Health Condition 1: R198- Other specified symptoms and signsinvolving the digestive system and abdomen
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Age more than 18 years. Chronic history of recurrent GI symptoms i.e. bloating, abdominal discomfort, dyspepsia and constipation of mild to moderate severity GSRS score more than equal to 3 for at least one question for above mentioned Symptoms Participants who are stable, ambulatory and willing to participate
Exclusion criteria
Exclusion criteria: Known cases of defined underlying pathophysiology for GI disorders or known to have GI structural abnormalities Severe cases with gastrointestinal pathology e.g. IBD, colorectal cancer Uncontrolled or severe systemic illnesses Known case of diabetes mellitus History of use of laxatives or GI medications in the past 2 weeks Known allergy to any ingredient of Drakshavaleha Known cases of substance abuse, especially Opioids, including long-term medication Alcoholics or drug abusers Pregnant or lactating woman. Patients who have completed participation in any other clinical trial during the past six months. Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study. Any other condition that the PI considers to be unfavourable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with remission of at least one symptom of FGIDs (assessed through GSRS) after treatmentTimepoint: At the end of 1st, 2nd and 3rd month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Gastrointestinal Symptom Rating Scale (GSRS) scores after interventionTimepoint: Baseline; at the end of 1st, 2nd and 3rd month;2. Change in patient-reported well-being by WHO-5 Wellbeing IndexTimepoint: Time frame: Baseline and at the end of 3rd month;3. Change in VAS score for appetiteTimepoint: felt in the past week;4. Treatment adherence by the participantsTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Kalpana Kachare
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed