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临床试验/CTRI/2025/12/098415
CTRI/2025/12/098415尚未招募3 期

Efficacy of ‘Nimbamrutham’ Herbal Mouthwash in Prevention and Management of Concurrent Chemo-Radiotherapy Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Trial.

Dr Anchu T M1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年12月15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
132
试验地点
1

研究概览

简要总结

Head and neck cancer patients who receive concurrent chemo radiotherapy often develop oral mucositis. This is a painful inflammation and ulceration of the mouth that affects eating, swallowing, sleep, nutrition, and overall quality of life. Severe mucositis may lead to treatment breaks, infections, increased hospital stay and higher treatment costs. At present, commonly used management methods such as soda saline mouthwash and symptomatic medicines provide only limited relief.

Ayurveda describes a similar condition called mukhapaka and recommends local treatments such as herbal gargling. Nimbamrutham is a traditional Ayurvedic preparation made from neem and guduchi. These herbs are known for their antimicrobial, anti inflammatory and healing properties. This study aims to evaluate the effect of Nimbamrutham mouthwash in patients undergoing chemo radiotherapy.

In this randomized study, patients will be divided into two groups. One group will use the routine soda saline mouthwash and the other group will use Nimbamrutham mouthwash. Both groups will perform gargling four to six times daily from the first day of radiation. The severity of oral mucositis will be assessed every week using the RTOG grading system. The study aims to find out whether Nimbamrutham can reduce the severity of mucositis and improve patient comfort during treatment.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All head and neck cancer patients receiving radical radiotherapy /chemoradiotherapy to the oral cavity and oropharynx.
  • Patients between the age group of 18 to 70 years.
  • Patients willing to participate, after signing informed consent.

排除标准

  • Palliative radiotherapy.
  • Patients receiving radiation to sites other than oral mucosa.
  • Patients with associated complications such as chronic renal failure, hepatic disorders, and mental confusion.

研究者

发起方
Dr Anchu T M
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rejnish Kumar R

Regional cancer centre Thiruvananthapuram

研究点 (1)

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