None listed
Conditions
Interventions
Intervention1: Herbagut: Unique herbal formulation manufactured by Arjuna Natural Extracts Ltd Kerala India 2 capsules (400 mg each) 1 hour before bedtime with 250ml of water for 4 weeks
Control Inter
Sponsors
Arjuna Natural Extracts Ltd
Eligibility
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| (1) Tolerance to the study product. (2) Adverse events as treatment emergent adverse events (TEAE). Timepoint: (1) After completion of treatment 4 weeks (2) Throughout the study | — |
Primary
| Measure | Time frame |
|---|---|
| (1) Subjects self satisfaction report on improvement of bowel movements compared to placebo. (2) Changes in daily average bowel movement (stool frequency) compared to placebo. (3)Changes in stool consistency (Bristol stool scale) and ease of passage compared to placebo. (4) Subjects feedback on GSRS, WHOQOL and PAC-QOL compared to placebo. (5) Subjects fecal microbiota analysis compared to placebo. Timepoint: (1) 2 and 4 weeks of treatment (2) 2 and 4 weeks of treatment (3) 2 and 4 weeks of treatment (4) 2 and 4 weeks of treatment (5) End of the study | — |
Countries
India
Contacts
Public ContactYogendra Choudhary
Arjuna Natural Extracts Ltd
Outcome results
None listed