Assessing the laxative effect of Laxactive (combination of pesilium and fig powder) in patients with constipation
Design
80 participants (no=40 per group) are randomly assigned to intervention and placebo group using random digit table
Settings and conduct
This double blinded study will be performed in private clinic. At base line Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire will be completed for each patient. after 2 weeks of intervention with supplement/placebo patients will complete PAC-SYM again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having constipation diagnosed by gastroenterologist based on Rome 3 criteria, Age>18 years, Willing to participate Exclusion criteria: having known kidney disease, having known heart disease, pregnancy or lactation
Intervention groups
Patients will receive 22 gram sachet containing 5 gram pesilium powder, 15 gram fig fruit powder, and 5 gram sorbitol (®Lax active, Sepid Teb) or similar amount of placebo 2 times daily, before lunch and dinner, each time 1 sachet for 2 weeks. Placebo capsule contain maltodextrine.
Main outcome variables
PAC-SYM score changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140804018677N23
Registration date:2022-07-26, 1401/05/04
Registration timing:registered_while_recruiting
Last update:2022-07-26, 1401/05/04
Update count:0
Registration date
2022-07-26, 1401/05/04
Registrant information
Name
soodeh razeghi Jahromi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
razeghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2022-11-06, 1401/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the laxative effect of Laxactive (combination of pesilium and fig powder) compared to placebo in patients with constipation
Public title
laxative effect of Laxactive (combination of pesilium and fig powder) in patients with constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having constipation diagnosed by gastroenterologist based on Rome 3 criteria
Age>18 years
Willing to participate
Exclusion criteria:
Pregnancy and lactation
Having known kidney disease
Having known heart disease
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 80 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code (supplement and placebo) at the time of sampling. The following groups of people involved in the trial: participants, Research team including principle investigator, data collectors, and outcome assessors will be blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Nutrition and Food Technology Research Institute
Street address
Hafezi Avenue, Farahzadi Blvd
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1401.022
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Gastrointestinal function
Timepoint
Before intervention and after 8 weeks of intervention
Method of measurement
Patient Assessment of Constipation-Symptoms questionnaire score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 22 gram sachet containing 5 gram pesilium powder, 15 gram fig fruit powder, and 5 gram sorbitol (®Lax active, Sepid Teb) two times daily before lunch and dinner for 2 weeks
Category
Treatment - Other
2
Description
Control group: 22 gram sachet of placebo (®Lax active, Sepid Teb) containing maltodextrin two times daily before lunch and dinner for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
private clinic
Full name of responsible person
Soodeh Razeghi Jahromi
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sepid Teb company
Full name of responsible person
Roya Pourshaghaghi
Street address
No 25, 6th alley, 16 St, Khaled-Estanboli St
City
Tehran
Province
Tehran
Postal code
1511765613
Phone
+98 21 2774
Email
info@sepidteb.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sepid Teb company
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
4741-19395
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
4741-19395
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
4741-19395
Phone
+98 21 2235 7583
Email
soodehrazeghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data would be available to public
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
To all
Under which criteria data/document could be used
No other criteria
From where data/document is obtainable
Email to soodehrazeghi@gmail.com
What processes are involved for a request to access data/document