Efficacy of a structured Pathya Ahara Regimen and Yashtimadhu Hima in the Management of Amlapitta: an open labels comparative study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Amlapitta is a commonly encountered gastrointestinal disorder described in Ayurveda, characterized by symptoms such as heartburn, sour belching, nausea, indigestion, and epigastric discomfort. Improper dietary habits, intake of incompatible food, and unhealthy lifestyle practices play a significant role in its pathogenesis. Conventional treatment often provides symptomatic relief with frequent recurrence, highlighting the need for safe and effective Ayurvedic interventions.
Ayurveda emphasizes Pathya Ahara as a primary line of management in Amlapitta. Yashtimadhu (Glycyrrhiza glabra), due to its Madhura rasa, Sheeta veerya, and Pitta-shamaka properties, is traditionally used in the management of Amlapitta, especially in the form of Hima.
The present study is planned as an open-label, comparative clinical trial to evaluate the efficacy of a structured Pathya Ahara regimen and Yashtimadhu Hima in the management of Amlapitta. Eligible patients will be allotted into two separate groups. One group will receive a structured Pathya Ahara regimen, while the other group will receive Yashtimadhu Hima alone for a defined treatment period.
The efficacy of the interventions will be assessed based on improvement in subjective clinical parameters such as heartburn, sour regurgitation, nausea, indigestion, and epigastric pain. The study aims to compare the individual therapeutic effects of Pathya Ahara and Yashtimadhu Hima in the management of Amlapitta.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult patients aged 18–60 years irrespective of sex religion or caste 2 Presence of classical sign and symptoms of amlapitta 3 Duration of Amlapitta symptoms less than 6 months.
- •Patients who provide informed consent and Inclusion in Group A (Structured Pathya Ahara Regimen) or Group B (Yashtimadhu Hima) will be based on the clinical indication and suitability of the intervention for that particular patient as assessed by the investigator.
排除标准
- •Known case of gastric and duodenal ulcer , gastric carcinoma.
- •Patients testing positive for Helicobacter pylori.
- •Patients with a history of cardiovascular disease or uncontrolled hypertension (systolic equal to and greater than 160 mmHg, diastolic equal to and greater than 100 mmHg despite medication), Renal impairment (Sr. creatinine greater than 1.2 mg/dl), Hepatic impairment (SGOT and SGPT greater than three times the upper limit), uncontrolled diabetes (HbA1c greater than 7.0 percent).
- •Subjects with comorbidities such as Tuberculosis, immunocompromised states such as HIV, history or active malignancy etc.
- •Patient on systemic or oral steroids for more than 1 year.
- •Pregnant women and lactating mother.
- •Patients with congenital anomalies, prior major gastrointestinal surgery.
- •Patients currently under treatment for psychiatric disorders.
- •Patients who have participated in any clinical trial in the past 6 months.
研究者
Sagar Rahangdale
Ayurvedic and Unani Tibbia College and Hospital ,karol bagh delhi 110005