The study is accomplished as a pilot before-after clinical trial without control group.
The goals of the study are determination of effect of Maqliasa on severity of symptoms in ulcerative colitis, probable side effects and determination of conditions for a double blind RCT.
Study population is the admitted outpatients to GI clinic of Rasoul Akram hospital and Tehran university of medical sciences clinic of traditional medicine. The diagnosis is done via colonoscopy by gastroenterologist.
Inclusion criteria are age between 18 to 70 y/o, no history of peptic ulcer, no history of toxic megacolon, and no history of colon cancer.
Exclusion criteria are: appearance of peptic ulcer manifestations and emergence of severe drug complications. The patients fill the written consent form. Also, conditions of the research will be explained.
The patients undergo a 28-day trial with the drug "Maqliasa". Three visits are accomplished for each patient; First admission, 14 days later and 28 days later. At the first admission, after a disease evaluation by ulcerative colitis disease activity index, the needed drug is rendered to the patients for 14 days. At the 2nd visit, changes in the manifestations will be evaluated by the above-mentioned index. Then, the rest of the drug will be rendered. At the third visit changes will be evaluated again for the third time. After data gathering, analysis with SPSS will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042719489N2
Registration date:2017-07-09, 1396/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-09, 1396/04/18
Registrant information
Name
Meysam Shirzad
Name of organization / entity
School of traditional medicine, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4535
Email address
shirzad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Barij Essence Pharmaceutical Company
Expected recruitment start date
2017-06-11, 1396/03/21
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Maqliasa - a traditional Persian medicine formulation on ulcerative colitis: A pilot clinical study
Public title
Effect of Maqliasa capsule on ulcerative colitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- The study is accomplished in patients suffer from ulcerative colitis confirmed by colonoscopy
2- Age limit between 18 to 70 y/o
3- No pregnancy
4- No breastfeeding
5- No history of peptic ulcer
6- No history of toxic megacolon
7- No history of colon cancer
Exclusion criteria:
1- Appearance of peptic ulcer manifestations
2- Emergence of severe drug complications
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods St, Keshvarz Blv
City
Tehran
Postal code
Approval date
2017-06-10, 1396/03/20
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2559
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Diarrhea (Number of daily stools)
Timepoint
Onset of intervention, 14 and 28 days later
Method of measurement
Patient statements
2
Description
Nocturnal diarrhea
Timepoint
Onset of intervention, 14 and 28 days later
Method of measurement
Patient statements
3
Description
Fecal incontinence
Timepoint
Onset of intervention, 14 and 28 days later
Method of measurement
Patient statements
4
Description
Abdominal pain or cramping
Timepoint
Onset of intervention, 14 and 28 days later
Method of measurement
Patient statements
5
Description
General well-being
Timepoint
Onset of intervention, 14 and 28 days later
Method of measurement
Patient statements
6
Description
Abdominal tenderness
Timepoint
Onset of intervention, 14 and 28 days later
Method of measurement
Physical exam
7
Description
Need for anti-diarrhea drugs
Timepoint
Onset of intervention, 14 and 28 days later
Method of measurement
Patient statements
Secondary outcomes
1
Description
Adverse drug reactions
Timepoint
Days 14th and 28th
Method of measurement
Patient statements
Intervention groups
1
Description
Herbal product capsules called "Maqliasa"
-2 capsules three times daily orally for intervention group
-There is no control group
-Duration of intervention: 28 days
-Manufacturer: Barij Essence Pharmaceutical Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram general hospital, GI clinic
Full name of responsible person
Dr. Shahram Agah
Street address
Niayesh St., Satarkhan St.
City
Tehran
2
Recruitment center
Name of recruitment center
Tehran university of medical sciences clinic of traditional medicine (Ahmadie)
Full name of responsible person
Dr. Meysam Shirzad
Street address
No. 27, Sarparast St., Taleqani Ave.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barij Essence Pharmaceutical Co.
Full name of responsible person
Mrs. Laleh Hejazi
Street address
P.O. Box: 1178, Mashad Ardehal
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barij Essence Pharmaceutical Co.
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
Alborz university of medical sciences
Full name of responsible person
Dr. Mohammadmahdi Ahmadian-Attari
Position
PhD in Traditional Pharmacy
Other areas of specialty/work
Street address
No. 132, Marzdaran St.
City
Tehran
Postal code
Phone
+98 21 4427 1724
Fax
Email
ahmadian-attari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Meysam Shirzad
Position
Assistant professor- Specialist in traditional medicine
Other areas of specialty/work
Street address
No.27, Sarparast Ave., Taleqani St., Tehran, Iran
City
Tehran
Postal code
Phone
0088993656
Fax
Email
shirzadmd@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Meysam Shirzad MD, PhD
Position
Assistant Professor- Specialist in traditional medicine
Other areas of specialty/work
Street address
No.27, Sarparast Ave., Taleqani St.
City
Tehran
Postal code
Phone
00
Fax
Email
shirzadmd@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)