An Open-Label, Single-Arm, Single-Center Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Gut Arogya in Subjects with Acidity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Brief Summary:
This study aims to evaluate the safety, tolerability, and effectiveness of Gut Arogya, an Ayurvedic formulation, in adults with mild-to-moderate gut acidity (Amlapitta/functional dyspepsia). Approximately 20 participants with a history of recurring acidity for at least 6 months will receive Gut Arogya daily for 30 days. Participants’ symptoms, quality of life, and overall tolerability will be monitored at baseline, Day 15, and Day 30.
Purpose of the Study:
The primary objective is to determine whether Gut Arogya reduces symptoms such as heartburn, bloating, belching, nausea, and early satiety. Secondary objectives include assessing quality of life improvements, safety, tolerability, and treatment compliance, and generating preliminary data for future larger trials.
Result of the study:
This Phase III, open-label, single-arm clinical study demonstrated that Gut Arogya provided meaningful clinical improvement in adults with mild-to-moderate acidity (Amlapitta/functional dyspepsia) over a 30-day treatment period. The primary objectives of the study were successfully met, with participants experiencing a clear reduction in the severity of acidity-related symptoms, as assessed by the Numeric Rating Scale (NRS), along with a notable decrease in the frequency of symptomatic episodes recorded in participant diaries. In addition, clinically meaningful improvements were observed in associated digestive complaints, including gas, constipation, and bloating, indicating broader gastrointestinal symptom relief and improved digestive function. Secondary outcomes further supported the therapeutic benefit of Gut Arogya. Quality of life, measured using the WHOQOL-BREF questionnaire, showed improvement across multiple domains, reflecting enhanced physical, psychological, and environmental well-being, while social health remained stable throughout the study period.
Gut Arogya was well tolerated, with both participant-reported outcomes and investigator assessments confirming good overall acceptability. No serious adverse events were reported, and all observed adverse events were mild, transient, and resolved without medical intervention, supporting a favorable safety profile. High treatment compliance throughout the study reinforced the feasibility and acceptability of daily administration.
In summary, Gut Arogya appears to be a safe, effective, and well-tolerated therapeutic option for the management of mild-to-moderate acidity and related digestive disturbances. By reducing symptom severity and frequency, alleviating associated gastrointestinal symptoms such as gas, constipation, and bloating, and improving overall quality of life, Gut Arogya demonstrates potential as a reliable intervention for comprehensive digestive health management.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, aged 18 to y70ears.
- •History of mild-to-moderate acidity (functional dyspepsia-like symptoms) for at least 6 months prior to screening.
- •Presence of one or more of the following symptoms within the past 7 days prior to screening:.
- •Epigastric burning/pain.
- •Heartburn or retrosternal burning.
- •Belching/eructation.
- •Early satiety.
- •Nausea and/or vomiting.
- •Flatulence/gas discomfort
- •Willingness and ability to comply with all study procedures, including daily symptom diaries and study visits.
- •Signed and dated informed consent obtained prior to any study-related procedure.
- •For females of childbearing potential: agreement to use acceptable contraception throughout the study.
排除标准
- •Known history or current evidence of serious systemic disease, including:.
- •Tuberculosis, HIV, HBV, or HCV infection.
- •Ischemic heart disease, malignancy, chronic renal failure, or chronic liver disease.
- •Jaundice or clinical evidence of active hepatitis
- •Diagnosis of other functional gastrointestinal disorders (IBS, chronic constipation, ulcer disease, GERD requiring PPI therapy).
- •Presence of diabetes mellitus or hypertension requiring daily medication.
- •Use of any investigational product within 30 days prior to enrollment.
- •Use of prohibited concomitant medications (PPIs, H2 blockers, prokinetics, antibiotics, bismuth salts, NSAIDs, herbal GI remedies) within 7 days prior to baseline.
- •Known allergy, hypersensitivity, or intolerance to any of the components of Gut Arogya.
- •Pregnant or lactating women.
- •Clinically significant laboratory abnormalities (if tested) or any other medical or psychiatric condition that, in the opinion of the Investigator, would make participation unsafe or interfere with study outcomes.
研究者
Dr Indushree B S
RVS Ayurvedic Medical College Hospital and Research Centre