跳至主要内容
临床试验/CTRI/2025/02/080269
CTRI/2025/02/080269招募中Phase 3 4

A randomized, double-blind, active controlled, parallel-group, clinical study to evaluate the efficacy and safety of poly herb gel in treatment of clinically diagnosed stage I and Stage II Oral Sub Mucous Fibrosis.

Group Pharmaceuticals Ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月20日

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
1. The mean improvement in interincisal mouth opening

研究概览

简要总结

There is multi drug concept in treating OSMF and use of steroids will have long term disadvantage. Disadvantage of intralesional injections can form more fibrous bands, mucosal atrophy, difficulty to deposit sufficient quantities into gingival lesions, injection are painful and intrusive.  Herbal medicine has been used for thousands of years to treat a variety of health issues. It’s generally gentler on the body and has fewer side effects than prescription drugs, and it can also be more affordable. The  World Health Organization guidelines define herbal  medicines as finished, labeled medicinal products containing an active ingredient, i.e.,  obtained from the aerial or underground parts of botanicals or other plant materials or  their combination.4   Hence using poly herb has medicinal or rasaya properties provide a synergestic effect in the treatment. It is also safer and more potent in long term. Starting a poly herbal gel improves prognosis of the disease

研究设计

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

入排标准

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

入选标准

  • Adult patient who are clinically diagnosed with OSMF aged between 18 to 65 years
  • OSMF with grade I, and II will be included without any underlying comorbidities
  • Patients who are ready to quit the habit of betel quid/ areca nut/ gutkha chewing and are willing for regular follow-ups.
  • Must be willing and able to give informed consent and comply with the study procedures.

排除标准

  • Debilitating diseases such as carcinoma.
  • Patients contraindicated for steroids.
  • Patients with other mucosal disorders with clinical features same as OSF (such as: trismus due to Temporomandibular Joint Dysfunction, pericoronitis, space infection, history of surgery or trauma, systemic sclerosis, amyloidosis, iron deficiency anemia, radiation therapy).
  • Patients who were under treatment or have had already undergone treatment for OSF.
  • The patients with history of hypersensitivity to hyaluronidase.
  • Patients with history of hypersensitivity to herbal drugs
  • Patients with OSMF of Grade III and IV
  • Pregnant and lactating mothers.
  • Disease is most advanced with premalignant and malignant changes.

结局指标

主要结局

1. The mean improvement in interincisal mouth opening

时间窗: Day 0 Day 30 Day 60 and Day 90

2.The mean improvement in cheek flexibility

时间窗: Day 0 Day 30 Day 60 and Day 90

3.The mean improvement in tongue protrusion

时间窗: Day 0 Day 30 Day 60 and Day 90

次要结局

  • 1. Pain VAS(2. OSMF questionnaire)
  • Salivary Biomarkers (SImmunoglobulins)(Haematology Biochemistry)

研究者

发起方
Group Pharmaceuticals Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr G Roopashri

M R Ambedkar medical college and Hospital

研究点 (1)

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