Evaluation of the Comparative Efficacy of Ghanadi Lozenges versus Dextromethorphan Lozenges in the management of Vataj Kasa (Acute Cough) 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
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Ghanadi lozenges in the management of vataj kasa (acute cough ) based on 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 as per a 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 Control Clinical Trial.
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
- 6.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to participate in the study and give written informed assent 2)No previous treatment for the disorder 3)The participants aged 6 to 18, age either gender, with Kasa, who will be recruited from the pediatric institutional OPD 4)Children aged more than 5 years or older with symptoms of Kasa for less than 4 weeks.
排除标准
- •Children with a known case of respiratory problems like: Pneumonia, bronchial asthma, pleurisy, bronchiectasis, tuberculosis, malignancy Subjects with other systemic disorders and metabolic diseases.
结局指标
主要结局
To assess the efficacy of Ghanadi lozenges in the management of vataj kasa (acute cough ) based on objective and subjective criteria.
时间窗: Treatment daily for 7 days and post-treatment follow-up on the 14th and 60th day
次要结局
- To assess the efficacy of Dextromethorphan lozenges in the management of vataj kasa (acute cough ) based on objective and subjective criteria.(To assess the reduction in the frequency of cough)
研究者
DR NITESH SUBHASH LOKHANDE
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha