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the effect of an herbal Formula of Zizifus Jujuba as complementary treatment of elderly functional constipation

Protocol summary

Study aim
The aim of this study is to investigate the effectiveness of a product of jujube fruit, a plant native to Iran with nutritional value and laxative effect in the treatment of chronic constipation in the elderly.
Design
Clinical trial with control group, parallel groups, open label, randomized, phase 3 on 60 patients.
Settings and conduct
Patients over 60 years of age referring to the specialized clinics of Iran University of Medical Sciences located in Tehran, whose functional constipation has been approved by a respected gastroenterologist, will be included in the study.During the 4-week treatment period, the patients will be contacted and reminded by phone twice (once every 3 days).
Participants/Inclusion and exclusion criteria
People over the age of 60 whose functional constipation has been confirmed by a gastroenterology specialist based on Rome IV indicators; Not suffering from metabolic or endocrine diseases and any related organic disease With constipation; No use of alcohol and drugs that cause constipation; No history of allergy to fruit or jujube products or Pidrolox powder 5. No history of stomach and intestinal surgery; No severe mental illness, psychiatric disorders and neurological diseases; Having the ability to work Physical; No use of antibiotics in the last two weeks; No symptoms of viral gastroenteritis in the last 2 weeks; No malignancy; No abnormal Stool OB, FBS, TFT, Ca tests.
Intervention groups
Elderly over 60 years of age with functional constipation with nutritional and behavioral instructions and jujube product in the amount of two tablespoons every 12 hours on an empty stomach with a glass of warm water and Pidrolox powder in the amount of one 20 gram sachet of Pidrolox powder dissolved in 1 glass of water and 1 glass 2 Hour after breakfast
Main outcome variables
Number of bowel movements per week

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231022059800N1
Registration date: 2023-12-07, 1402/09/16
Registration timing: prospective

Last update: 2023-12-07, 1402/09/16
Update count: 0
Registration date
2023-12-07, 1402/09/16
Registrant information
Name
Fereshte Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3117
Email address
drfereshtefathi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-18, 1402/09/27
Expected recruitment end date
2024-05-16, 1403/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of an herbal Formula of Zizifus Jujuba as complementary treatment of elderly functional constipation
Public title
the effect of an herbal Formula of Zizifus Jujuba on elderly functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 60 years, when the presence of functional constipation based on Roman IV indicators has been confirmed by a respected gastroenterologist.
Exclusion criteria:
History of allergy to jujube fruit or jujube product or pidrolox powder. Use of anti-Parkinson drugs, anti-psychotics, tricyclic antidepressants, anti-convulsants, anti-cholinergics, anti-spasms, anti-neoplastic, calcium blockers, 5HT antagonists, iron products.Alcohol and drug abuse. Suffering from severe mental illness and psychiatric disorders. Suffering from neurological diseases such as multiple sclerosis, Parkinson's, progressive systemic sclerosis, spinal cord injury, stroke. Suffering from a metabolic disease such as uncontrolled diabetes, hypothyroidism, hypercalcemia, pheochromocytoma, and any organic disease related to constipation, severe asthma, and bronchitis. Cardiac and hematological patients in case of taking drugs that cause constipation, including calcium blockers, furosemide, iron products, opioids. Inability to do physical activity and having special medical conditions such as inability to move. History of intestinal or stomach surgery, ostomy. History of malignancy and cancer. Kidney and liver failure. Endoscopy, colonoscopy, and radiology report in the last 5 years that has any abnormality and malignancy or IBD. Stool has abnormal OB, FBS, TFT, Ca. Viral gastroenteritis symptoms in the last two weeks.
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 30
30 people in the intervention group and 30 people in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
The random block method will be used to allocate the samples to two groups. For this purpose, patients will receive number 1 to 60 according to their arrival. The randomization unit will be individually and by number with blocks of 4 people. The selection of the group type for each person will be done through random allocation 2 statistical software. In order to create a random sequence, codes A and B will be generated from the desired software, where code A will mean the application of the intervention group and code B will mean the application of the control group for each individual. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. As each patient enters, the doctor will open the envelope and apply the desired treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is conducted as an open label. Because the pharmaceutical forms are different and the two drugs are completely different in appearance, packaging, taste and way of consumption

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Mazandaran University of Medical Sciences
Street address
Ethic committee of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
48168-95474
Approval date
2023-10-24, 1402/08/02
Ethics committee reference number
IR.MAZUMS.REC.1402.439

Health conditions studied

1

Description of health condition studied
Functional constipation of the elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of bowel movements per week
Timepoint
Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention
Method of measurement
Asking the patient through a questionnaire

Secondary outcomes

1

Description
Feeling of incomplete emptying after defecation
Timepoint
Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention
Method of measurement
Questionnaire and questions from the patient

2

Description
number of times of manual maneuver in defecation
Timepoint
Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention
Method of measurement
Questionnaire and questions from the patient

3

Description
consistency of stool
Timepoint
Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention
Method of measurement
Questionnaire and questions from the patient

4

Description
the quality of life
Timepoint
Before the start of the intervention (beginning of the intervention) and days 28, 21, 14, after the intervention
Method of measurement
Quality of life questionnaire for functional constipation patients

Intervention groups

1

Description
Intervention group: Intervention group: Jujube-based traditional medicine product, two tablespoons every 12 hours on an empty stomach with a glass of warm water, for 4 weeks.
Category
Treatment - Drugs

2

Description
Control group: A 20 gram sachet of Pidrolox powder is dissolved in 1 glass of water and taken 1 glass daily 2 hours after breakfast for 4 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasul Akram Hospital clinic
Full name of responsible person
Fereshte Fathi
Street address
Tehran, Sattar Khan, Kh. Niayesh, Corner of Mansoori Street, Rasul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
Drfereshtefathi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saidi
Street address
Deputy of Research and Technology Mazandaran University of Medical Sciences, Moalem Ave., Moalem Square
City
Sari
Province
Mazandaran
Postal code
451533971
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
70
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
Mazandaran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 3117
Email
a.jokar@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr taghavi.shirazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Hassan Abad Square, Vahdat Eslami St., south side of Shahr Park, No. 847, beginning of Behesht St., Faculty of Iranian Medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Email
taghavi.shirazi.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fereshte Fathi
Position
Persian Medicine Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Center for Traditional Medicine and Complementary Medicine of mazandaran university; Khazar Boulevard, Khazar Square of Sari
City
Sari
Province
Mazandaran
Postal code
48168-95475
Phone
+98 11 3324 3117
Email
Drfereshtefathi@gmail.com

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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