A Randomized, Double Blind, Placebo Controlled, Parallel Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Functional Dyspepsia.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall Treatment efficacy (OTE)
研究概览
简要总结
Functional dyspepsia is a clinical syndrome that is characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of underlying organic disease that can explain the symptoms. Pharmacological therapy for patients with functional dyspepsia remains unsatisfactory. In addition to poor efficacy, pharmacological agents are associated with a risk of adverse effects. Herbal medicine might be an attractive alternative based on the perception of its natural approach and low risk of adverse effects.
Thus OLNP-06 as a ginger extract powder with standardises to high percentage of Gingerol may fulfil the unmet needs of Indian subjects suffering from FD. Hence this study is being conducted to evaluate efficacy and tolerability of OLNP-06 compared to placebo for the treatment of functional dyspepsia in Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
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 subjects age
- •55 years.
- •Diagnosis of functional dyspepsia, Postprandial distress Syndrome by fulfilling Rome-III criteria
- •Subjects with at least one of the following two for at least 6 months i)Post prandial fullness ii)Early satiety or Subjects with two or more of the following symptoms at a moderate or severe level within the previous 03 months (At least one symptoms of postprandial fullness, upper abdominal bloating or early satiety should be included) i)Upper abdominal pain ii)Upper abdominal discomfort iii)Post Prandial fullness iv)Upper abdominal bloating v)Early satiety vi)Nausea vii)Vomiting
- •Female Subjects of childbearing potential, willing to use effective contraception during the study and willing to undergo pregnancy test.
- •Written informed consent signed by patient and willing to comply with the study procedure.
排除标准
- •Pregnant and lactating female patients.
- •Subject having heartburn as the most bothersome symptom or if they had moderate or severe heartburn during the baseline period.
- •History of peptic ulcer or gastro esophageal reflux disease (GERD).
- •Current prominent symptoms of irritable bowel syndrome.
- •Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy.
- •Use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, H2 receptor blockers, bismuth, or proton pump inhibitors and prokinetics in the preceding two weeks.
- •Participation of other clinical trials within the last 1 month.
- •Evidence or history of clinically significant (in the judgment of the Investigator) haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
- •Patients with alcohol abuse (daily alcohol intake more than 40g), drug dependence or neuropsychiatric disorders that are difficult to control, as well as others who are not appropriate to participate in a drug trial;
- •Patient with known history of hypersensitivity to any ingredient of investigational product.
- •Any medical condition deemed exclusionary by the Principal Investigator.
- •Subject has a history of drug and / or alcohol abuse at the time of enrolment.
结局指标
主要结局
Overall Treatment efficacy (OTE)
时间窗: Day 14 and Day 28
次要结局
- Elimination rate for each individual Symptom(Screening, Day 14 and Day 28)
- Elimination rate (score 0) of all three major symptoms