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General information
IRCT20160306026938N13
IRCT20160306026938N14
IRCT20160306026938N13IRCT20160306026938N14
2022-10-18, 1401/07/26
2022-10-18, 1401/07/26
2022-10-18 22:34:5556
Protocol summary
Study aim
The effect of fig fruit and kiwi extract on constipation.
Design
Clinical trial with control and parallel groups, single-blinded, randomized, in 2 phase, has been conducted on 70 patients. RAND function in Excel software has been used for randomization purposes.
Settings and conduct
The clinical trial has been conducted in 2 phase on 70 patients with constipation referring to gastroenterology clinic of Imam Khomeini Hospital. The study is single-blinded and only the subjects have been put blind.
Participants/Inclusion and exclusion criteria
Compliance with Constipation diagnostic criteria, the age range is 18-70 years. Signing the informed consent. Exclusion criteria: Pregnancy, lactation, the existence of underlying illnesses, allergy to fig and kiwi, consumption of Constipation improvement medicines.
Intervention groups
Intervention group: Oral prescription of a syrup containing extract of fig fruit and kiwi, made in Pharmacognosy laboratory of Tehran's University of Medical Science, administered on 35 Constipation patients, two times a day (morning-.evening), for a one-month period.
Control group: Oral prescription of a Lactulose syrup administered on 35 Constipation patients, two times a day (morning-evening), for a one month period.
Main outcome variables
Constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160306026938N14
Registration date:2022-10-18, 1401/07/26
Registration timing:prospective
Last update:2022-10-18, 1401/07/26
Update count:1
Registration date
2022-10-18, 1401/07/26
Registrant information
Name
Mahdi Vazirian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6412 1223
Email address
vazirian_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of syrup containing extract of Fucus carica and Actinidia deliciosa in patients with constipation
Public title
The effect of fig fruit and kiwi extract on constipation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being afflicted with constipation
Age range of 18-70 years old
Signing the informed consent
Exclusion criteria:
Being afflicted with any underlying disease
Pregnancy
Being allergic to fig and kiwi.
Lactation periode
Consumption of medications for improvement of constipation
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 70 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 35 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 70.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the participants were not informed about receiving either treatment/placebo capsules. Thus, the study is a single-blinded one. The subjects in this study were not either relatives or friends, thus they couldn't compare the impacts of receiving placebo/treatment. In addition, the appearance of the syrups and their containing package was exactly similar in both Intervention/control group and is not differentiated. All the study subjects received a good deal of information regarding the research plan and have been presented to them .After being randomized through the use of statistical software package, treatment/placebo has been provided for them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethichs Committees of The Institute of Pharmaceutical Sciences- Tehran University Of Medica
Street address
16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-09-04, 1401/06/13
Ethics committee reference number
IR.TUMS.TIPS.REC.1401.045
Health conditions studied
1
Description of health condition studied
Constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Constipation
Timepoint
After intervention
Method of measurement
Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms(0=no improvement; 10= complete improvement)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral prescription of a syrup containing extract of fig fruit and kiwi, made in Pharmacognosy laboratory of Tehran's University of Medical Science, administered on 35 Constipation patients, two times a day (morning-evening), for a one-month period.
Category
Treatment - Drugs
2
Description
Control group: Oral prescription of a Lactulose syrup administered on 35 Constipation patients, two times a day (morning-evening), for a one month period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology clinics of Imam Khomeini hospital