Health Condition 1: K590- Constipation
Conditions
Interventions
None listed
Sponsors
Sri Karumalaiyaan Mooligai
Eligibility
Inclusion criteria
Inclusion criteria: Male/Female participants =18 years of age at the time of consent 1. Participants with loose stool being rarely present without the use of laxatives 2. Participants with insufficient criteria for irritable bowel syndrome 3. Participants presenting with two or more of the following for the last three months with symptom onset at least six months prior to diagnosis: (a) Straining during at least 25% of defecations (b) Lumpy or hard stools at least 25% of defecations (c) Sensation of incomplete evacuation at least 25% of defecations (d) Sensation of anorectal obstruction/blockage at least 25% of defecations (e) Manual maneuvers to facilitate at least 25% of defecations, eg: digital evacuation, support of the pelvic floor (f) Fewer than three defecations per week and those in whom loose stools were rarely present without the use of laxatives] 4. Female participant of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post-menopausal (demonstration of total cessation of menses for = 1 year from the date of the screening visit) 5. Female participants of childbearing potential who agree to use two forms of contraception, one of which must be a barrier method, during the full duration of the study 6. Participants with a stool form score ranging from 1 to 3 on the “Bristol Stool Form Scale" 7. Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1 Participants with obstructive disorders and neurologic problems 2 Participants taking concomitant medications which are known to cause constipation like opioid analgesics, antidepressants, i.e., amitriptyline and imipramine, anticonvulsants, and aluminum-containing antacids) 3 Participants on chronic laxative medication(Greater than 60 days) 4 Participants with IBS, Belching disorders, etc. participants 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 gastro-intestinal tract or uncontrolled systemic ailments (like Human immunodeficiency virus, Diabetes mellitus, and Tuberculosis) or neurological problems (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy) 5 Participants who are allergic to any of the ingredients of the investigational product 6 Pregnant and female lactating women at the time of screening 7 Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in frequency of bowel movements and changes in stool form assessed using the “Bristol stool form scale.Timepoint: Day 1,Day 7,Day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. a. Changes in the following symptoms: - straining on defecation - sensation of incomplete evacuation - sensation of anorectal blockage - manual maneuvers required - average time spent for bowel evacuation b. Overall/global improvement (by subject and investigator) on 4-point scale. 2. Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE).Timepoint: Day 1,Day 7,Day 15. | — |
Countries
India
Contacts
Public ContactBrindha Arumugam
iDD Research Solutions Pvt Ltd
Outcome results
None listed