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The goal of this clinical trial is to compare the efficacy of four different drugs in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:
Participants will be divided into 3 treatment groups.
The goal of this clinical trial is to compare the efficacy of four different drugs (Rifaximin , Mebeverine, Amitriptyline and Psyllium Husk) in combination for management of irritable bowel syndrome (IBS)-associated diarrhea. The main question to answer is:
• Is there a significant difference in effect of different drug combinations in management of irritable bowel syndrome with diarrhea?
Total of 162 Participants will be enrolled in study.
Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention
Data will be collected using Questionnaire. Questionnaire will be filled by the researcher
SPSS will be used for analysis of data and appropriate test like Chi square Test, Student T test and One way ANOVA will be used to draw conclusions about the efficacy of different drug combinations and their potential side effects between the treatment groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A ( Rifaximin + Mebeverine ) | Active Comparator | Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Mebeverine 135mg twice daily per orally for 2 weeks |
|
| Group B ( Rifaximin + Amitriptyline ) | Active Comparator | Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Tab. Amitriptyline 25mg once daily per orally for 2 weeks |
|
| Group C ( Rifaximin + Psyllium Husk ) | Active Comparator | Tab. Rifaximin 550mg thrice daily per orally for 2 weeks Psyllium Husk 15-30mg once daily per orally for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin 550 MG | Drug | Rifaximin 550 MG Oral Thrice Daily for 2 weeks will be included in all three treatment regimes i.e A, B and C |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Improvement in Frequency of Diarrhea | The study will assess change in number of stools per day from day 0 to day 14 | 2 Weeks |
| Overall Improvement in Characteristic of Diarrhea | The study will assess change in characteristic of stool type from type 6,7 to 4 according to Bristol Stool Chart from day 0 to day 14 | 2 Weeks |
| Overall Improvement in Abdominal Pain | The study will assess change in abdominal pain from day 0 to day 14 | 2 Weeks |
| Compare Efficacy of Treatment Regimes in Treatment Groups | The study will assess and compare the effect of each treatment regime on reduction of diarrhea, improvement in abdominal pain among the treatment groups | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To observe adverse effects of treatment regimes | The study will observe number of participants with adverse effects like Nausea, Stomachache, Dizziness, Tiredness, Joint Pain, Headache, Heartburn, Constipation, Dry Mouth, Sedation and Bloating of drugs in different groups and compare them | 2 Weeks |
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Inclusion Criteria:
Individual of both gender between the age of 18-50 years Diagnosed case of Irritable Bowel Syndrome associated with Diarrhea
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rashid Ali | Bahria University Health Science Campus Karachi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bahria University Health Sciences Campus | Karachi | Sindh | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28367168 | Background | Alaqeel MK, Alowaimer NA, Alonezan AF, Almegbel NY, Alaujan FY. Prevalence of Irritable Bowel Syndrome and its Association with Anxiety among Medical Students at King Saud bin Abdulaziz University for Health Sciences in Riyadh. Pak J Med Sci. 2017 Jan-Feb;33(1):33-36. doi: 10.12669/pjms.331.12572. | |
| 33946961 | Background |
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All collected IPD data will be shared
IPD data will be available 01 year after publication and will be available perpetually
All the data will be assessable to all
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Randomized Control Trial in which participants will be divided into 3 treatment groups i.e. Group A, Group B and Group C.
Stool Frequency, Characteristic of Stool and Abdominal Pain will be assessed at day 0 and day 14 of intervention
At the end of study period , efficacy of different drug combinations and their potential side effects will be compared between the treatment groups
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|
| Mebeverine 135 MG | Drug | Mebeverine 135 MG Oral Twice Daily for 2 weeks will be included in Group A Treatment Regimes |
|
|
| Psyllium Husk | Drug | Psyllium Husk 15-35 MG Oral Once Daily for 2 weeks will be included in Group C Treatment Regimes |
|
|
| Amitriptyline Hydrochloride 25 MG | Drug | Amitriptyline Hydrochloride 25 MG Oral Once Daily for 2 weeks will be included in Group B Treatment Regimes |
|
|
| Altomare A, Di Rosa C, Imperia E, Emerenziani S, Cicala M, Guarino MPL. Diarrhea Predominant-Irritable Bowel Syndrome (IBS-D): Effects of Different Nutritional Patterns on Intestinal Dysbiosis and Symptoms. Nutrients. 2021 Apr 29;13(5):1506. doi: 10.3390/nu13051506. |
| 30400292 | Background | Axelrod CH, Saps M. The Role of Fiber in the Treatment of Functional Gastrointestinal Disorders in Children. Nutrients. 2018 Nov 3;10(11):1650. doi: 10.3390/nu10111650. |
| 33564537 | Background | Bachani P, Kumar L, Kumar N, Fatima M, Naz S, Memon MK, Memon S, Rizwan A. Prevalence of Irritable Bowel Syndrome and Frequency of Symptoms in the General Population of Pakistan. Cureus. 2021 Jan 6;13(1):e12541. doi: 10.7759/cureus.12541. |
| 27862281 | Background | Bai T, Xia J, Jiang Y, Cao H, Zhao Y, Zhang L, Wang H, Song J, Hou X. Comparison of the Rome IV and Rome III criteria for IBS diagnosis: A cross-sectional survey. J Gastroenterol Hepatol. 2017 May;32(5):1018-1025. doi: 10.1111/jgh.13642. |
| 30460770 | Background | Barbara G, Cremon C, Azpiroz F. Probiotics in irritable bowel syndrome: Where are we? Neurogastroenterol Motil. 2018 Dec;30(12):e13513. doi: 10.1111/nmo.13513. |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| C005096 | mebeverine |
| D011620 | Psyllium |
| D000639 | Amitriptyline |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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