None listed
Conditions
Interventions
Intervention1: Gingiver: Oral administration of single dose of Gingever capsules everyday for 56 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo capsules everyday fo
Sponsors
OmniActive Health Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. BMI of 18.5 kg/m2 to 29.9 kg/m2 2. subjects who have less than 3 bowel movements per week for at least 2 weeks 3. Subjects who agree to maintain their usual level of activity throughout the trial period 4. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period. 5. Subjects who agree to stay weight stable during the study period. 6. Female subjects of child bearing potential practicing an acceptable method of birth control 7. Subjects willing to provide written consent. 8. 9. Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion criteria
Exclusion criteria: 1. Having hypersensitivity or history of allergy to the study product. 2.Suffering from a metabolic disorder 3. Subjects diagnosed with functional constipation as per Rome III criteria 4. Major gastrointestinal complication 5. Subjects suffering from lactose intolerance 6. Prior abdominal surgery 7. Current pharmacological treatment related to constipation 8. Laxative/suppository use 9. Daily consumption of probiotics, prebiotics, symbiotic, fibres, fermented milk, and/or yogurt containing probiotics within 1 month prior to screening. 10. Use of any drug or dietary supplement during at least 7 consecutive days known to cause constipation 11. Clinically significant underlying systemic illness that may preclude the participants ability to complete the trial or that may confound the study outcomes 12. Systemic steroid use within 1 month before screening. 13. Eating disorder 14. Having a lifestyle deemed incompatible with the study according to the investigator 15. Self-declare history of alcohol abuse 16. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 17. Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit. 18. Other causes of secondary constipation 19. Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry. 20. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in abdominal, rectal and stool related symptoms and change in fecal microbiota compositionTimepoint: Day 0, Day 3, Day 14, Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in fecal Short Chain Fatty AcidsTimepoint: Day 0, Day 56;Mean change from baseline in gut immunity markersTimepoint: Day 0, Day 56;Mean change from baseline in inflammatory markersTimepoint: Day 0, Day 56;Mean change from baseline in stool consistencyTimepoint: Day 0, Day 3, Day 14, Day 28, Day 56;Mean change from baseline in stool frequency as assessed by number of bowel movementsTimepoint: Day 0, Day 3, Day 14, Day 28, Day 56 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed