Ultrasonographic study of the effects of the herbal medicine package on the size of fibroma
Design
The study of the two-course clinical trial of 60 patients was randomly divided into 2 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients with With fibroids in Arak radiology clinic in Arak are divided into 2 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:15 to 49 years, having a uterine fibroid smaller millimetre, no history of uterine cancer in the individual and first-degree relatives, no pregnancy, no breastfeeding, lack of uterine bleeding, colitis, hemorrhoids, appendicitis, intestinal obstruction, acute inflammatory bowel diseases such as Crohn's disease, ulcerative colitis, abdominal pain of unknown origin, gastric bleeding and esophageal varices
Absence of underlying disease
Exclusion criteria:Dissatisfaction
Intervention groups
Intervention group: One capsule of Iarj Fiqra 500 milligram at the end of the night with warm water and soda soda as a decoction in the morning and night (half an hour before breakfast and the night before bed take a bag of medicine in a glass of water for 10 minutes Boil over low heat and drink until hot.
Control group: placebo, which is in the form of a capsule similar to Iraj Fiqra medicine (in coordination with the pharmaceutical company, is poured into capsules similar to Iraj Fiqra flour) and black tea tea is used to replace placebo for soda.
Main outcome variables
Fibroma size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N147
Registration date:2020-07-14, 1399/04/24
Registration timing:registered_while_recruiting
Last update:2020-07-14, 1399/04/24
Update count:0
Registration date
2020-07-14, 1399/04/24
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasonographic study of the effects of the herbal medicine package on the size of fibroma
Public title
Ultrasonographic study of the effects of the herbal medicine package on the size of fibroma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
15 to 49 years
Having a uterine fibroid smaller millimetre
No history of uterine cancer in the individual and first-degree relatives
No pregnancy
No breastfeeding
Lack of uterine bleeding, colitis, hemorrhoids, appendicitis, intestinal obstruction, acute inflammatory bowel diseases such as Crohn's disease, ulcerative colitis, abdominal pain of unknown origin, gastric bleeding and esophageal varices
Absence of underlying disease
Exclusion criteria:
Dissatisfaction
Age
From 15 years old to 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with randomization with envelopes in 2 groups A and B.
In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.ARAKMU.REC.1399.091
Health conditions studied
1
Description of health condition studied
Uterine fibroids
ICD-10 code
O34.1
ICD-10 code description
Maternal care for benign tumor of corpus uteri
Primary outcomes
1
Description
Fibroma size
Timepoint
Before and after three months of treatment
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One capsule of Iarj Fiqra 500 milligram at the end of the night with warm water and soda soda as a decoction in the morning and night (half an hour before breakfast and the night before bed take a bag of medicine in a glass of water for 10 minutes Boil over low heat and drink until hot.
Category
Treatment - Drugs
2
Description
Control group: placebo, which is in the form of a capsule similar to Iraj Fiqra medicine (in coordination with the pharmaceutical company, is poured into capsules similar to Iraj Fiqra flour) and black tea tea is used to replace placebo for soda.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private outpatient Radiology Clinic
Full name of responsible person
Dr Fatemeh Safi
Street address
Shariati squre,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
f.safi@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
aliakamliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Emam reza clinic, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
m.salehi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Fatemeh Safi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Radiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street