Evaluation of the comparative efficacy of Polyherbal syrup versus Ondansetron syrup in the management of Chhardi(vomiting) in children: A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Polyherbal Syrup in the management of chhardi in children of age 1 year to 18 years with objective and subjective criteria
研究概览
简要总结
The volunteers will be informed about the study protocol. Willing participants will be randomly selected from per computer-generated table. The clinical research format will be prepared and validated. Before the study approval is 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 the selection criteria. They are divided into two groups. The trial is a Randomized, double-blind, equivalence Clinical Trial. Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and 14th day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Written informed Consent and ascent will be obtain 2)Age 1 year to 18 years 3)3 or more than 3 episodes of vomiting in 24 hours 4)Mild to moderate dehydration 5)Associated diarrhea patients will also be included.
排除标准
- •Moderate to Severe infection and dehydration or shock 2)Any Chronic systemic illness 3)Antiemetic use in the past 24 hours 4)Allergy to any formulation ingredient 5)Fever more than 100 degree fahrenheit 6)Abuse, poison or suspicious case 7)Congenital anomalies and Metabolic syndrome 8)Participants did not receive the Antihelminthic drug.
结局指标
主要结局
To assess the efficacy of Polyherbal Syrup in the management of chhardi in children of age 1 year to 18 years with objective and subjective criteria
时间窗: Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and | 14th day
次要结局
- To assess the efficacy of Ondansetron Syrup in the management of chhardi in children with objective and subjective criteria.(Assessment daily for 5 days and post-treatment follow-up on 7th,10th, and)
研究者
DR DHANANJAY BHAGWAN MORE
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha