Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: Vestige Aloe Vera Capsule: Frequency: - One Capsule to be taken 2 times a day orally before meals.
total duration: - 56 days
Route of administration: - Oral
Control Intervention1: stan
Sponsors
Vestige Marketing Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subject is willing and able to give written informed consent. Male and Female subjects aged 18 and 65 years IBS according to the Rome III criteria The Rome III criteria is based on pain symptoms and considers pain to be the primary symptom of IBS. The Rome III criteria require recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months, which is associated with two or more of the following: • Improvement with defecation • Onset associated with a change in stool frequency • Onset associated with a change in stool form (appearance) Patients who are taking any medication should continue the same dosage during the study. Subject is willing, able, and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1. Any gross Gastrointestinal pathology 2. Suffering from any chronic neuroendocrine or metabolic disorders. 3. Patients who are too sick for consultation 4. Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life 5. Major gastro-intestinal surgery in last 6 month 6. Pregnant and lactating women 7. Any other condition that in the investigator’s judgment might interfere with study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bowel function-stool frequency and consistencyTimepoint: Day 0 to Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Abdominal symptoms (questionnaire based) The Quality-of-Life Scale (QOLS) Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study. [ Time Frame: Day 0 to Day 56] Timepoint: Day 0 to Day 56 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd
Outcome results
None listed