A randomized controlled open label clinical study to evaluate the safety and efficacy of Active Antacid Suspension (DRF/AY/5018) and Active Antacid Tablets(DRF/AY/4026) in comparison with standard modern treatment in management of hyperacidity and functional dyspepsia

Dabur India Limited0 个研究点目标入组 127 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or Female subjects in the age group of 20 years to 50 years.
•2. Subjects with greater than or equal to 24% of dyspepsia as per the Hong Kong Index of Dyspepsia
•3. Subjects with absence of any clinical or ultrasonographic evidence of organic disease that was accounted for the symptoms
•4. Subjects who were willing to sign informed consent and to come for regular followup
•examinations as & when required.
•5. In the event of subject undergoing treatment for dyspepsia, washout period of 2 days was given prior to inclusion.

•1.Subjects with presence of or history of peptic and duodenal ulcers disease or gastric malignancy any gastrointestinal surgery, reflux oesophagitis, any upper or lower G.l. bleeding, with clinical evidence of irritable bowel syndrome or any psychiatric disease.
•2. Subjects with clinically diagnosed serious medical or surgical illness (like: Diabetes,
•CAD, HT, SLE, Rheumatoid Arthritis, Psoriatic Arthritis) where compliance was difficult.
•3. Subjects not willing to follow up for the study visits.
•4. Subjects with age range below 20 years and above 50 years
•5. Uncooperative Subjects or subjects not willing to sign Informed Consent or giving
•consent for study required procedure like endoscopy.

发起方