Protocol summary
-
Study aim
-
Determining the efficacy of Persian medicine remedy of Melissa officinalis, Rosa damascene, and Pimpinella anisum in patients with constipation-predominant Irritable Bowel Syndrome compared with placebo.
-
Design
-
Phase 3 controlled clinical trial with a parallel design, double-blind, blocked randomization, with a sample size of 96 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, severe complications related to this study, use of other effective drugs on irritable bowel syndrome (symptoms, quality of life, anxiety, and depression)
-
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
-
Update information (final sample size, outcomes, intervention details,...)
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20150927024228N4
Registration date:
2021-06-14, 1400/03/24
Registration timing:
prospective
Last update:
2024-02-03, 1402/11/14
Update count:
1
-
Registration date
-
2021-06-14, 1400/03/24
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-10-07, 1400/07/15
-
Expected recruitment end date
-
2022-05-09, 1401/02/19
-
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 in 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
Severe complications related to this study
use of other effective drugs on irritable bowel syndrome (symptoms, quality of life, anxiety, and depression)
-
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:
96
-
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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-05-06, 1398/02/16
-
Ethics committee reference number
-
IR.KMU.AH.REC.1398.214
Health conditions studied
1
-
Description of health condition studied
-
Irritable Bowel Syndrome
-
ICD-10 code
-
K58.9
-
ICD-10 code description
-
Irritable bowel syndrome without diarrhea
Primary outcomes
1
-
Description
-
IBS symptom severity score
-
Timepoint
-
At the beginning of the intervention, after 4 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
-
Method of measurement
-
Quality of life questionnaire of IBS patients
3
-
Description
-
Anxiety and depression
-
Timepoint
-
At the beginning of the intervention, after 4 weeks
-
Method of measurement
-
Anxiety and depression questionnaire
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, two 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, two 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
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kerman University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available