Protocol summary

Summary
Objective: comparison of efficacy of Mentha pulegium L. with that of placebo in treatment of patients with functional dyspepsia. Study design: randomized, double-blind, placebo-controlled, two group parallel design, single-center, phase 2 of clinical trial. Study population: patients with functional dyspepsia attending Baqiyatallah Hospital (Tehran, Iran). Inclusion criteria: patients aged 20 to 80; patients with functional dyspepsia according to the ROME III criteria; patients in whom upper gastrointestinal endoscopy has not shown any organic causes of dyspepsia; patients without organic, systemic and metabolic diseases causing dyspepsia. Exclusion criteria: patients with peptic ulcer disease, inflammatory bowel disease, irritable bowel syndrome, pure gastro-esophageal reflux disease and any organic gastrointestinal disease; patients with a history of Helicobacter pylori infection eradicating drugs use within the past 3 months; patients with a history of gastrointestinal system surgery; patients with background systemic diseases such as diabetes mellitus, heart failure, hepatic failure, renal failure, asthma, chronic obstructive pulmonary disease, neoplasms and severe psychiatric diseases; patients addicted to alcohol and opium; patients using cardiac, antihypertensive, antipsychotic, antianxiety, antibiotic and corticosteroid drugs and iron and calcium; patients with a history of discontinuing prescribed pharmacotherapy and incomplete treatment; pregnant women; women planning pregnancy; breast-feeding women. Sample size: 100 patients. Interventions: pennyroyal leaf extract is administered to a group of about 50 patients at the dose of one 330 mg capsule every 8 hours for 2 months and placebo capsule is administered to another parallel group of about 50 patients every 8 hours for 2 months. Before intervention and 2 months after intervention, the primary and secondary outcome variables are evaluated. Primary outcome variable: dyspepsia. Secondary outcome variables: Helicobacter pylori infection, quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201602172288N9
Registration date: 2016-04-08, 1395/01/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Saeed Kianbakht
Name of organization / entity
Iranian Academic Center for Education, Culture and Research Institute of Medicinal Plants
Country
Iran (Islamic Republic of)
Phone
+98 26147640109
Email address
kianbakht@imp.ac.ir
Recruitment status
Recruitment complete
Funding source
ACECR Institute of Medicinal Plants
Expected recruitment start date
2015-12-21, 1394/09/30
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Mentha pulegium L. with that of placebo in treatment of patients with functional dyspepsia
Public title
Effects of pennyroyal in treatment of functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20 to 80; patients with functional dyspepsia according to the ROME III criteria; patients in whom upper gastrointestinal endoscopy has not shown any organic causes of dyspepsia; patients without organic, systemic and metabolic diseases causing dyspepsia. Exclusion criteria: patients with peptic ulcer disease, inflammatory bowel disease, irritable bowel syndrome, pure gastro-esophageal reflux disease and any organic gastrointestinal disease; patients with a history of Helicobacter pylori infection eradicating drugs use within the past 3 months; patients with a history of gastrointestinal system surgery; patients with background systemic diseases such as diabetes mellitus, heart failure, hepatic failure, renal failure, asthma, chronic obstructive pulmonary disease, neoplasms and severe psychiatric diseases; patients addicted to alcohol and opium; patients using cardiac, antihypertensive, antipsychotic, antianxiety, antibiotic and corticosteroid drugs and iron and calcium; patients with a history of discontinuing prescribed pharmacotherapy and incomplete treatment; pregnant women; women planning pregnancy; breast-feeding women.
Age
From 20 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block randomization with computer generated random numbers table and sequentially numbered containers each representing a block consisting of two patients are used for the treatment assignments.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Molla Sadra street, Vanak square
City
Tehran
Postal code
1435915371
Approval date
2015-12-20, 1394/09/29
Ethics committee reference number
IR.BMSU.REC.1394.149

Health conditions studied

1

Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Dyspepsia

Primary outcomes

1

Description
Dyspepsia
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Hong Kong dyspepsia index questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
Before intervention and 2 months after intervention
Method of measurement
SF-36 questionnaire

2

Description
Helicobacter pylori infection
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Urease test

3

Description
Adverse drug reactions
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Patient questioning

Intervention groups

1

Description
Pennyroyal leaf extract is administered to a group of about 50 patients at the dose of one 330 mg capsule every 8 hours for 2 month.
Category
Treatment - Drugs

2

Description
one placebo capsule is administered to another group of about 50 patients every 8 hours for 2 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Dr. Reza Mohtashami
Street address
Molla Sadra street, Vanak square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Reza Hajiaghaee
Street address
ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Grant name
1892
Grant code / Reference number
1892
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of ACECR Institute of Medicinal Plants
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
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
Institute of Medicinal Plants, ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Postal code
Phone
+98 26 3476 4010
Fax
Email
skianbakht@yahoo.com; kianbakht@imp.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Postal code
Phone
+98 26 3476 4010
Fax
Email
skianbakht@yahoo.com; kianbakht@imp.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
ACECR Institute of Medicinal Plants
Full name of responsible person
Dr. Saeed Kianbakht
Position
Ph.D. in pharmacology, assistant professor of the department of pharmacology and applied medicine in
Other areas of specialty/work
Street address
ACECR Complex, Supa Boulevard, Poleh Kordan
City
Karaj
Postal code
2378965473
Phone
+98 264734010
Fax
+98 26 3476 4021
Email
skianbakht@yahoo.com; kianbakht@imp.ac.ir
Web page address
www.imp.ac.ir

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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