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临床试验/CTRI/2025/08/093407
CTRI/2025/08/093407尚未招募2/3 期

TO EVALUATE THE EFFICACY OF POLYHERBAL UNANI FORMULATIONS IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS OPEN LABEL INTERVENTIONAL CLINICAL TRIAL MANAGEMENT OF ORAL SUB-MUCOUS FIBROSIS OPEN LABEL INTERVENTIONAL CLINICAL TRIAL

State Unani Medical College and HAHRDM hospital1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
43
试验地点
1
主要终点
LIKERT scale

研究概览

简要总结

Oral Sub Mucous Fibrosis is a chronic condition of the oral cavity characterized by inflammation and fibrosis in the mucosa and submucosa leading to mouth rigidity and difficulty opening the mouth Symptoms include a burning sensation intolerance to spicy foods ulcers and loss of taste The primary cause is the habitual chewing of areca nut betel nut often combined with tobacco though other factors like excessive spice consumption smoking and genetic predisposition also contribute

OSMF has a high morbidity rate due to eating difficulties and nutritional deficiencies and it can lead to oral cancer often progressing from lesions like leukoplakia or OSMF itself In India approximately twenty three point nine percent of the adult population consumes areca nut with a high prevalence of oral malignancies linked to this habit

Current treatment includes nutritional support physiotherapy steroids and surgical interventions though these are often limited in effectiveness and have side effects There is growing interest in herbal treatments with a focus on Khamira Banafsha and Barg i Rehan Sabz in Unani medicine as potential alternatives for managing OSMF Despite existing treatments recurrence remains common highlighting the need for more effective and holistic solutions

Hence this study is planned with a holistic Unani approach to evaluate the efficacy of Khamira banafsha and Barg i Rehan sabz in the management of OSMF

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • The patients having clinical signs and symptoms of OSMF with a documented history of consuming chewing tobacco areca nut pan masala or gutka as the primary etiological factor scoring 6 or below based on the classification given by SK Katharia37 The patients willing to give written informed consent to do protocol follow up.

排除标准

  • Extensive fibrosis and or with severe trismus with an Inter Incisal Distance less than or equal to 17mm Disease is most advanced with known malignant changes Patients on any treatment for OSMF In case they are then such a treatment would be stopped and a washout period of 2 weeks would be given Pale oral mucosa of anemia mimicking blanching Pregnancy lactation Chronic debilitating conditions such as DM HTN HIV Hepatitis B bleeding disorders cardiovascular diseases renal dysfunction liver disorders mucosal disease or any other skin lesions and a known allergy or contraindication to the study drug Patients not willing to give up addiction habits of Gutka Pan Masala tobacco.

结局指标

主要结局

LIKERT scale

时间窗: 0 3 6 9 and 12 weeks

VAS scale

时间窗: 0 3 6 9 and 12 weeks

次要结局

  • IID Inter Incisal Distance(0 3 6 9 and 12 weeks)

研究者

发起方
State Unani Medical College and HAHRDM hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Alisha Adil

State Unani Medical college and HAHRDM hospital

研究点 (1)

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