Effect of Ginger and Ibuprofen in Post Surgical Pain Model; a Randomized,Placebo-controlled,Double-blind Clinical Trial

Qazvin University Of Medical Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
试验地点
2
主要终点
Decreased amount of cheek swelling after surgery

研究概览

简要总结

Ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory components, its efficacy on acute inflammation was not assessed before. The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce postoperative swelling, pain and trismus in an acute pain model.

详细描述

Ginger, the rhizome of Zingiber officinale, has a long history of medicinal use. In traditional Chinese and Indian medicine, ginger has been used to treat a wide range of ailments including stomachache, diarrhea, nausea, asthma, respiratory disorders, toothache, gingivitis, and arthritis. Subsequent studies revealed that ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Different animal studies revealed that oral dried ginger or ginger extract reduced inflammation in paw and joint swelling induced by different chemical agents, lung inflammation induced by lipopolysaccharides (LPS) and arthritis induced by collagen . Several clinical studies support the value of ginger for the treatment of osteoarthritis . In addition to alleviating pain, ginger extract has been reported to decrease joint swelling. In some of these trials it was reported that ginger relieved pain and swelling to varying degrees in patients with osteoarthritis and rheumatoid arthritis as well as those with muscular pain without causing any adverse effects during a period ranging from 3 months to 2.5 years . In one recent trial ginger was tested in primary dysmenorrhea in comparison with Ibuprofen and mefenamic acid and no significant differences was found between the three study groups in relief, stability, or aggravation of symptoms . The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials . However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru,Iran) to reduce postoperative swelling, pain and trismus after third molar surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Have at least one mesio-angular impacted mandibular third molar(5-7 difficulty degree)
  • adults without any kind of systemic disease
  • adults with at least Diploma educational degree

排除标准

  • history of cold,fever,infection or any other inflammatory conditions during one month before surgery
  • known allergy to NSAIDs ,ginger or acetaminophen
  • any kind of hematopoietic or bleeding disorders
  • pregnancy or lactating
  • history of peptic ulceration
  • history of corticosteroid use
  • duration of surgery more than 30 minutes
  • any infection, fever or any kind of disease cause on days 1,2 and 3 after surgery
  • failure to attend for follow up
  • using any kind of medication other than given drugs until day 5 post operatively
  • being on anticoagulants except for mini-aspirin (72-325 mg/day)
  • mentally incapable of understanding or complying with the study protocol or for failing to sign the informed consent

研究组 & 干预措施

Ginger powder

Active Comparator

干预措施: Ginger powder (Drug)

Ibuprofen

Active Comparator

capsules of Ibuprofen 400 mg

干预措施: Ibuprofen (Drug)

placebo

Placebo Comparator

capsules contain starch

干预措施: placebo (Other)

结局指标

主要结局

Decreased amount of cheek swelling after surgery

时间窗: 5 days

Using standard calipers, cheek thickness will be measured from the lingual aspect of the mid-portion of the crown of the mandibular 1st molar (on the same side) to the tangent of the skin of the cheek.

次要结局

  • Decreased amount of serum CRP levels(3 days)
  • Amount of pain severity(5 days)
  • Increased amount of Mouth opening ability(5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

farshid rayati

assisstant proffessor of oral and maxillofacial department

Qazvin University Of Medical Sciences

研究点 (2)

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