Evaluation of comparative efficacy of Trivritadi syrup versus Shunthyadi syrup in the management of Vibandha (Constipation) in children: A Randomised Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Trivritadi syrup over Bristol stool scale in children having Vibandha (Constipation)
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 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 the selection criteria. They are divided into two groups. The trial is a Randomized Double Blind Equivalence Standard Control Clinical Trial. It will include a 7-day treatment period and a follow up period during treatment on the 3rd, 5th, and 7th day and after treatment on 8th 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
- 5.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children whose parents are giving written consent for their child to participate in the study.
- •Patients from 5 years to 15 years of age suffering from vibandha irrespective of religion, race, gender, and socioeconomic condition.
- •Vibandha caused due to dosha and agni dushti or any other metabolic problems related to digestion like abdominal pain, distension, anorexia with a history of constipation in children.
- •Constipation grade between 2 to 3 on bristol stool scale.
排除标准
- •Patients requiring surgical management will be excluded.
- •Patients suffering from any known acute or chronic medical and surgical illness or a congenital anomaly of the anus and rectum will be excluded.
- •Known cases of chrons disease, hirschsprungs disease, tb, hiv and malignancies will be excluded.
结局指标
主要结局
To assess the efficacy of Trivritadi syrup over Bristol stool scale in children having Vibandha (Constipation)
时间窗: 7 Days
次要结局
- To assess the efficacy of Shunthyadi syrup over Bristol stool scale in children having Vibandha (Constipation)(7th and 14th Day)
研究者
DR ANIRUDDHA SANTOSHRAO UNHALE
Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha