An Open, Randomized, Comparative Clinical Study of Dhanyakadi Churna and Panchnimbadi Churna in the Management of Urdhwag Amlapitta
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Utklesha
研究概览
简要总结
The primary objective of this open, randomized, comparative clinical study is to evaluate and compare the efficacy of Dhanyakadi Churna and Panchnimbadi Churna in the management of Urdhwag Amlapitta, a condition in Ayurveda correlating with gastroesophageal reflux disease (GERD), characterized by symptoms such as indigestion, nausea, sour belching, burning sensations in the chest and throat, and fatigue. Rooted in Ayurvedic principles, Urdhwag Amlapitta is believed to arise from the vitiation of Pitta dosha due to lifestyle and dietary factors. This clinical trial includes 62 patients, randomly assigned into two groups (31 each), with both groups receiving their respective churna at a dose of 3 grams twice daily for 21 days, administered with honey. The primary hypothesis posits that both formulations are equally effective in treating Urdhwag Amlapitta, while secondary hypotheses explore whether one treatment demonstrates superior efficacy over the other. The study seeks to provide scientific evidence for the use of these Ayurvedic formulations as viable alternatives to conventional pharmacological treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Age 18 to 60 years Gender All genders Symptoms Urdhwag Amlapitta Hrit Kantha Dah, Tikt Amlodgar, Utklesha, Avipak, Aruchi, Klama.
- •Compliance Patients who are willing and able to adhere to the study protocol, including prescribed treatments and follow-up schedules.
- •Health Status Patients with no significant comorbidities that could interfere with the Study outcomes or the safety of the participant, as determined by a clinical assessment.
- •Medication History Patients who have not used any other Ayurvedic or allopathic treatments for Urdhwag Amlapitta in the past two weeks.
排除标准
- •Pregnancy and Lactation Psychiatric Disorders Chronic or Severe Medical Conditions Recent Surgery Current Use of Confounding Medications Substance Abuse Participation in Other Trial.
结局指标
主要结局
Utklesha
时间窗: 3 weeks
Avipak
时间窗: 3 weeks
Hrit Kantha daha
时间窗: 3 weeks
Tikta amlodgar
时间窗: 3 weeks
Aruchi
时间窗: 3 weeks
Klama
时间窗: 3 weeks
次要结局
未报告次要终点