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临床试验/NCT06269406
NCT06269406尚未招募不适用

A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults, Randomized, Double- Blind, Parallel-Group, Placebo-Controlled Study

S.LAB (SOLOWAYS)2 个研究点 分布在 2 个国家目标入组 264 人开始时间: 2025年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
264
试验地点
2
主要终点
Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)

研究概览

简要总结

Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Removal of 2 to 4 impacted third molars

排除标准

  • Pregnancy or breastfeeding
  • Ibuprofen contraindications.
  • Allergy to any of the intervention components.

研究组 & 干预措施

Intervention Group ibuprofen 400 and Curcumin

Experimental

干预措施: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg (Dietary Supplement)

Intervention Group ibuprofen 200 and Curcumin

Experimental

干预措施: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg (Dietary Supplement)

Intervention Group ibuprofen 400 and placebo

Placebo Comparator

干预措施: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure (Other)

结局指标

主要结局

Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)

时间窗: 8 hours

次要结局

  • Time to pain half pain gone (in minutes)(8 hours)
  • Duration of pain half gone (in minutes)(8 hours)
  • Any adverse events (facial swelling, nausea, vomiting, headache) (%)(8 hours)
  • Total pain relief (TOTPAR) %(8 hours)

研究者

发起方
S.LAB (SOLOWAYS)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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