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临床试验/CTRI/2025/03/082204
CTRI/2025/03/082204尚未招募不适用

to assesss and compare the efficacy of willow bark extract with ibuprofen for patients with acute pulpal pain -a randomized placebo controlled double blinded clinical trial

未提供1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年4月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
assess efficacy of Willow bark extract and compare with ibubrufen

研究概览

简要总结

Odontogenic pain refers to pain initiating from the teeth or their supporting structures, the mucosa, gingivae, maxilla, mandible or periodontal membrane. The overall pooled prevalence of toothache in children and adolescents was 36.2% and   patients with dental caries have 3.49 times more chance of reporting toothache according to literature. Evidence gathered from studies and the work of others appears to support the presence of two distinct nerve pain pathways in the dental pulp, represented by fast conducting A-delta and slow conducting C-fibers. Each of these types of fibers has different pain characteristics: A-delta fibers evoke a rapid, sharp, lancinating pain reaction, and C-fibers cause a slow, dull, crawling pain. Usually for management of odontogenic pain, Non Steroidal Anti-inflammatory drugs (NSAIDS) are prescribed which   decrease the production of prostaglandins thereby decreasing the intensity of pain. Most commonly prescribed are ibuprofen (400 mg ) , naproxen (500 mg),Aspirin (600 mg) .Although NSAIDs are safe if used for a short period of time, they may cause heartburn, nausea, vomiting, diarrhea, and in some cases potentially serious adverse effects such as gastric ulcer gastric perforation , and  cardiovascular risks. Hence ,there is a need for alternative medicinal therapy. One such safer method is Phytotherapy (Herbal medicine).So, these emerging trends can meet the changing demands of the patients. Herbal medicines are safe , since they are found in nature, such remedies are assumed to be safer than NSAIDs. Furthermore, the value of many of the herbs has been celebrated throughout ages, without any mention of detrimental side effects. One of the modern advances in herbal therapy is the use of willow bark (Salix Alba). The chemical oxidation of salicin, a known constituent of the bark of the willow tree (Latin name: Salix), resulted in a new substance termed ‘salicylic acid’, and the acetylated derivative of this substance eventually turned into one of the most successful drugs in history, Aspirin. According to the literature 240 mg salicin/day will produce no more than115mg of salicylic acid and would therefore not be expected to produce analgesic or anti-inflammatory action of salicylic acid. However, Willow bark extract has been used in required amount because of its anti-inflammatory, antianalgesic, and antipyretic action in few earlier studies .

研究设计

研究类型
Observational

入排标准

年龄范围
16.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • (1) Patient who are willing to participate in the study.
  • (2) Patients of age between 16 and 45 years.
  • (3) Patients with Dental caries with Acute pulpal pain.

排除标准

  • (1)History of any allergic reaction to herbal preparations.
  • (2) Pregnancy & Lactating women (3)Patients with gastric irritation and any other systemic illness and undergoing treatment for the same.
  • (4) Patients with other orofacial pain and swelling.
  • (5) Patients with involvement of acute pulpal pain in multiple teeth.

结局指标

主要结局

assess efficacy of Willow bark extract and compare with ibubrufen

时间窗: pain score noted after 6 hours

次要结局

  • compare the efficacy of willow bark to that of ibuprofen(at the end of 2nd month)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

BVINU PRIYA

SRM

研究点 (1)

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