comparison the effect of hydro alcoholic extract of Nardostachys jatamansi DC with the effect of hydro alcoholic extract of Nardostachys jatamansi DC with Dompridon® on the symptoms of patients with functional dyspepsia® on the symptoms of patients with functional dyspepsia/post postprandial distress syndrome.
This Double-Blind, Phase 0 trial ,will be done to compare the effect of Nardostachys jatamansi DC with Dompridon® on decreasing the severity of symptoms in patients with functional dyspepsia.A total number of 128 ,25 to 60 years-old patients with functional dyspepsia according to Roman criteria 3 that selected by a specialist physician from the referred patients to the Liver and Gastrointestinal Diseases Clinic , entered into the study after obtaining informed consent. patient with a history of use any chemical or herbal drug with the gastrointestinal effects and pregnant women will be excluded. patients All patients will randomly divided into two groups with use of a table of random digits. In the intervention group patients will receive hydro-alcoholic extract powder of Nardostachys jatamansi DC capsules ,500 milligrams, three times in a day half-hour before each meal .In the control group Domperidone capsule of Abidi company (Motidon), 10 milligrams ,three times in a day half-hour before each meal will prescribe.Capsules are completely compatible in two groups and patients are not aware of the type of medication. Duration of treatment was 4 weeks in both groups and the Gastrointestinal symptoms rating scale questioner was completed before, 2nd and 4th weeks of treatment as well as one month after the end of the treatment. All primary data and outcomes are collected and recorded by the Assistant of Traditional Medicine using In-person and telephone interviews.
Analysis of the information during the study and, finally, by the statistics consultant and without the knowledge of the type of allocation of drugs to the two groups will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022332738N1
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Mohaddese Mirzapour
Name of organization / entity
Babol University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 3576
Email address
m.mirzapor@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Babol University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effect of hydro alcoholic extract of Nardostachys jatamansi DC with the effect of hydro alcoholic extract of Nardostachys jatamansi DC with Dompridon® on the symptoms of patients with functional dyspepsia® on the symptoms of patients with functional dyspepsia/post postprandial distress syndrome.
Public title
Effect of Nardostachys jatamansi DC on clinical symptoms of functional dyspepcia /postprandial distress syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 25 to 60 years; with a diagnosis of functional dyspepsia (based on ROME IIIcriteria ) and no history of peptic ulcer and reflux disease; normal endoscopic with no specific pathologic finding and H. pylori negative; no treatment before the current study(new patient); there is no underlying medical conditions; including heart failure; kidney failure and uremic disease; cirrhosis; diabetes; hypothyroidism and hyperthyroidism; no history of abdominal surgery; no history of chemotherapy and radiation or exposure radioactive radiation.
Exclusion criteria: use of chemical and herbal drugs with gastrointestinal effects; pregnancy and lactation; patients disagreement to continue the project and lack of access to patients
Age
From 25 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not 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 Sciences
Street address
Daneshgah sq.,Ganjafroz st., Keshvari St.
City
Babol
Postal code
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
MUBABOL.REC.1395.200
Health conditions studied
1
Description of health condition studied
functional dyspepcia
ICD-10 code
K30
ICD-10 code description
Dyspepsia
Primary outcomes
1
Description
total score of gastrointestinal symptom rating scale
Timepoint
before intervention , the scond and forth weeks of the intervention,one month after the end of intervention
Method of measurement
Gastrointestinal symptom rating scale
Secondary outcomes
1
Description
drug complication
Timepoint
intervention period and after tretment
Method of measurement
questioner
Intervention groups
1
Description
Intervention grope:Nardostachys jatamansi DC capsuls, 400 mgr after each meal(TDS)T for one month.
Category
Treatment - Drugs
2
Description
control grope:Domperidone capsules,10 mgr after each meal(TDS)T for one month.