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临床试验/CTRI/2024/11/076330
CTRI/2024/11/076330尚未招募4 期

Evaluation of efficacy of Curcumin and Clove oil lozenges in comparison to topical triamcinolone acetonide paste in treatment of oral submucous fibrosis: A randomized control trial

Gelnova Laboratories India OPvt Ltd1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年11月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
1.Benefit in improvement of mouth opening

研究概览

简要总结

·     Oral submucous fibrosis (OSMF) is a chronic, inflammatory, and potentially malignant disorder of the oral cavity, and has been linked to the chewing of areca nut. Oral submucous fibrosis has a number of characteristic signs and symptoms, including gradual mouth narrowing, oral mucosal blanching, burning and discomfort while consuming food, hypomobility of the tongue and soft palate, diminished taste sensibility, and minor hearing impairment as a result of eustachian tube obstruction.

Polyphenols have antioxidant properties that make them important for both preventing and treating OSMF. Turmeric, an Indian golden spice, is a polyphenol that has long been known for its medicinal effects. From ancient times, curcumin, the active ingredient in turmeric, has been utilized extensively in India as a folk medicine for many diseases.It is used as an anti-inflammatory, antibacterial, antioxidant, anticancer agent towards treatment of inflammatory, immune mediated and potentially malignant lesions.

·    Clove (Syzygium aromaticum) is one of the most valuable spices that has been used for centuries as food preservative and for many medicinal purposes plant represents one of the richest sources of phenolic compounds such as eugenol, eugenol acetate and gallic acid and possess great potential for pharmaceutical, cosmetic and food applications. The spice contains a good amount of minerals like magnesium, manganese, potassium, iron, and selenium Antioxidants are compounds which are essential for the treatment of oxidative stress. Treatment with clove oil reduces oxidative stress mediated by reduced glutathione levels.

Clove oil and turmeric may provide a powerful combination for management of oxidative stress in OSMF and for improving its signs and symptoms. It may be a potential breakthrough in management of OSMF using indigenous, herbal products.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with OSMF clinically and histopathologically 2.Patients with age group: 18 yr.
  • 60yr 3.Patients with OSMF Stage II and Stage III (More et al classification 2011) 4: Patients who are not treated previously for OSMF.

排除标准

  • Patients with other mucosal lesions other than OSMF 2.Patients with trismus due to other reasons.
  • 3.Patients who are currently on any treatment for OSMF 4.Patients with co-existing systemic ailments.

结局指标

主要结局

1.Benefit in improvement of mouth opening

时间窗: 0, 15 days, 30 days 45 days and 60 days

2.Improvement of burning sensation

时间窗: 0, 15 days, 30 days 45 days and 60 days

次要结局

  • Enhancement of overall quality of life of the patient.(60 days)

研究者

发起方
Gelnova Laboratories India OPvt Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Richa Srivastava

DY Patil school of dentistry, Nerul, Navi Mumbai

研究点 (1)

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