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临床试验/CTRI/2025/09/095315
CTRI/2025/09/095315尚未招募3 期

Comparison Of the Efficacy Of Topical Sida Rhombifolia Extract And Topical Diclofenac Sodium In Management Of Temporomandibular Joint Pain Disorders: A Double Blinded Randomized Controlled Trial

Yesoda Aniyan K1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年10月4日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
46
试验地点
1
主要终点
To alleviate the pain associated with Temporomandibular joint disorders

研究概览

简要总结

To assess the phytochemical components and investigations for medicament preparation.

To determine the efficacy of topical Sida cordifolia in TMD using Numerical Rating Scale in pain management.

To compare the effectiveness of topical SC with topical Diclofenac Sodium in patients with TMD with or without associated masticatory muscle pain.

The primary objective of the study

To evaluate the comparative efficacy of topical  Sida cordifolia root extract to topical diclofenac sodium in the management of  TMD disorders associated masticatory muscle pain

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients who are willing for the study 2.Patients above 18 years of age 3.Patients with TMD with or without masticatory muscle pain under RDC criteria are included.
  • Patients with symptoms of pain along with clicking, crepitus,deviation during jaw movement, pain and difficulty in opening the mouth, pain in pre auricular area, and spreading to surrounding areas.

排除标准

  • Patients under 18 years of age
  • Pregnant and lactating patients
  • Physically challenged and mentally retarded persons
  • Patients with previous history of TMD and underwent treatment for it or on going currently.
  • Patients with clear history of swelling, trauma,fracture,intolerable pain in temporomandibular joint
  • Subjects with history of allergy to the drug components.

结局指标

主要结局

To alleviate the pain associated with Temporomandibular joint disorders

时间窗: Evaluate at 7,14,21 1nd 28days

次要结局

  • Efficacy of Sida Rhomifolia extract medicament in comparison to standard topical diclofenac sodium in pain management(0,7,14,21 and 28 days.)

研究者

发起方
Yesoda Aniyan K
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yesoda Aniyan K

SRM Dental College, Ramapuram

研究点 (1)

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