A randomized, double blind, placebo controlled, single centre study to evaluate the effect of a herbal formulation on gastrointestinal health and symptoms.

Arjuna Natural Extracts Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•(1) Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
•(2) BMI: 20 - 30 kg/m2.
•(3) Healthy adult men or women with self described unsatisfactory bowel habit.
•(4) Average Bristol stool type 1 â??2.
•(5) Gastrointestinal symptom rating scale with every question under 3 points.
•(6) No regular use of fibre supplementation over the month prior to the screening visit, and no more than 2 standard doses in the past 1 month prior to the screening visit.
•(7) Also, willing to discontinue fibre supplementation and other probiotics, prebiotics, fermented milk, yoghurt or laxatives at least 4 weeks prior to and during the study phase.
•(8) The subject must be able to comply with study procedures in the opinion of the investigator.
•(9) Female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period.
•(10) Ability to understand the patient information sheet and instructions in english, hindi, and local language and able to provide informed consent.

•(1) Subjects with or prior history or presence of clinically significant gastrointestinal disease.
•(2) Allergy or intolerance to lactose or any other food ingredient.
•(3) Regular consumption of probiotics, fibre supplements, prebiotics, yogurt, laxatives.
•(4) Any clinical relevant abnormalities in the screening visit medical examination or alarm features or any other serious illness.
•(5) Prior abdominal surgery (including gastric bypass or laparoscopic banding)
•(6)Ongoing therapy with any drugs known to affect gut motility, such as prokinetic agents, anti-emetic agents, anxiolytics, antidepressive agents, narcotic analgesic agents, anticholinergic agents for ibs, medications for constipation, 5HT3 antagonists, anti-diarrheal agents, opiate agents used to treat diarrhoea, nsaids, other antibiotics taken during or within 4 weeks of study onset, magnesium-containing antacids
•(7) Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions.
•(8) Participation in another study with any investigational product within 3 months of screening
•(9) Drug and/or alcohol abuse;
•(10) Unwillingness to consent to the study.

发起方

Arjuna Natural Extracts Ltd