A Multi-center, Open Label, Single Arm, Interventional Clinical Study to Assess the Efficacy of ENO Lime in Patients With Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, and Associated Nausea)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- HALEON
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 15 Minutes of Taking ENO Lime
研究概览
简要总结
The primary purpose of this study is to assess the efficacy of ENO Lime (fruit salt) in participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea) at 15-minutes after administration of dose. 'Ajeerna vyadhi' is defined as a state of incomplete digestion and metabolism caused due to deranged action of Jatharagni (digestive fire), which leads to the formation of an unprocessed or under-processed state of ingested food termed as Ajeerna.
详细描述
This will be an open label, single arm, interventional clinical study to evaluate the efficacy and safety of ENO Lime in adult participants with Ajeerna vyadhi (acidity, acid indigestion, indigestion, and associated nausea). The study will be conducted at three sites in India and approximately 40 participants will be enrolled. At baseline, the participants will record the severity of symptoms of Ajeerna vyadhi using the visual analogue scale (VAS) scoring before administering the ENO Lime. As per recommendation, the participants will consume the dose of the ENO Lime on-site and will record any changes in the severity of symptoms of Ajeerna vyadhi using VAS scoring at 2-minutes, 15-minutes, 1-hour, 2-hour post-dose. Participants will be permitted to take the second dose of the ENO Lime (only if required) after 2 hours of the first dose. In such cases, participants will be instructed to record symptoms of Ajeerna vyadhi again using the VAS scoring before taking the second dose (at 0 minutes) and then at 2-minutes, 15-minutes, 1-hour, and 2-hours post-second dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants with age 18-60 years (both inclusive).
- •Participants newly experiencing symptom/s of Ajeerna vyadhi for not more than 10 days.
- •Participants with at least one symptom of Ajeerna vyadhi (according to Charak Samhita and Madhav Nidan) that is acidity (heartburn), acid indigestion (epigastric pain), indigestion (abdominal discomfort), or associated nausea.
- •Participants with VAS score greater than or equal to (>=) 40-mm and less than or equal to (<=) 80-mm Ajeerna vyadhi (acidity, acid indigestion, indigestion, or associated nausea) at the Baseline visit.
- •Participants are able to read, understand, and provide written informed consent.
- •Participants who can understand and complete the VAS.
排除标准
- •Participants with chronic and recurrent cases of Ajeerna vyadhi.
- •Participants with Updrava of Ajeerna vyadhi (Complications of indigestion).
- •Pregnant women (self-reported) and breastfeeding females or females intending to become pregnant during the study.
- •Participant had surgery in the last 14 days.
- •Participant has been exposed to barium meal 3 days before screening.
- •Participants already on any indigestion or acidity medication.
- •Participants taking any medicinal/over-the-counter (OTC)/ herbal medicine from the past 3 days.
- •Participants on medications that could interact with ENO Lime (example, antacids, proton pump inhibitors, or H2 blockers) as per the judgment of the Investigator/designee.
- •Participants with known hypersensitivity to any of the components of ENO Lime (Svarjiksara [Shudh], Nimbu Rasa [Citrus limon, Fruit Juice Powder]).
- •Participants with a history of gastrointestinal (GI) disorders such as peptic ulcers, gastritis, irritable bowel syndrome (IBS), or other serious GI diseases.
- •Participants with serious renal, hepatic, or cardiovascular diseases.
- •Participants on a sodium restricted diet example, those suffering from hypertension or congestive heart failure.
- •Participants who have participated in another clinical trial within the last 30 days.
- •Any participant who, in the opinion of the investigator, should not participate in the study.
研究组 & 干预措施
ENO Lime
Participants will be instructed to take 1 sachet of ENO Lime powder with approximately 150 milliliters (ml) of normal water as a single dose. Participants will be advised to repeat the dose after 2-hours, if necessary (Maximum 2 sachet per 24-hours). Participants will be followed up for 24-hours.
干预措施: ENO Lime (Drug)
结局指标
主要结局
Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 15 Minutes of Taking ENO Lime
时间窗: Baseline (0-minutes pre-dose) and 15-minutes post-dose on Day 1
The severity of symptoms of Ajeerna vyadhi will be recorded using VAS scoring. Participants will record a score with a mark at one point along the length of a 100-millimeter (mm) line, where the lowest score 0-mm indicates 'no discomfort' and highest score 100-mm indicates 'worst possible discomfort'. Higher the score, more severe will be the symptoms. Change from baseline will be calculated by subtracting baseline value from the value at 15-minutes.
次要结局
- Change from Baseline in Ajeerna Vyadhi (Acidity, Acid Indigestion, Indigestion, And Associated Nausea) Symptoms Using VAS Scoring After 2-Minutes, 1-Hour, and 2-Hours of Taking ENO Lime(Baseline (0 minutes pre-dose) and 2-minutes, 1-hour, 2-hours post-dose on Day 1)