The effect of Kaaser capsule (Zingiber Officinale, Carum Capticum, Piper Nigrum) on functional bloating and comparison with Dimethicone capsule; Clinical Control Trial.
The purpose of the study is to compare the effect of "Kaaser" capsule
(Zingiber Officinale, Carum Capticum, Piper Nigrum) with Dimethicone capsule and placebo on functional bloating. One hundred twenty 20-50 years old patients who recourse Ayatollah Rouhani hospital with considering inclusion and exclusion criteria, will enter the study. Enrolling in 3 groups of "Kaaser" capsule, Dimethicone capsule, and placebo cases will be done with simple sampling and random allocation. Design and performance of the study are double blind.The cases are obtained written informed consent and will explain them that enrolling in the groups is randomly.The forms of demographic information will be completed and also severity and frequency of bloating and early satiety (based on Visual Analogue Scale) before enrolling in to the study.Drugs in 3 groups will given in 500 mg capsules TDS.Severity and frequency of Bloating will evaluated,2weeks after starting the study and 2 weeks and 2 months after finishing the study. And early satiety will evaluate 2 weeks of starting the study and those will written and compared with the baseline data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100324327N1
Registration date:2016-01-13, 1394/10/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-13, 1394/10/23
Registrant information
Name
Zeinab Mahmoudpour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4730
Email address
z.mahmoudpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol university of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Kaaser capsule (Zingiber Officinale, Carum Capticum, Piper Nigrum) on functional bloating and comparison with Dimethicone capsule; Clinical Control Trial.
Public title
The effect of of Kaaser capsule (Zingiber Oficinale, Caum Capticum, Piper Nigrum) on bloating.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 20 to 50 years, symptoms of bloating: feeling of abdominal distention, increasing of abdominal gas in the last three months with symptom onset at least six months prior to the study, three days a week؛ Exclusion criteria :I.B.D on colonoscopy, Diabetes, Anemia, Hypothyroidism, Celiac, Kidney disease,use of any treatment of bloating on during the study.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol university of medical science Ethics.
Street address
Babol- Ganjafrooz street- university of Babol
City
Babol
Postal code
47745-47176
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
MUBABOL.REC.1394.233
Health conditions studied
1
Description of health condition studied
Bloating
ICD-10 code
R14
ICD-10 code description
Flatulence and related conditions
Primary outcomes
1
Description
severity of bloating
Timepoint
before study, two weeks after starting the study, two weeks and two months after finishing the study
Method of measurement
Visual Analogue Scale
2
Description
Frequency of bloating
Timepoint
Befor study,two weeks after starting the study,two weeks and two mounths after finishing the study