Health Condition 1: null- Functional Constipation
Conditions
Interventions
Intervention1: Ayulax Capsule: Each Capsule Contains Sanai Patra (Cassia angustifolia), Trivruta (Operculina turpethum) , Haritaki (Terminalia chebula), Yavani (Trachyspermum ammi), Shatapushpa (Pimpi
Sponsors
Welex Laboratories 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 at least 25 percent of defecations b. Lumpy or hard stools at least 25 percent of defecations c. Sensation of incomplete evacuation at least 25 percent of defecations d. Sensation of anorectal blockage at least 25 percent of defecations e. Manual maneuvers to facilitate at least 25 percent of defecations f. Fewer than three defecations per week 2. Subjects having stool form between 1 to 3 on the Bristol Stool Form Scale
Exclusion criteria
Exclusion criteria: 1. Subjects with diagnosed 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 with serious uncontrolled & diagnosed systemic ailments like HIV, DM and Tuberculosis. 6. Subjects with renal or liver dysfunction 7. Pregnant or lactating females 8. Subjects with disturbed thyroid functions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of Ayulax Capsule in the Management of Functional Constipation by assessing changes in frequency of bowel movementsTimepoint: 14 days and 21 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in stool form 2. Changes in symptoms of functional constipation 3. Changes in associated clinical symptoms 4. Global assessment for overall improvement by the physician 5. Global assessment for overall improvement by the Patient 6. Tolerability of drug by the physician and by patient 7. Adverse events 8. Laboratory parameters Timepoint: 14 days and 21 days | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed