Evaluation of Comparative Efficacy of Modified Dosage form of Krushna Jeerkadi Yoga (Lotion) vs Mrudivkadi Lotion in Children with Stomatitis (Mukhapaka)- A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Relief from signs and symptoms of Stomatitis (Mukhapaka) as pain, irritability, burning sensation, excessive salivation.
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly
selected as per computer computer-generated table. The clinical research format will be prepared and validated.
Before the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI
registration will be done. After selection, each participant will be tested individually and selected
according to selection criteria. They are divided into two groups. The trial is a Randomized standard
Control Superiority Clinical Trial. it will include a 7-day treatment period and, after 7 days, follow-up
period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with classical signs and symptoms of Stomatitis, such as pain, irritability, ulceration, and excessive salivation.
- •Patients with a baseline severity score indicating mild to moderate Stomatitis on the WHO stomatitis grading scale
- •Whose Parents are willing to sign Written Informed Consent.
- •Patients will be included irrespective of age, gender, race, religion and socioeconomic status.
排除标准
- •Children with severe stomatitis require immediate intensive medical intervention.
- •Children who have received treatment for stomatitis within the last two weeks.
- •Families unwilling or unable to comply with study requirements.
- •Children with autoimmune conditions leading to stomatitis.
结局指标
主要结局
Relief from signs and symptoms of Stomatitis (Mukhapaka) as pain, irritability, burning sensation, excessive salivation.
时间窗: 7 Days
次要结局
- Oral intake will be increased(7-14 Days)
研究者
Dr Parag Rajendra Bodke
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha