Efficacy of traditional Persian remedy of Melissa officinalis, Rosa damascena and Pimpinella anisum on clinical symptoms of patients with irritable bowel syndrome constipation-predominant (IBS-C).
Determining the efficacy of Persian medicine remedy of Melissa officinalis, Rosa damascene, and Pimpinella anisum on constipation-predominant Irritable Bowel Syndrome Severity Score and quality of life compared with placebo.
Design
Phase 3 controlled clinical trial with a parallel design, double-blind, blocked randomization, with a sample size of 60 was designed.
Settings and conduct
This study would be performed at the Kerman clinic of gastrointestinal diseases in Afzalipour hospital. After visiting by a gastroenterologist, patients with IBS symptoms that has inclusion criteria and has fulfilled consent form would be randomly divided into two groups. Patients and researchers would be blind up to the end of the analysis
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-60 years constipation-predominant irritable bowel syndrome according to Rome IV criteria syndrome;
Exclusion criteria: pregnancy, and breastfeeding, hypothyroidism, having serious organic, or mental disorders, having other organic gastrointestinal disorders, use of medication that has an effect on bowel movements
Intervention groups
Patients are divided into two groups: Persian medicine remedy of Melissa officinalis, Rosa damascene, and Pimpinella anisum; placebo
Main outcome variables
IBS - Severity symptoms; quality of life of patients with IBS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150927024228N4
Registration date:2021-06-14, 1400/03/24
Registration timing:registered_while_recruiting
Last update:2021-06-14, 1400/03/24
Update count:1
Registration date
2021-06-14, 1400/03/24
Registrant information
Name
Maryam Azimi
Name of organization / entity
Kerman University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3312 2020
Email address
m_azimidehali@collegian.kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-07, 1400/03/17
Expected recruitment end date
2021-10-09, 1400/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of traditional Persian remedy of Melissa officinalis, Rosa damascena and Pimpinella anisum on clinical symptoms of patients with irritable bowel syndrome constipation-predominant (IBS-C).
Public title
Efficacy of traditional Persian remedy of Melissa officinalis, Rosa damascena and Pimpinella anisum on clinical symptoms of patients with irritable bowel syndrome constipation-predominant (IBS-C).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 years old patients with constipation-predominant irritable bowel syndrome according to Rome IV criteria.
Exclusion criteria:
Pregnancy, and breastfeeding
Hypothyroidism
Other organic gastrointestinal disorders such as Celiac, and inflammatory bowel disease
Use of other medication that has an effect on bowel movements
Having any serious organic or mental illnesses
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
According to block randomization, patients will be randomly entered into the study via blocks with size of 4 and 6, generated with Microsoft Excel® software. a trained secretory, who is blinded in details of the study, places patients in two groups based on these blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs are packaged into two groups (A and B) by a person that won't participate in the study. Patients, researchers, physicians, and all persons that participate in collecting, and analyzing data would be blinded. After analysis, the package contents will be announced. the herbal drug and placebo are prepared in the same package in terms of color, shape, and smell in the form of 500 mg capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Kerman University of Medical Sciences
At the beginning of the intervention, after 4 weeks, after 8 weeks
Method of measurement
IBS symptom severity score questionnaire
2
Description
Quality of life of IBS patients
Timepoint
At the beginning of the intervention, after 4 weeks, after 8 weeks
Method of measurement
Quality of life questionnaire of IBS patients
Secondary outcomes
empty
Intervention groups
1
Description
Aqueous extract of capsules of Melissa officinalis, and Pimpinella anisum; and Rosa damascene powder manufactured in the School of Pharmacy of Kerman University of Medical Sciences, three times a day, each time one 500 mg capsule, half an hour before each meal, with one glass of water, for one month
Category
Treatment - Other
2
Description
Corn Starch-containing capsules, manufactured in the School of Pharmacy of Kerman University of Medical Sciences, three times a day, each time one 500 mg capsule, half an hour before each meal with one glass of water, for one month