Health Condition 1: K590- Constipation
Conditions
Interventions
None listed
Sponsors
Target Institute of Medical Education and Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects presenting with two or more of the following for the last 3 months with symptom onset at least 6 months prior to diagnosis: a). Straining during more than one fourth (25 percent) of defecations b). Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than one fourth (25 percent) of defecations c). Sensation of incomplete evacuation more than one fourth (25 percent) of defecations d). Sensation of anorectal obstruction/blockage more than one fourth (25 percent) of defecations e). Manual maneuvers to facilitate more than one fourth (25 percent) 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 laxative h). Insufficient criteria for irritable bowel syndrome 2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study. (The Rome IV diagnostic criteria for Functional constipation, 2016)
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with colonic inertia. 2. Subjects who have recently undergone abdominal surgery 3. Subjects with history of anorectal surgery. 4.Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders etc.) 5. Subjects diagnosed with structural abnormalities, like: i. Anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome ii. Perineal descent iii. Colonic and rectal mass or tumor with obstruction e.g., adenocarcinoma iv. Colonic stricture: radiation, ischemia, diverticulosis v. Intestinal obstruction 6. Subjects with uncontrolled DM and hypertension and Tuberculosis. 7. Known cases of HIV, tuberculosis, hypo and hyperthyroidism 8. Known cases of renal or liver dysfunction. 9. Subjects diagnosed with neurological problems like, i. Parkinson s disease ii. Multiple sclerosis iii. Sacral nerve damage (prior pelvic surgery, tumor) iv. Paraplegia v. Autonomic neuropathy 10. Subjects on chronic medication (greater than 60 days) and or who are on medications known to cause constipation. 11. Pregnant or lactating females 12. Subjects allergic or atopic to any of the ingredients of the study medications 13. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in frequency of bowel movementsTimepoint: screening visit, baseline visit, day 7, day 14 and day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in stool form using graded scale 2. Changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual maneuvers required & average time spent for bowel evacuation 3. Changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension, bloating, acidity on graded scale 4. Global assessment of overall change as per the investigator and subject 5. Assessment of tolerability of study product as per the investigator and subject by assessing Adverse Events, Adverse Reactions 6. Assessment of laboratory investigations such as Blood sugar fasting, Liver profile (SGOT, SGPT, Sr. Bilirubin) and Renal Profile (Sr. Creatinine) Timepoint: screening visit, baseline visit, day 7, day 14 and day 21 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt Ltd
Outcome results
None listed