Health Condition 1: K590- Constipation
Conditions
Interventions
None listed
Sponsors
Patanjali Research Institute governed by Patanjali Research Foundation Trust, Haridwar Uttarakhand
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged greater than or equal to 18 years. 2. Subjects fulfilling greater than or equal to two on Rome IV diagnostic criteria for Functional Constipation 3. Non-pregnant and non-lactating female subjects. 4. Signed informed consent for study-specific procedures. 5. Availability and willingness to complete all study visits and procedures per protocol.
Exclusion criteria
Exclusion criteria: 1. Patients who were on medications known to cause constipation (like opioid analgesics, antidepressants, i.e., amitriptyline and imipramine, anticonvulsants, and aluminium-containing antacids). 2. Patients with a history of abdominal or anorectal surgery in the past one year and those with renal or liver dysfunction or colonic inertia or structural abnormalities of the gastrointestinal tract or uncontrolled systemic ailments (like Human immunodeficiency virus and Tuberculosis) or neurological problems (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy). 3. Functional gastrointestinal disorders other than Functional constipation (i.e., IBS, GERD etc.) 4. Pregnancy or breastfeeding. 5. Known hypersensitivity to any excipients of the intervention. 6. Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator’s opinion. 7. Any other medical condition that, in the opinion of the investigator, makes the patient incompetent to participate in the trial or places the patient at potential risk, e.g. any chronic comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in mean weekly stool frequency and stool form through Bristol Stool Form Scale.Timepoint: Day 15, 30 and 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in abdominal symptoms such as bloating, pain, discomfort, straining, incomplete bowel movement, and sense of incomplete evacuation through patient assessment of constipation symptom questionnaire. Improvement in patient assessment Quality of Life through Patient Assessment of Constipation Quality of life Patient-reported treatment satisfaction through Patient Global Impression of Change (PGI-C). Association between physical activity and Constipation abdominal symptoms.Timepoint: Day 15, 30 and 45 | — |
Countries
India
Contacts
Public ContactDr Anurag Sharma
Patanjali Yog Gram
Outcome results
None listed