Efficacy evaluation of Sharbat Toot Siyah in Waram-e-Lawzatayn haad (Acute Tonsillitis) in children: An open label interventional study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in clinical score and PGA
研究概览
简要总结
This study is being conducted to evaluate the effectiveness and safety of Sharbat Toot Siyah, a traditional herbal syrup made from black mulberries, in the treatment of acute tonsillitis in children. Forty patients between 5 and 15 years of age with mild to moderate tonsillitis will be enrolled in an open label interventional study. The intervention will be given for 14 days and patients will be assessed at baseline, day 7 and day 14. The main outcomes are change in clinical score and patient global assessment. Secondary outcomes include improvement in throat pain, fever, difficulty in swallowing, tonsil swelling, and lymph node tenderness. Safety will be assessed by routine laboratory investigations. The study hypothesis is that Sharbat Toot Siyah is effective in reducing the symptoms of acute tonsillitis in children.
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
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients of both genders 2 Patients in the age group of 5 and 15 years 3 Clinically diagnosed case waram e lawzatayn haad (acute tonsillitis) 4 Mild and moderate cases of waram e lawzatayn haad (acute tonsillitis) having clinical score less than equal to 8 5 Patients guardian or parents willing to sign the informed consent form and follow the study protocol.
排除标准
- •1 Patients below 5 years of age 2 Patients above 15 years of age 3 Patient with any complication of tonsillitis like peritonsillar abscess, otitis media, sinusitis 4 Tonsillitis associated with any other systemic, or chronic disease like TB, pneumonia, rheumatic fever, meningitis, toxic shock syndrome 5 Use of antibiotics or NSAIDs or Analgesics or Antipyretics or Antihistamine in the previous one week 6 Patient is unsure about attending schedule regularly.
结局指标
主要结局
Change in clinical score and PGA
时间窗: 14 days
次要结局
- Change in acute tonsillitis symptoms: enlarged tonsils, dysphagia, odynophagia, sore throat, fever, tender cervical lymph nodes.(14 days)
研究者
Dr Danish
State Unani Medical College