Health Condition 1: K590- Constipation
Conditions
Interventions
None listed
Sponsors
Lupin Life Consumer Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: For Both Cohorts: 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 forth (25 percent) of defecations b. Lumpy or hard stools (Bristol Stool Form Scale 1 to 2) more than one forth (25 percent) of defecations c. Sensation of incomplete evacuation more than one forth (25 percent) of defecations d. Sensation of anorectal obstruction/blockage more than one forth (25 percent) of defecations e. Manual manoeuvres to facilitate more than one forth (25 percent) of defecations (e.g., digital evacuation, support of the pelvic floor) f. Fewer than three significant bowel movements (SBM) per week g. Loose stools are rarely present without the use of laxatives 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. 3. BMI greater than or equal to 23 Kg per square meter For Cohort 1 (PMS Cohort): 1. Female subjects between the age of 18 to 40 years (both inclusive) 2. Subject with menstrual cycle range not longer than 31 or shorter than 24 days 3. Subject with at least one premenstrual symptom. For Cohort 2 (Menopause Cohort): 1. Female subjects between the age of 40 to 55 years (both inclusive) 2. Having irregular menstrual cycles (greater than or equal to 3 months) indicating perimenopausal status or with cessation of menstrual period for at least three months within the previous 12 months 3. Participants with at least one symptom of menopause like anxiety. Palpitation, night sweats, hot flushes etc. 4. Participants who have not used HRT or any other medicine for at least 3 months prior to entry into the study.
Exclusion criteria
Exclusion criteria: FOR BOTH THE COHORTS 1. Subjects diagnosed with colonic inertia. 2. Subjects who have recently undergone abdominal surgery 3. Subjects with history of anorectal surgery over the last 12 months 4.Subjects diagnosed with IBS 5. Subjects diagnosed with structural abnormalities, like: a. Anorectal: rectal prolapse, rectocele, rectal intussusceptions, anorectal stricture, solitary rectal ulcer syndrome b. Perineal descent c. Colonic or rectal mass or tumor with obstruction e.g., adenocarcinoma d. Colonic stricture: radiation, ischemia, diverticulosis e. Intestinal obstruction 6. Subjects with uncontrolled DM and hypertension 7. Known cases of HIV, tuberculosis, hypo and hyperthyroidism 8. Known cases of renal or liver dysfunction 9. Subjects diagnosed with neurological problems like, a. Parkinson s disease b. Multiple sclerosis c. Sacral nerve damage (prior pelvic surgery, tumor) d. Paraplegia e. 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 |
|---|---|
| For Both Cohorts: Change in frequency of bowel movements For Both Cohorts: Change in body weight, BMI and anthropometric measurements Timepoint: Screening visit, Baseline visit, Day 30, Day 60, Day 90, and Day 105 | — |
Secondary
| Measure | Time frame |
|---|---|
| For Both Cohorts: Assessment of defecation latency following administration of study medicine using subject diary For PMS Cohort: 1. Assessment of pain in abdomen or cramps using VAS 2. Assessment of premenstrual symptoms (PMS) For Peri Menopause and Menopause Cohort: Assessment of menopausal symptoms For Both Cohorts: Assessment of quality of life For PMS Cohorts: Assessment of use of rescue medications For Both Cohorts: 1. Assessment of stool form on graded scale 2. Assessment of symptoms of irregular bowel habits 3. Assessment of associated clinical symptoms 4. Global assessment of overall change 5. Assessment of tolerability of study products 6. Adverse Events or Adverse Drug Reactions 7. Assessment of laboratory investigations Timepoint: Screening visit, Baseline visit, Day 30, Day 60, Day 90, and Day 105 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed