An open-label clinical study to evaluate the efficacy and safety of Dizester® Herbal in Patients suffering from functional dyspepsia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in symptoms on Reflux Disease Questionnaire
研究概览
简要总结
Introduction andbackground
Functional dyspepsiais defined as “the presence of epigastric burning, continual epigastric pain,postprandial fullness or early satiety in the absence of apparent organicdiseaseâ€Â affecting significant population worldwide. Gastric acid hypersecretion is one of the probable causes of dyspepsia. Dizester® herbal is a poly herbal,formulation containing various clinically proven plant ingredients possessingantispasmodic, carminative and appetite stimulant properties. Its componentsare traditionally used for the management of hyper acidity, dyspepsia and variousGI disorders. It also works as diuretic, anti-inflammatory, and protectiveagainst gastric mucosal lesion. However, its efficacy and safety were notevaluated in a randomised trial. Hence, the present study is planned toevaluate the efficacy and safety of Dizester® in patients suffering from functional dyspepsia.
StudyObjectives
i. To evaluate efficacy ofDizester® herbal formulation in patients suffering from functionaldyspepsia.
ii. To evaluate safety of theinvestigational product.
Endpoints
- Improvement in symptoms on Reflux Disease Questionnaire
- Improvement in The Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)
- ImprovementGERD-Health Related Quality of Life Questionnaire
- Improvement in visual analogue scale (VAS) for pain
- Improvement in Investigators Assessment Symptomatic
- Changes in liver and renal function
- Changes in hemogram (Hb, TLC, DLC)
Descriptionof study design
Thiswill be an open labelled, randomized placebo controlled study in patients sufferingfrom functional dyspepsia. Thestudy will be carried out at All India Institute of Medical Sciences,Bhubaneshwar, Odisha. The patients will be screened for eligibility and eligible subjects will be evaluated on days 0,7 and 14. for 4 weeks a with anexpected study duration of 6-8 months.
After baseline assessment, the eligible participants who give written consent will be enrolled for the study. Theenrolled patients will receive Dizester® Herbal as per dosing schedule. Patientdata will be recorded in individual Case Record Form (CRF) at baselines, aftertwo weeks and four weeks. Counselling sessions for informed consent processwill be done face to face. Laboratory investigations will be doneat baseline as well as at the end of the treatment.
STATISTICSSamplesize - The study will be conducted on 80 subjects suffering from functional dyspepsiaStatisticalmethods - Data will be entered into the Microsoft Excel andanalyzed in the Statistical Package for the Social Sciences software (version19.0, IBM SPSS). Primary endpoint, SF-LDQ, GERD-HRQOL, VAS will be analysedusing t-test. Improvement in Investigators Assessment Symptomatic and adversedrug events will be analysed using chi-square test. p value < 0.05 will beconsidered statistically significant.
Analysis Sets - Two populations will be considered for theanalysis: The intention-to-treat (ITT) population, per protocol (PP).
- Intention-to-treat (ITT) Population - ITT population for treatment effects including all subjects having received IP at least once and having at least one measurement of one of the treatment effect parameters during the treatment period.
- Per-protocol (PP) population - PP population will include those subjects of the full analysis set without major protocol deviation to protocol violations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients in the age group between 18 to 65 years of either sex.
- •2.Patients able to provide informed consent.
- •3.Subject fulfilling the Rome IV criteria for functional dyspepsia which includes one or more of the following •Bothersome postprandial fullness •Bothersome early satiation •Bothersome epigastric pain •Bothersome epigastric burning and •No evidence of structural diseases (including the upper endoscopy) that is likely to explain the symptoms •Must fulfill criteria for Postprandial Distress Syndrome and or Epigastric Pain Syndrome.
- •â€¢Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
- •4.Patients will included on the basis of signs and symptoms of Non ulcer dyspepsia, epigastric pain, burning sensation over epigastrium/ retrosternal region, sour, bitter eructation, nausea, vomiting, indigestion and abdominal distension.
排除标准
- •1.Patients on Proton pump inhibitors 2.Pregnant or lactating women or with infants less than 1 year 3.Any preexisting condition or contraindications like CAD, abnormal creatinine levels, liver dysfunction.
- •4.Patients with alarm features like unintentional weight loss, recurrent vomiting, dysphagia, hemetemesis, melena, fever, jaundice, or anemia 5.Any kind of organic lesion such as peptic ulcer, tumor of any kind, stricture, or structural deformity.
- •6.A previous endoscopic diagnosis of erosive gastroesophagitis or Barretts esophagus 7.Subject with known history of gastric bleeding, intestinal obstruction or perforation, and previous gastrointestinal surgery.
结局指标
主要结局
Improvement in symptoms on Reflux Disease Questionnaire
时间窗: Days 0 and 7 and 14
Primary End point
时间窗: Days 0 and 7 and 14
次要结局
- •Improvement in The Short Form Leeds Dyspepsia Questionnaire(•Improvement GERD Health Related Quality of Life Questionnaire)