Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: Defatted Fenugreek Seed Flakes (Fenuflakes): 10 g (scoop size) with breakfast with 300 ml of water intake
Control Intervention1: NIL: NIL
Sponsors
Indus Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female participants between the age of 18 to 60 (both inclusive) years 2 Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial 3 Average score of 3-5 in Gastrointestinal Symptom Rating Scale (GSRS) in at least one subdomain [Constipation, Acidity (reflux), Abdominal pain, Indigestion (bloating), Diarrhea] 4 No new antibiotic usage within 12 weeks prior to consent 5 No new diet interventions within 12 weeks prior to consent 7 Insufficient response to medications affecting gastrointestinal symptoms within the 12-week period preceding consent at the discretion of the investigator.
Exclusion criteria
Exclusion criteria: 1 Score of 6 or 7 in response to any question in Gastrointestinal Symptom Rating Scale (GSRS) 2 Pregnant women, women who are breastfeeding, or women who intend to fall pregnant. 3 History of significant allergies, allergy, or sensitivity to any of the ingredients in supplementation formula. 4 Participants who have participated in any other clinical trial during the past 3 months 5 Any kind of substance abuse (alcohol, tobacco, or any other substance). 6 Participants with clinically significant abnormal laboratory results or uncontrolled disease conditions or who are cognitively impaired and/or who are unable to give informed consent 7 Intake of supplements containing fenugreek 8 Any condition in the investigator s opinion makes the participant unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recording of gastrointestinal symptoms using GSRSTimepoint: At baseline, Week 6, and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy-Food craving or addiction using ScaleTimepoint: At baseline, Week 6, and Week 12;Efficacy-Physical activity using QuestionnaireTimepoint: At baseline, Week 6, and Week 12;Efficacy-Psychological stress using ScaleTimepoint: At baseline, Week 6, and Week 12;Efficacy-Quality of life using questionnaireTimepoint: At baseline, Week 6, and Week 12;Sensory evaluationTimepoint: At Week 12;Safety-Vital parameters, AE/SAETimepoint: At baseline, Week 6, and Week 12;Safety-Laboratory examination, urine and fecal analysisTimepoint: At baseline and Week 12 | — |
Countries
India
Contacts
Public ContactPallavi Deshpande
Poona College of Pharmacy
Outcome results
None listed