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The Efficacy of Habb-e Jalinous and Psyllium compared with Placebo and Psyllium on adult functional constipation: A double blinded clinical trial

Protocol summary

Study aim
Effect of Jalinous tablet in the treatment of functional constipation symptoms
Design
About 126 patients refer to GI Clinic of Imam Khomeini Hospital, enroll the study. It is double-blinded clinical trial. They will randomly divide into 2 groups: Jalinous and Psyllium; Placebo and Psyllium by computer-based randomization method. Questionnaires will be asked based on ROME IV, ODS and Bristol Stool Scale, Initially, day 14 and 28. Intervention time is 1 month
Settings and conduct
Patients having functional constipation according to Rome IV Criteria refer to GI Clinic of Imam Khomeini Hospital of Tehran University
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-50 years, Ability to understand and answer questions, Qualified for ROME IV functional constipation, Confirmed functional constipation diagnosis by GI specialist, Non-pregnancy and lactation, Completing consent form. Exclusion criteria: Diseases may lead to hospitalization or medication, Use other laxatives in study more than 2 times a week, Addiction, Alarm signs, Severe side effect, Patient's unwillingness to continue, No drug use more than 7days, Have a history of allergy to drug components, Use of drugs influence on bowel motility, Previous history of GI surgery
Intervention groups
Patients randomly divide into 2 groups: Jalinous tablet and Psyllium sachet; Placebo tablet and Psyllium sachet.They take a Psyllium sachet in a glass of water every morning and 2 Jalinous tablet with warm water before bed; instead, the other; 2 Placebo tablet with warm water at bed
Main outcome variables
Changes in severity of functional constipation symptoms will be measured based on ROME IV and ODS questionnaire: frequency of bowel movements, changes in frequency of hard stool, incomplete defecation, use of manual maneuvers, straining and stool consistency based on Bristol at 0,14, 28 days of intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190312043025N1
Registration date: 2020-01-20, 1398/10/30
Registration timing: retrospective

Last update: 2020-01-20, 1398/10/30
Update count: 0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
shahdis barimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4436 7873
Email address
sbarimani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-22, 1397/11/02
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Habb-e Jalinous and Psyllium compared with Placebo and Psyllium on adult functional constipation: A double blinded clinical trial
Public title
The Efficacy of Jalinous tablet compared with Placebo on adult functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 50 years old Ability to understand, speak and answer the questions Qualified for ROME IV functional constipation Confirmed functional constipation diagnosis by gastrointestinal specialist Non-pregnancy and lactation Complete the consent form
Exclusion criteria:
New disease that may lead to hospitalization or new medications Use other laxatives when studying more than 2 times a week Drug Addiction Alarm signs (rectal bleeding, fever, loss of appetite, weight loss, ...) Incidence of severe side effect of the study drug The patient's unwillingness to continue participating in the study for any reason No regular drug use (more than 7 days) Have a history of allergy to aloe Vera, rose, Indian Jalap and mastic Recent use of antacid, anticholinergic, anti Parkinson, anti psychotic and tricyclic antidepressants, anticonvulsants, antidepressants, diuretics and calcium blockers, iron products, opioids, calcium, prophylaxis Contains progesterone Previous history of any abdominal and gastrointestinal surgery
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Patients eligible for inclusion criteria, by using balanced the block randomization with Excel computer software, will randomly be divided into two groups: A: Jalinous tablet and Psyllium sachet, B: Placebo tablet and Psyllium sachet
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs will be packaged in two groups (A and B) by a person whom won't participate in study. Patients, physicians and all person that participate in collecting data would be blinded. After analysis, the contents of the package will be announced.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Science, Imam Hussein Square, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.SUMS.MED.REC.1397.471

Health conditions studied

1

Description of health condition studied
Functional Constipation
ICD-10 code
K59.00
ICD-10 code description
Constipation, unspecified

Primary outcomes

1

Description
Changes in frequency of defecation
Timepoint
Before intervention and after 14 and 28 days of treatment
Method of measurement
Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner.We will evaluate the frequency of defecation as per week.

2

Description
Changes in incomplete defecation and evacuation
Timepoint
Before intervention and after 14 and 28 days of treatment
Method of measurement
Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of incomplete defecation from 0-100 (never to always)

3

Description
Changes in straining
Timepoint
Before intervention and after 14 and 28 days of treatment
Method of measurement
Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of straining from 0-100 (never to always).

4

Description
Changes in using of manual maneuver
Timepoint
Before intervention and after 14 and 28 days of study
Method of measurement
Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of manual maneuver from 0-100 (never to always).

5

Description
Changes of hard stool
Timepoint
Before intervention and after 14 and 28 days of study
Method of measurement
Symptoms of constipation will be assessed using an investigator generated questionnaire based on the Rome IV criteria and ODS questioner. We will evaluate the percent of hard stool from 0-100 (never to always)

Secondary outcomes

1

Description
Changes in stool consistency
Timepoint
According to Bristol stool scale, at baseline, week 2 and 4
Method of measurement
The Bristol stool scale will be used to specify the stool forms: types 1 and 2 considered as hard, 3 and 4 as normal and 5 to 7 as loose stool. Overall improvement in each symptoms will be assessed and categorized as complete or partial improvement, same and worse.

2

Description
Overall self-reported improvement in symptoms after treatment
Timepoint
At the end of intervention
Method of measurement
After intervention based on patients attitude, Using the options of: deterioration, unchanged, partial recovery and complete recovery

3

Description
Side effects
Timepoint
At the end of week 2 and 4
Method of measurement
Using the check lists

Intervention groups

1

Description
Intervention group: every morning when fasting, patients using a 10 gram Psyllium granule sachet; manufactured by Dineh company with registration code 6911052432012790 witch made from Plantago Psyllium seed; in a glass of water, and take two Jalinous tablet (Habbe - Rahat), licensed to administer natural, traditional and complementary products No.s-0212-92, containing: mastic, Aloe Vera, Rose, Indian Jalap, with warm water before bed.
Category
Treatment - Drugs

2

Description
Control group: Patients, take a 10 gram Psyllium granule sachet; manufactured by Dineh company with registration code 6911052432012790 witch made from Plantago Psyllium seed; in a glass of water, every fasting morning, and take two Placebo tablets containing starch powder with warm water before bed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Gastrointestinal disease of Imam Khomeini Hospital
Full name of responsible person
Barimani Shahdis
Street address
End of Keshavarz Blvd., Dr.Gharib Street, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2281
Email
Imamhospital@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghasemi Younes
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Next to the Red Crescent, Zand St
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
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

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Barimani Shahdis
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz University of Medical Science, Imam Hossein Square, Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3234 5145
Email
sbarimani@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Barimani Shahdis
Position
Student of PhD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz University of Medical Science, Imam Hussein Square, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3234 5145
Email
sbarimani@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Barimani Shahdis
Position
Student of PhD
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shiraz University of Medical Science, Imam Hussein Square, Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3234 5145
Email
sbarimani@sums.ac.ir

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
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