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Comparison The Efficacy of Iranian Traditional Aloe Vera based Formula and Poly Ethylene Glycol on adult functional constipation

Protocol summary

Summary
(1) Objectives: Basic goal: Comparison of The Efficacy of Iranian Traditional Aloe Vera based Formula and Poly Ethylene Glycol on adult functional constipation; Special goals: Effect of Iranian Traditional Aloe Vera based Formula & Poly Ethylene Glycol on frequency of bowel movements per week, straining, stool consistency, sense of incomplete evacuation, need to manually maneuver for evacuation and time of defecation after consuming drug in adults with chronic constipation. (2) Design: Randomized Clinical Trial. (3) Setting and conduct: Patients with chronic functional constipation are referred by gastroenterologist to traditional medicine clinic. Then, patients are divided in two groups: Poly Ethylene Glycol and Traditional Aloe Vera based Formula. In first visit, PhD student of Traditional medicine complete consent form, standard constipation’s questionnaire based on ROM III criteria and educate drug instructions to patients. Constipation’s questionnaire should be complete again in 14 and 28 days after drug consumption. Patients consume drugs only for first 14 days, and don’t consume any drug for second 14 days later (off period). Finally, all data are collected and analyzed statistically. (4) Participants including major eligibility criteria: Inclusion criteria: Age more than 18 years; have chronic functional constipation based on ROM III criteria. Exclusion criteria: Drug induced constipation; Intestinal mechanical or pseudo obstruction; Metabolic & Endocrine disorders; Pregnancy & Lactation; Neurologic & myopathic disorders; IBS; Malignancy; Previous history of GI surgery. (5) Intervention: Intervention group one: Iranian traditional Aloe Vera Based formula, cap: 500 mg, 1-2 cap per day before sleeping with 1 glass of hot water for 14 days and Intervention group two: Poly Ethylene Glycol powder, 15 - 20 gram per day with 1 glass of water/juice, 1 hour after breakfast, for 14 days (6) Main outcome measures (variables): Frequency of defecation per week.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013112915584N1
Registration date: 2014-03-01, 1392/12/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-01, 1392/12/10
Registrant information
Name
Assie Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3117
Email address
arezoo2003dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iranian Traditional Medicine Faculty of Tehran University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The Efficacy of Iranian Traditional Aloe Vera based Formula and Poly Ethylene Glycol on adult functional constipation
Public title
Comparison The Efficacy of Iranian Traditional Aloe Vera based Formula and Poly Ethylene Glycol on adult functional constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18 years; have chronic functional constipation based on ROM III criteria. Exclusion criteria: Drug induced constipation; Intestinal mechanical or pseudo obstruction; Metabolic & Endocrine disorders; Pregnancy & Lactation; Neurologic & myopathic disorders; IBS; Malignancy; Previous history of GI surgery.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Committee of Tehran University of Medical Sciences
Street address
Research Institute for Islamic and Complementary Medicine, Pyrnia Alley, Lalezarno Ave., Jomhouri Eslami St.
City
Tehran
Postal code
Approval date
2013-05-27, 1392/03/06
Ethics committee reference number
112/ط/م/26پ

Health conditions studied

1

Description of health condition studied
Functional chronic constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation

Primary outcomes

1

Description
Frequency of defecation per week
Timepoint
0:Before intervention, 14: 14 days after consuming drug, 28: 14 days without any drug (off period)
Method of measurement
Questionnaire

2

Description
Fecal shape & consistency
Timepoint
0:Before intervention, 14: 14 days after consuming drug, 28: 14 days without any drug (off period)
Method of measurement
Questionnaire

3

Description
Defecation time after drug consumption
Timepoint
0:Before intervention, 14: 14 days after consuming drug, 28: 14 days without any drug (off period)
Method of measurement
Questionnaire

4

Description
Sensation of incomplete evacuation
Timepoint
0:Before intervention, 14: 14 days after consuming drug, 28: 14 days without any drug (off period)
Method of measurement
Questionnaire

5

Description
Straining during defecations
Timepoint
0: before intervention, 14: 14 days after using drug, 28: 14 days without any drug (off period)
Method of measurement
Questionnaire

6

Description
Manual maneuvers to facilitate defecations
Timepoint
0:Before intervention, 14: 14 days after consuming drug, 28: 14 days without any drug (off period)
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Iranian traditional Aloe Vera Based formula, cap: 500 mg, 1-2 cap before sleeping with 1 glass of hot water, during 14 days
Category
Treatment - Drugs

2

Description
Intervention group 2: Poly Ethylene Glycol powder, 15 - 20 gr with 1 glass of water/juice, 1 hour after breakfast meal, during 14 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafavian Subspecialty Clinic of Imam Khomeini Hospital
Full name of responsible person
Dr Marjan Mokhtare
Street address
Imam Khomeini Hospital of Sari
City
Sari

2

Recruitment center
Name of recruitment center
Iranian Traditional Medicine Clinic of Buali Sina Hospital
Full name of responsible person
Dr Assie Jokar
Street address
Buali Sina Hospital of Sari.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Iranian Traditional Medicine Faculty of Tehran University of Medica
Full name of responsible person
Mohammad Bagher Minaei
Street address
Traditional Medicine Faculty of Tehran Medical University; Behesht st., Vahdat Eslami Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Iranian Traditional Medicine Faculty of Tehran University of Medica
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
PhD student of Iranian Traditional medicine
Other areas of specialty/work
Street address
Traditional medicine Clinic of Buali Sina Hospital
City
Sari
Postal code
Phone
+98 151223301216
Fax
Email
arezoo2003dr@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Omid Sadeghpour
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Institute for Islamic and Complementary Medicine, Pyrnia Alley, Lalezarno Ave., Jomhouri Eslami St.
City
Tehran
Postal code
Phone
+98 21 3311 1619
Fax
Email
tndic@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Assie Jokar
Position
PhD student of Iranian Traditional medicine
Other areas of specialty/work
Street address
Traditional Medicine Faculty of Tehran University of Medical Sciences; Behesht st., Vahdat Eslami Ave.
City
Tehran
Postal code
Phone
+98 21 5561 3191
Fax
Email
a-jokar@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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