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Effects of oral administration of Carum Copticum product compared to placebo in reducing symptoms of bloating and flatulence

Protocol summary

Summary
This study evaluates the effects of oral administration of Carum Copticum product compared to placebo in reducing symptoms of bloating and Flatulence. This is a randomized, double-blind (meaning that neither the patients nor the researchers know who is getting a placebo and who is getting the treatment), placebo-controlled, phase one study.The study is done in Hazrate Rasule Akramh (PBUH) Hospital as well as the private clinics of gastroenterology. Inclusion criteria: age of 18 to 49 years, symptoms of flatulence, bloating or feeling of abdominal distention, normal abdominal examination, normal blood and stool tests. Exclusion criteria: History of chronic or structural disorders of the gastrointestinal tract, serious clinical conditions, diabetes, thyroid gland disease, serious systemic disease, uncontrollable high blood pressure, major psychiatric disorders, diagnosis of lactase deficiency or relieving symptoms by lactase free diet, alarm signs, gastrointestinal surgery, masticatory disorders, cancer, drugs affecting the movement of the digestive tract two weeks before and during the study, taking antibiotics one month before starting the study, drug or alcohol abuse, lactating and pregnant women. Sample size would be 108 patients. The intensity and frequency of the symptoms including bloating, belching, abdominal sounds, abdominal pain, flatulence, flatus incontinence as well as possible drug side effects will be obtained for each patient in three times including the admission phase, four weeks after treatment and four weeks after finishing the treatment. Symptoms will be assessed using the Likert scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013091614679N1
Registration date: 2013-11-08, 1392/08/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-11-08, 1392/08/17
Registrant information
Name
Maryam Yazdian
Name of organization / entity
Traditional Medicine Faculty of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2612 3341
Email address
ma_yazdian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of oral administration of Carum Copticum product compared to placebo in reducing symptoms of bloating and flatulence
Public title
Carum Copticum effect in the treatment of bloating
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 49 years, symptoms of flatulence, bloating or feeling of abdominal distention in the last three months with symptom onset at least six months prior to the study, normal abdominal examination, normal blood and stool tests including CBC, ESR, TSH, Ca, P, ALT, AST, Alph, BUN, Cr, FBS, TTGA, Stool exam (OB, OP, Leukocyte). Exclusion criteria :History of chronic or structural disorders of the gastrointestinal tract such as irritable bowel disease, peptic or duodenal ulcer disease, gastrointestinal obstruction, symptomatic gallbladder stone, serious clinical conditions, diabetes, thyroid gland disease, serious systemic disease (including heart , renal , lung and liver failure), uncontrollable high blood pressure, major psychiatric disorders, diagnosis of lactase deficiency or relieving symptoms by lactase free diet, alarm signs such as involuntarily weight loss more than 4.5 kg in the last three months, blood detection in the stool or melena or hemoptysis in the last three months, gastrointestinal surgery other than appendectomy, Hernioplasty, inguinal, abdominal wall surgery, cesarean section, hysterectomy and tubal ligation, masticatory disorders, cancer, drugs affecting the movement of the digestive tract such as surfactants, antispasmodic, osmotic laxatives, bulking agents, dopamine antagonists, muscarinic antagonist, 5HT4 and 5HT1 and 5HT3 agonists, antibiotics, opioids, anti-diarrheal medication, symbiotics, antimitotics (eg colchicine), anticholinergics, narcotics, antidepressants, anticonvulsants and any antiflatulance herbal medication two weeks before and during the study, taking antibiotics one month before starting the study, drug or alcohol abuse, lactating and pregnant women.
Age
From 18 years old to 49 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In a double-blind, placebo-controlled clinical trial, neither the patients nor the researchers know who is getting a placebo and who is getting the treatment.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No.9, Pirnya Alley, Lalezar St., Jomhoori St.
City
Tehran
Postal code
Approval date
2013-02-03, 1391/11/15
Ethics committee reference number
1056/ط/م/26-پ

Health conditions studied

1

Description of health condition studied
bloating
ICD-10 code
K31
ICD-10 code description
Diseases of oesophagus,stomach and duodenum

Primary outcomes

1

Description
bloating, abdominal pain, flatulence, eructation, borborygmi, gas incontinence
Timepoint
before intervention, one month after starting the trial,one month after the end of trial
Method of measurement
Likert scale

Secondary outcomes

1

Description
side effects
Timepoint
one month after starting the trial
Method of measurement
questionnaire

Intervention groups

1

Description
Control group:Our placebo is corn starch oral capsules which should be taken three times daily,one capsule after every meal for a month
Category
Placebo

2

Description
Intervention group:Our drug is carum capticum seed oral capsules which should be taken three times daily,one capsule after every meal for a month
Category
Treatment - Drugs

3

Description
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Holy Prophet (PBUH) Hospital
Full name of responsible person
ِDoctor Shahram Agah
Street address
Nyayesh St., Sattarkhan St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Doctor Masoud Younesian
Street address
6th Floor, Central building of Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
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 Tehran University of Medical Sciences
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
Vice chancellor for research of Traditional Medicine Faculty of Tehran University of Medical Science
Full name of responsible person
Maryam Yazdian
Position
Resident
Other areas of specialty/work
Street address
South side of City Park, Behesht St., Vahdate Eslami St.
City
Tehran
Postal code
Phone
+98 21 5569 3520
Fax
Email
ma_yazdian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Traditional Medicine Faculty of Tehran University of Medical Sciences
Full name of responsible person
Doctor Bagher Minaye
Position
Assistant Professor
Other areas of specialty/work
Street address
South side of City Park, Behesht St., Vahdate Eslami St.
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
minaezb@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Traditional Medicine ّFaculty of Tehran University of Medical Sciences
Full name of responsible person
Maryam Yazdian
Position
Traditional Medicine Resident
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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