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Comparative study on the effectiveness of Golghand (Persian traditional medicine product) with magnesium hydroxide in the improvement of adalt constipation

Protocol summary

Study aim
Compare the frequency of defecations in both groups before the starting of the Intervention.
Design
Randomized clinical trial with parallel groups, control group, blindness has not been performed Sample size: Two groups of 28 people
Settings and conduct
Procedure: Patients complained of chronic constipation will be included in the study after receiving sufficient information and obtaining consent. In the first visit, the consent form, the demographic questionnaire and the checklist for Gastrointestinal mezaj form are completed for patients. Patients were divided into two groups based on random blocks: A-Common Medicinal Treatments (Magnesium Hydroxide) B-Treatment with Golghand Potion In the first two weeks, patients will take medication and in the second two weeks, patients should discontinue the medication and be monitored without medication. This study was conducted at Sayyad Hospital in Gorgan.
Participants/Inclusion and exclusion criteria
Inclusion criterias: age over 20, Roman criterias 3, no laxative, patient satisfaction - Exclusion criterias: use of other medications, history of any systemice and metabolic diseases
Intervention groups
The intervention is divided into two groups of 28 people. 28 people will use golghand and 28 people will use magnesium syrup.
Main outcome variables
Frequency of defecation ;The amount of straining in the defecation; Frequency of Lumpy or hard stool; Sensation of incomplete evacuation after defecation;use the Manual maneuvers to facilitate in defecation ; Occurrence of stool; Other Symptoms ; side effect

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180114038354N1
Registration date: 2019-07-21, 1398/04/30
Registration timing: registered_while_recruiting

Last update: 2019-07-21, 1398/04/30
Update count: 0
Registration date
2019-07-21, 1398/04/30
Registrant information
Name
Ghorbanoghli Sayeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3232 8111
Email address
dr.ghorbanoghli@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effectiveness of Golghand (Persian traditional medicine product) with magnesium hydroxide in the improvement of adalt constipation
Public title
The effect of Golghand in the improvement of constipation in adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria : 1-age over 20 years 2. Have at least 2 of the following criteria; - Straining during at least 25 percent of defecations - Lumpy or hard stools in at least 25 percent of defecations -Sensation of incomplete evacuation for at least 25 percent of defecations -Sensation of anorectal obstruction/blockage for at least 25 percent of defecations -Manual maneuvers to facilitate at least 25 percent of defecations -Fewer than three defecations per week 3. during the last month,Without the use of laxatives, rarely have soft stool 4. Patient satisfaction to participate in the study
Exclusion criteria:
Exclousion criterias: 1- Use medications Anti-seizures, Carbamazepine, Phenobarbital, Phenytoin, Anti-neoplastic, Calcium channel blockers: Verapamil, Diuretics: Forzamide, Anti-epileptic drugs, Anti-epileptic drugs, Anti-epileptic drugs. , 5-HT antagonists, NSAIDs: ibuprofen, opioid. 2. History of mechanical and False intestinal obstruction based on previous colonoscopy or radiography or history 3 - Metabolic and endocrine diseases such as Diabetes, Hyperthyroidism and Hypothyroidism, Hypercalcemia, Hypokalemia, Pan-Hypopyothelium, Pheochromocytoma, Porphyria 4. Neurological disease and myopathic amyloidosis, autonomic neuropathy, Chagas disease, dermatomyositis, multiple sclerosis, Parkinson's disease, systemic progressive sclerosis, spinal cord injury based on biography and history 5-Special surgical and special medical conditions such as inability to move, history of Intestine surgery, ... 6. Endoscopy and radiology report in the last 5 years on abnormalities, malignancy, IBD and hemorrhoids 7-Patients with abnormal Hgb, TFT, Ca, and ESR. 8-Patients with HTN or Diabetes 9 -Patients with Asthma and Bronchitis 10.-Patients with Renal failure 11. Pregnant and nursing women
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
The initial selection of the samples will be available as a sampling from among the people referring to the Sayyid Gorgan educational center and observing the entry criteria. The allocation of 56 people to two groups of 28 was random
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commeitee of Gorgan university of medical scinces
Street address
No 114,Dokhniyat 3 , Dokhaniyat blvd, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4917953776
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.Goums.Rec.1397.276

Health conditions studied

1

Description of health condition studied
constipation in adult
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
Frequency of defecation in the week
Timepoint
Frequency of defecation in the subjects before the internvention and in the 14th day and 28th day after startinig intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
The amount of straining in the defecation
Timepoint
Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention
Method of measurement
questionnaire

2

Description
Frequency of lumpy or hard stools
Timepoint
Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention
Method of measurement
questionnaire

3

Description
Sensation of incomplete evacuation after defecation
Timepoint
Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention
Method of measurement
questionnaire

4

Description
frequency of Manual maneuvers to facilitate
Timepoint
Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention
Method of measurement
questionnaire

5

Description
Occurrence of stool
Timepoint
Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention
Method of measurement
questionnaire

6

Description
Other related symptoms
Timepoint
Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention
Method of measurement
questionnaire

7

Description
side effect
Timepoint
Before the beginning of the Intervention and in the 14th day and 28th day after starting the Intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: They will use Golghand, Golghand is an Iranian traditional medicinal that consists of rose petals and honey, which is provide by Niaku Gorgan Pharmaceutical Company. The chemical composition of the analysis is as follows (100 grams of Golghand): 39.5 g (39%) regenerated Sugars - 19.5 g Sucrose (19%) - 10.2 g (10%) Fructose - 17.5 g total volatile oil 17%) - Geraniol 7 mg (007%) - Citroneulol 5 mg (005%) . The dosage is 20 grams daily for pationts.they use 10 grams before lunch and 10 grams before dinner with a glass of water. Patients will take medication for two weeks.
Category
Treatment - Drugs

2

Description
Control group: Participants in the control group will receive magnesium hydroxide syrup. This is provided from the Souha Pharmaceutical Company. this group receives magnesium syrup 40 cc (According to the standard dosage of 30-60 cc in Iran's generic drugs book) In two divided doses, morning (20 cc)and night Before sleeping (20 cc).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Sayyad Shirazi Medical Education Center
Full name of responsible person
Sayeh Ghorbanighli
Street address
Sayyad Shirazi Hospital, Sayyad Blvd
City
Gorgan
Province
Golestan
Postal code
4917952667
Phone
+98 17 3220 2291
Email
infosayyad@goums.ac.ir
Web page address
http://goums.ac.ir/index.php?gsmp

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Vice-chancellor of Research and Technology of Gorgan University
Street address
Vice-chancellor of Research and Technology, Gorgan University of Medical Sciences, 5 Km Gorgan, Sari Road
City
Gorgan
Province
Golestan
Postal code
4991555876
Phone
+98 17 3243 0310
Email
Info@goums.ac.ir
Web page address
http://goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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

Person responsible for general inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sayeh Ghorbanoghli
Position
Residense
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan university of medical science ,Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4917953776
Phone
+98 17 3255 6862
Email
dr.ghorbanoghli@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sayeh Ghorbanoghli
Position
residense
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan University of Medical Sciences, Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4917953776
Phone
+98 17 3255 6862
Email
dr.ghorbanoghli@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Sayeh Gorbanoghli
Position
Residense
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Gorgan University of Medical Sciences, Hirkan blve
City
Gorgan
Province
Golestan
Postal code
4917953776
Phone
+98 17 3255 6862
Email
dr.ghorbanoghli@goums.ac.ai

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information on the main outcomes and non-core outcomes will be published and analyzed and analyzed
When the data will become available and for how long
Start the access period after publishing the results
To whom data/document is available
all people
Under which criteria data/document could be used
There is no limit for using the results Naming resources
From where data/document is obtainable
Sayeh Ghorbanoghli dr.ghorbanoghli@goums.ac.Ir
What processes are involved for a request to access data/document
It will be answered as soon as possible
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