Health Condition 1: K580- Irritable bowel syndrome with diarrhea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Based on Rome IV criteria for IBS-D. . Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: 1. Related to defecation (Pain). 2. Associated with a change in frequency of stool. 3. Associated with a change in form (appearance) of stool.
Exclusion criteria
Exclusion criteria: 1. Patients below 18 and above 60 years. 2. Known cases of Malignancy, Inflammatory bowel disease (Ulcerative colitis, Crohns disease) and, acute conditions like cholera, gastro-enteritis. Intestinal obstructions, etc. 3. Patients with disease requiring long term treatment e.g., Tuberculosis, Hypertension, Diabetes Mellitus, Malignancy, Liver or Kidney dysfunction, Hypothyroidism, Hyperthyroidism. 4.Patients suffering from Amoebic dysentery. 5.Diagnosed cases of coeliac disease, bowel resection, other gastrointestinal disorder contributing to the diarrhea, unexplained weight loss or rectal bleeding. 6.Use of probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids. 7. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the signs and symptoms of Ishal e Muzmin (Irritable Bowel Syndrome-Diarrhea (IBS-D)). Which will be assessed on the basis of IBS Severity Scoring Scale (IBS-SSS) and Gastrointestinal Symptom Rating Scale (GSRS-IBS).Timepoint: At baseline and every two weeks during the protocol treatment. (i.e., at 0, 2nd, 4th, and 6th week). | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological and biochemical investigations for safety assessment i.e.,Haemogram, LFT, KFT, stool and Urine R/M.Timepoint: At baseline, 2nd week and at the end of protocol treatment.( i.e., 0, 2nd and 6th week) | — |
Countries
India
Contacts
Central Council for Research in Unani Medicine (CCRUM)