Efficacy and safety of GutGard in the management of gastro-esophageal reflux (GER)-related symptoms - A Phase III, single centre, double-blind, parallel group, randomized placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Among patients with Gastro-esophageal Reflux (GER) related symptoms predominantly heartburn, to assess the efficacy of GutGard 150mg (75mg twice daily) in comparison to those receiving placebo over a 4-week period using
研究概览
简要总结
Gutgard® is a combination of natural flavonoids for gut health developed by Natural Remedies Pvt. Ltd. Gutgard® is derived from the roots of Glycyrrhiza glabra L. commonly known as licorice or Mulethi, widely used in Ayurveda from ancient period for reducing heartburn, to pacify altered pitta and to heal ulcers. Gutgard® is a standardized herbal composition containing more than 40 flavonoids as identified by LCMS and is free from glycyrrhizin. Flavonoids are a class of secondary metabolites of plants with multiple health benefits. The pharmacological actions of flavonoids viz.,antioxidant, anti-inflammatory, immunomodulatory and antimicrobial properties can be considered beneficial for gut health. Clinical, preclinical and in-vitro studies have demonstrated the benefit as well as the safety of Gutgard® in gut health. Preclinical studies demonstrated prokinetic effects and effects against constipation and anti-ulcer effects. While invitro studies demonstrated anti-inflammatory activity of Gutgard. In addition, Gutgard is clinically tested to
manage the symptoms of FD (functional dyspepsia) and to reduce the gastric load of Helicobacter pylori. Gutgard® supports normal and healthy gastrointestinal tract. With respect to safety Gutgard is devoid of glycyrrhizin that is known to cause hypertension. Gutgard is tested in acute toxicity study demonstrated that it is safe upto 5g/kg rat body weight. In subchronic toxicity study conducted as per OECD guidelines for toxicity Gutgard demonstrated NOAEL of 1000 mg/kg rat body weight. The clinical studies on gutgard did not demonstrate any major treatment related adverse effects and is found to be well tolerated by humans.
Pharmacological actions of Gutgard® Factors that are considered to be involved in FD and IBS (Irritable bowel syndrome) can be grouped under three broad physiological functions as below.
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Normal bowel movement or gut motility
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Immunity or gastroprotective function
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Anti-microbial activity against H. pylori
Currently, we propose a phase III clinical trial among participants who have GER related symptoms (Heartburn and reflux) to see if it improves the symptoms. we also objectively measure the change in LES pH and pressure. We also look at the rate of gastric emptying
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Apparently healthy adults of any gender
- •60 years of age, willing to provide consent affected by symptoms of GER
- •History of GER-related symptoms for at least 1 month prior to study inclusion and otherwise healthy
- •Not participated in any other interventional trials in the last 1 month before trial recruitment
- •Willing to discontinue medications like H2 Receptor antagonists, Antacids, Prokinetics and supplements that have been prescribed for the GER related symptoms and not on any of these agents in the last 10 days before randomization
- •Presence of symptoms of at least 2 days in the week preceding randomization.
排除标准
- •Presence of any of the following red flag symptoms of dyspepsia – Iron deficiency anaemia, dysphagia, weight loss, persistent vomiting, GI bleed, epigastric mass
- •Women of reproductive age who are pregnant / lactating / not willing for adequate contraception
- •History of allergy to any medications including alternate system of medications
- •History of uncontrolled diabetes (Random Blood Sugar > 200mg%)
- •Inability to follow-the protocol or expressed inability to complete all follow-ups
- •Abnormalities in the liver function tests (defined as total bilirubin >1mg% or SGOT / SGPT > 3 times the upper limit of normal)
- •Abnormal renal function test (Creatinine > 1.4mg%)
- •Congestive cardiac failure and other medical conditions which the investigator feels will affect the pharmacokinetic parameters of the study drug
- •History of erosive esophagitis, Barrett’s esophagus, tumoral pathologies, atypical pathology without heartburn and ulcer
- •Severe disease that affect activities of daily living as assessed by GERD – HRQoL scale, where the score for heartburn and regurgitation > 3
- •Presence of HIV, HbsAG or HCV positive and any other medical/ surgical condition the investigator feels may cause harm to the participant.
结局指标
主要结局
Among patients with Gastro-esophageal Reflux (GER) related symptoms predominantly heartburn, to assess the efficacy of GutGard 150mg (75mg twice daily) in comparison to those receiving placebo over a 4-week period using
时间窗: Days 7, 14, 28 & 35
1. GERD Health-Related Quality of Life (GERD-HRQoL) on D28 .
时间窗: Days 7, 14, 28 & 35
2. Symptoms severity score as assessed by Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) on days 7, 14, 28 and 35
时间窗: Days 7, 14, 28 & 35
次要结局
- Frequency & level of severity of individual GER related symptoms as assessed by GSAS(Days 7, 14, 28, 35)
- Number of rescue medications used(Day 14, 28 & 35)
- Change in Quality of life score (Global Assessment Questionnaire)(Day 28)
- Proportion of participants with rebound effects (requirement of at least 1 day of rescue medication or ≥ 2 days of mild symptoms)(Day 35)
- Medication Adherence(Days 28)
- Change in pH at lower oesophagus and lower esophageal sphincter pressure in 10% of participants(Anytime between days 26-28)
- Mean percent change in gastric emptying as measured by solid meal scintigraphy(Day 28)
- Mean Percent Change in gastric emptying as assessed by liquid meal scintigraphy in those with abnormal solid meal scintigraphy(Day 28)
- Proportion of ADRs(Days 7, 14, 21 & 28)