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Protocol summary
Phase3, randomized, blinded trial with parallel groups design of 100 patients.
random allocation process is done by permuted block randomization.
A Phase3, randomized, blinded pilot clinical trial with parallel groups design of 32 patients.
random allocation process is done by permuted block randomization.
A Phase3, randomized, blinded pilot clinical trial with parallel groups design of 10032 patients. random allocation process is done by permuted block randomization.
کارآزمایی بالینی آینده نگر دارای گروه کنترل با گروه های موازی، دوسویه کور ،تصادفی شده، فاز3 بر روی 100 بیمار.
تخصیص تصادفی به روش بلوک های تصادفی انجام می پذیرد.
کارآزمایی بالینی آزمایشی آینده نگر دارای گروه کنترل با گروه های موازی، دوسویه کور ،تصادفی شده، فاز3 بر روی 32 بیمار.
تخصیص تصادفی به روش بلوک های تصادفی انجام می پذیرد.
کارآزمایی بالینی آزمایشی آینده نگر دارای گروه کنترل با گروه های موازی، دوسویه کور ،تصادفی شده، فاز3 بر روی 10032 بیمار. تخصیص تصادفی به روش بلوک های تصادفی انجام می پذیرد.
General information
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2021-02-28, 1399/12/10
2021-02-28 00:00:00
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2022-03-19, 1400/12/28
2022-03-19 00:00:00
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2022-05-12, 1401/02/22
2022-05-12 00:00:00
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Our study aimed to investigate the efficacy and safety of loratadine in a clinical trial study with 100 patients.
According to the coronavirus pandemic, our sampling got into trouble, Our hospital was the COVID-19 patient admission center, on the other hand, most patients didn't get serious their IBS-D disease during the COVID-19 pandemic, so referrals to our GI clinic reduced significantly. Finally, the number of participants had the study inclusion criteria reduced to 40 patients in a year and a half,
According to this situation, we request to register our study as a randomized pilot clinical trial Because of our time limitation, if appropriate.
Our study aimed to investigate the efficacy and safety of loratadine in a clinical trial study with 100 patients. According to the coronavirus pandemic, our sampling got into trouble, Our hospital was the COVID-19 patient admission center, on the other hand, most patients didn't get serious their IBS-D disease during the COVID-19 pandemic, so referrals to our GI clinic reduced significantly. Finally, the number of participants had the study inclusion criteria reduced to 40 patients in a year and a half, According to this situation, we request to register our study as a randomized pilot clinical trial Because of our time limitation, if appropriate.
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همانطور که مستحضرید هدف ما انجام یک کارآزمایی بالینی با تعداد 100 بیمار با موضوع ذکر شده بوده است، اما با توجه به شیوع ویروس کرونا و کاهش چشمگیر مراجعات به درمانگاه گوارش، نمونه گیری ما با مشکل مواجه گردید. بیمارستان مدنظر مرکز بستری بیماران کرونا بوده و از آنجا که بیماری IBS بیماری حادی نیست و بیماران مبتلا در شرایط کرونا این بیماری را جدی نمی گرفتند با کاهش شدید مراجعات به درمانگاه گوارشی واقع در این بیمارستان مواجه شدیم. نهایتا در مدت زمان تعیین شده12 ماه (به همراه 6 ماه زمان مجدد جهت افزایش تعداد نمونه ها)، تعداد بیمارانی که شرایط ورود به مطالعه را داشتند به 40 نفر کاهش یافت که ازین تعداد 32 نفر همکاری لازم را داشتند و تا انتهای مطالعه ما را همراهی کردند. ازآنجا که این مطالعه یک پایان نامه دانشجویی بوده و با ادامه دادن آن و صرف زمان بیشتر با مشکل مواجه خواهیم شد و با توجه به شرایط پیش آمده درخواست دارم در صورت صلاحدید، کارآزمایی را به صورت مطالعه Randomized pilot clinical trial ثبت نمایید.
همانطور که مستحضرید هدف ما انجام یک کارآزمایی بالینی با تعداد 100 بیمار با موضوع ذکر شده بوده است، اما با توجه به شیوع ویروس کرونا و کاهش چشمگیر مراجعات به درمانگاه گوارش، نمونه گیری ما با مشکل مواجه گردید. بیمارستان مدنظر مرکز بستری بیماران کرونا بوده و از آنجا که بیماری IBS بیماری حادی نیست و بیماران مبتلا در شرایط کرونا این بیماری را جدی نمی گرفتند با کاهش شدید مراجعات به درمانگاه گوارشی واقع در این بیمارستان مواجه شدیم. نهایتا در مدت زمان تعیین شده12 ماه (به همراه 6 ماه زمان مجدد جهت افزایش تعداد نمونه ها)، تعداد بیمارانی که شرایط ورود به مطالعه را داشتند به 40 نفر کاهش یافت که ازین تعداد 32 نفر همکاری لازم را داشتند و تا انتهای مطالعه ما را همراهی کردند. ازآنجا که این مطالعه یک پایان نامه دانشجویی بوده و با ادامه دادن آن و صرف زمان بیشتر با مشکل مواجه خواهیم شد و با توجه به شرایط پیش آمده درخواست دارم در صورت صلاحدید، کارآزمایی را به صورت مطالعه Randomized pilot clinical trial ثبت نمایید.
This is a randomized controlled trial (RCT),
In this study participants, the main researcher, clinicians ,the data collector , and the Data safety and Monitoring Committee are blinded.
Participants are asked by the blinded clinician to eat the drug . All of the drugs are packaged the same, but some are the Loratadine tablets while others are Placebos.
The blinded data collector collects data from patients every 2weeks.
In the end, the Data collected from both groups are analyzed by data analyst.
This is a randomized controlled trial (RCT),
In this study, participants, the main researcher, clinicians, the data collector, and the Data Safety and Monitoring Committee are blinded.
Participants are asked by the blinded clinician to eat the drug . All of the drugs are packaged the same, but some are the Loratadine tablets while others are Placebos.
The blinded data collector collects data from patients every 2weeks.
In the end, the Data collected from both groups are analyzed by data analysts.
This is a randomized controlled trial (RCT), In this study, participants, the main researcher, clinicians,the data collector, and the Data safetySafety and Monitoring Committee are blinded. Participants are asked by the blinded clinician to eat the drug . All of the drugs are packaged the same, but some are the Loratadine tablets while others are Placebos. The blinded data collector collects data from patients every 2weeks. In the end, the Data collected from both groups are analyzed by data analystanalysts.
Protocol summary
Study aim
Evaluation the clinical efficacy of Loratadine on GI symptoms of IBS-D patients
Design
A Phase3, randomized, blinded pilot clinical trial with parallel groups design of 32 patients.
random allocation process is done by permuted block randomization.
Settings and conduct
The patients with IBS-D referred to the Omid GI Clinic of Ayatollah Rouhani Hospital are randomly divided into a Loratadine group and a control group.
The patients in the Loratadine group receive Loratadine tablets(10mg, oral) once daily and Patients in the control group receive oral Placebo once daily for 4-6 weeks. The patients are followed up once in every 2weeks for 6-8weeks and Gastrointestinal symptoms will be assessed before and after treatment. biographic information, symptoms, response to treatment and adverse drug reactions will be recorded in data collection forms designed for each patient and analyzed. In this study participants, the main researcher, clinicians ,the data collector, and the Data safety and Monitoring Committee are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with IBS-D؛ Age between 18 and 65؛ No abnormalities observed by Sigmoidoscopy؛
Exclusion criteria: Diabetes؛ Renal impairment؛ Cardiovascular disorders؛ Colitis؛ Celiac disease؛ Use of drugs that affect the digestive system
Intervention groups
The patients in the Loratadine group receive Loratadine tablets(10mg, oral) once daily for 4-6 weeks. (if patients do not response to the treatment the dose will be increased to 10mg twice daily).Patients in the control group receive oral Placebo once daily for 4-6 weeks. also all patients receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate).
Our study aimed to investigate the efficacy and safety of loratadine in a clinical trial study with 100 patients.
According to the coronavirus pandemic, our sampling got into trouble, Our hospital was the COVID-19 patient admission center, on the other hand, most patients didn't get serious their IBS-D disease during the COVID-19 pandemic, so referrals to our GI clinic reduced significantly. Finally, the number of participants had the study inclusion criteria reduced to 40 patients in a year and a half,
According to this situation, we request to register our study as a randomized pilot clinical trial Because of our time limitation, if appropriate.
Acronym
IRCT registration information
IRCT registration number:IRCT20201221049782N1
Registration date:2021-04-16, 1400/01/27
Registration timing:registered_while_recruiting
Last update:2022-06-26, 1401/04/05
Update count:1
Registration date
2021-04-16, 1400/01/27
Registrant information
Name
Faezeh Vahidi Motlagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3221 0660
Email address
faezehvhdi1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
2021-02-28, 1399/12/10
Actual recruitment end date
2022-03-19, 1400/12/28
Trial completion date
2022-05-12, 1401/02/22
Scientific title
Clinical efficacy and safety of loratadine in treating irritable bowel syndrome with predominant diarrhea
Public title
Loratadine in treating irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with IBS-D
Age between 18 and 65
No abnormalities on physical examination
Routine CBC
No abnormalities observed by Sigmoidoscopy
Normal thyroid function
Negative routine stool examinations
Exclusion criteria:
Diabetes
Renal impairment
Cardiovascular disorders
Psychiatric disorders
Colitis
Celiac disease
Use of drugs that affect the digestive system
Use of Analgesics
Use of Antihistamines
Loratadine intolerance
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with IBS-D are randomly divided into a Loratadine group and a control group. random allocation process is done by permuted block randomization.
25 Blocks (with 4 subjects per block and AABB permutations) is made by Randomization.com Website and placed on the same drug packages by coding.
Letters A and B, the intended permutation and other required information are entered in randomization website.
100 phrases with letters A or B are achieved, which randomly indicate Who should take loratadine and who should take placebo from the first to the hundredth patient,(A=loratadine ,B=placebo).
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a randomized controlled trial (RCT),
In this study, participants, the main researcher, clinicians, the data collector, and the Data Safety and Monitoring Committee are blinded.
Participants are asked by the blinded clinician to eat the drug . All of the drugs are packaged the same, but some are the Loratadine tablets while others are Placebos.
The blinded data collector collects data from patients every 2weeks.
In the end, the Data collected from both groups are analyzed by data analysts.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of babol university of medical sciences
Street address
Babol university of medical sciences, Ganjafrooz street, babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۱۳۶۷
Approval date
2021-01-30, 1399/11/11
Ethics committee reference number
IR.MUBABOL.REC.1399.463
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome with diarrhea
ICD-10 code
K58.0
ICD-10 code description
Irritable bowel syndrome with diarrhea
Primary outcomes
1
Description
Diarrhea Frequency
Timepoint
before treatment and 14, 28, 42 and 56 days after beginning of treatment
Method of measurement
questionnaire
2
Description
Severity of pain
Timepoint
before treatment and 14, 28, 42 and 56 days after beginning of treatment
Method of measurement
questionnaire
3
Description
Abdominal pain frequency
Timepoint
before treatment and 14, 28, 42 and 56 days after beginning of treatment
Method of measurement
questionnaire
4
Description
defecation urgency
Timepoint
before treatment and 14, 28, 42 and 56 days after beginning of treatment
Method of measurement
questionnaire
5
Description
bloating
Timepoint
before treatment and 14, 28, 42 and 56 days after beginning of treatment
Method of measurement
questionnaire
Secondary outcomes
1
Description
Quality of life score
Timepoint
before treatment and 14, 28, 42 and 56 days after beginning of treatment
Method of measurement
Irritable bowel syndrome-Quality of life questionnaire(IBS-QOL)
Intervention groups
1
Description
Intervention group: The patients in the Loratadine group receive Loratadine tablets(10mg, oral) made by Pharmachemie pharmaceutical company once daily for 4-6 weeks (if patients do not response to the treatment the dose will be increased to 10mg twice daily), also they receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate).
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group receive oral Placebo made by Pharmachemie pharmaceutical company once daily for 4-6 weeks. also they receive routine therapeutic regimen of IBS-D (Amitriptyline 10mg, Loperamide and diphenoxylate).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Specialty and subspecialty clinic of Ayatollah rouhani hospital
Full name of responsible person
Hasan Abedi Valoukolaie
Street address
Omid Specialty and subspecialty clinic, Ayatollah rouhani hospital,Ganjafrouz street
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3220 0487
Email
rohani@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmachemie pharmaceutical factory
Full name of responsible person
Motahare rouhi
Street address
No. 2, West forth Ave., sixteenth Street, before Azadegan, 8kilometers of Karaj_Tehran road, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1389794581
Phone
+98 21 4452 5190
Email
info@pharmachemie.co
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pharmachemie pharmaceutical factory
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatere seyedalipour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Medicinal Care unit, first floor, Babol university of medical science, Ganjafrooz street, babol
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Email
f_seyedalipour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatere seyedalipour
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Medicinal Care unit, first floor, Babol university of medical science, Ganjafrooz street, babol