Health Condition 1: K590- Constipation
Conditions
Interventions
None listed
Sponsors
Bohan and Co
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged between 25 and 60 years with BMI of 20 to 29 kg/m2. 2. Subjects meet the following Rome-IV diagnostic criteria for Functional constipation: i.Must include two or more of the following: a.Straining during more than ¼ (25%) of defecations b.Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations c.Sensation of incomplete evacuation more than ¼ (25%) of defecations d.Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations e.Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) f.Fewer than three SBM per week g.Loose stools are rarely present without the use of laxatives h. Insufficient criteria for irritable bowel syndrome i.(NOTE: Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis) 3.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Post-menopausal subjects must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 4.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent. 5.Subjects agree to be available for regular follow up throughout the study duration. 6.Subject considered generally healthy as per health history and routine clinical investigations during screening.
Exclusion criteria
Exclusion criteria: 1.Subjects with secondary constipation (caused by medical condition or medication use). 2.Use of drugs or supplements for gastrointestinal motility or laxatives. 3.Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded. 4.Use of dietary supplements like prebiotics or probiotics. 5.Subjects with history of medical conditions like cerebrovascular disease, depression, hypothyroidism, Irritable bowel syndrome or taking medicines like Antacids, Iron supplements, Opioids etc. 6.Women who are pregnant, lactating or planning to become pregnant during the study duration. 7.Subjects with any disease or abnormalities related to gastrointestinal tract, pancreas and liver. 8.Subjects with hypertension and diabetes 9.Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies. 10.Subjects consuming alcohol or smokers. 11.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 12.Expectation of any surgery during the study period. 13.Subject has participated in a clinical study within the last 30 days prior to recruitment or currently participating in another study. 14.Subjects with a known allergy or sensitivity to herbs/spices/plant products in general and/or allergic to botanical ingredients contained in the study product. 15.Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study period in: Patient Assessment of Constipation-Symptoms (PAC-SYM) Timepoint: Day 1,Day 7,Day 30,Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study period in Physician/Patient global assessment (PGA)Timepoint: Day 7,Day 30,Day 60;Change from baseline to end of the study period in Beck anxiety inventory (BAI)Timepoint: Day 1,Day 7,Day 30,Day 60 ;Change from baseline to end of the study period in Beck depression inventory (BDI)Timepoint: Day 1,Day 7,Day 30,Day 60;Change from baseline to end of the study period in Biomarkers (IL-6, IL-10, Gastrin, Cortisol and Serotonin in serum, Zonulin, Diamine Oxidase (DAO))Timepoint: Day 1, Day 60;Change from baseline to end of the study period in Complete spontaneous bowel movement (CSBM)Timepoint: Day 1,Day 7,Day 30,Day 60;Change from baseline to end of the study period in Gastrointestinal Transit time (Dye based Method)Timepoint: Day 1,Day 60;Change from baseline to end of the study period in Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL)Timepoint: Day 1,Day 30,Day 60;Change from baseline to end of the study period in Questionnaire related to GI (GSRS)Timepoint: Day 1,Day 7,Day 30,Day 60;Change from baseline to end of the study period in Questionnaire related to sleep ( LSEQ)Timepoint: Day 1,Day 7,Day 30,Day 60;Change from baseline to end of the study period in Use of rescue medication (Laxative)Timepoint: Day 1,Day 7,Day 30,Day 60;Change from baseline to end of the study period in Victoria Bowel performance scale (BPS)Timepoint: Day 1,Day 7,Day 30,Day 60 | — |
Countries
India
Contacts
Public ContactDr Sowmya
Ayurlife Health Solutions
Outcome results
None listed