Evaluation of the effect of the traditional poly-herbal preparation, “Ghors-e-Vard”, on clinical symptoms of patients with functional dyspepsia with placebo
Design
This study is a randomized, double-blind, placebo-controlled clinical trial with randomized allocation in 4 blocks. Sample size 70, and trial phase is 3
Settings and conduct
Patients referred to Ayatollah Rohani Hospital, Babol University of Medical Sciences' Traditional Medicine and Hope Clinic, divided into intervention and control (35 in each). Gastrointestinal symptom severity (GSRS questionnaire score) will be assessed at baseline, and weeks 2, 4 and 8. Drug/placebo are coded randomly in identical packages. Patients, principal investigators are unaware of packages.
Participants/Inclusion and exclusion criteria
Inclusion: People aged 18-60 years, with functional dyspepsia (based on ROME IV syndrome)
Exclusion: history of gastrointestinal ulcer or reflux disease with natural endoscopy without specific pathologic findings, underlying diseases including heart failure, hypertension, renal failure and uremic disease, cirrhosis; history of abdominal surgery; any malignancy or individuals NSAIDs are used, having a history of chemotherapy and radiotherapy or exposure to radiation. Use of any other herbal medicine; pregnancy and lactation; positive urea breath test for Helicobacter pylori infection
Intervention groups
Intervention group: To evaluate the therapeutic effect of Ghors-Vard on clinical symptoms of dyspepsia, patients will receive capsules containing Ghors-Vard three times daily (after meals) for 1 month.
Control group: In order to compare the effect of the Ghors-Vard with the placebo effect on the clinical symptoms of functional dyspepsia, patients in the control group take placebo capsules three times daily (after meals) for 1 month.
Main outcome variables
Clinical symptoms of patients with functional dyspepsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200128046291N1
Registration date:2020-03-09, 1398/12/19
Registration timing:prospective
Last update:2020-03-09, 1398/12/19
Update count:1
Registration date
2020-03-09, 1398/12/19
Registrant information
Name
Hossein kerdarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4274 0373
Email address
hosseinkerdarian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the traditional poly-herbal preparation, “Ghors-e-Vard”, on clinical symptoms of patients with functional dyspepsia
Public title
The effect of the “Ghors-e-Vard” on functional dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Functional dyspepsia
Ages 18 to 65 years
Exclusion criteria:
History of gastrointestinal ulcer or reflux disease with natural endoscopy with no specific pathologic findings,
Underlying diseases including heart failure, hypertension, renal failure and uremic disease, cirrhosis
History of abdominal surgery
Any malignancy
NSAIDs Use
Having a history of chemotherapy and radiotherapy or exposure to radioactive radiation.
Use of any other herbal medicine
Pregnancy and lactation
Positive urea breath test for Helicobacter pylori infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by permuted block randomization. And medicines will be randomly allocated to patients in blocks with size four. Blinding will be double-blinded in the study. Patients will not be aware of their placement in the two groups and medications will be provided in identical forms for both groups. The researcher responsible for collecting baseline information and outcomes will also not be aware of the type of medication the patient is taking.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug and placebo are both prepared in identical non-transparent capsules and in completely similar cans and packages and coded according to the random table. None of the participants, principal investigator, health care personnel (physicians, nurses, etc.) responsible for patient care (etc.), data collectors and statistical analysts, will not be aware of patient received package and the coding.
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 Sciences
Street address
Ghasemi.st
City
babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2020-01-22, 1398/11/02
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.319
Health conditions studied
1
Description of health condition studied
Functional dyspepsia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in clinical symptoms of functional dyspepcia
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)
Secondary outcomes
1
Description
Epigastric pain
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)
2
Description
Heart burn
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)
3
Description
Early satiety
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)
4
Description
Feeling fullness after meals
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)
5
Description
Nausea
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)
6
Description
Burp
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale (GSRS)
7
Description
Flatulence
Timepoint
In days 0,14,30,60
Method of measurement
Gastrointestinal Symptom Rating Scale(GSRS)
8
Description
Quality of Life
Timepoint
In days 0,30
Method of measurement
Quality of Life Questionnaire (SF36)
Intervention groups
1
Description
Intervention group: 35 patients with functional dyspepsia take 30 capsules of "Ghorse- vard" 3 times a day for 30 days after a meal. For small-lab-scale preparation of Ghors-Vard, in the clean room of the Traditional Pharmacy Lab of the Faculty of Traditional Medicine of Babol, under laboratory conditions, each of the dried herbs are individually milled, powdered and passed through 60 mesh sieve. Then, according to traditional medicine sources, the required weight ratio of the powders is carefully mixed together and poured into mortar. The powder is then briefly moistened and granulated and then passed through a 40 mesh sieve. After drying and disinfecting the resulting granule in microwave in three 1 minute steps, the granules are re-milled and passed through sieve 60. After microbial control tests and quantification of phenolic compounds, the powder is filled by a capsule filler in 500 mg capsules.
Category
Treatment - Other
2
Description
Control group: 35 patients with functional dyspepsia take 30 capsules of placebo 3 times a day for 30 days after a meal. For placebo preparation, in the clean room of the Traditional Pharmacy Lab of Babol Faculty of Traditional Medicine, under laboratory conditions, corn starch is disinfected by microwave in three minute steps, then is mixed with 1% of the Ghors-Vard powder mixed until the smell is a bit similar to the Ghors-Vard product. After microbial control tests, the powder is filled by a a manual capsule filling machine in 500 mg capsules.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Hosseinkerdarian
Street address
Ganj Afrooz st.
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 1222 9591
Fax
+98 11 1229 0181
Email
rohani@mubabol.ac.ir
2
Recruitment center
Name of recruitment center
Hope Clinic of Babol University of Medical Sciences
Full name of responsible person
Hosseinkerdarian
Street address
Ganj Afrooz st.
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3220 7751
Email
rohani@mubabol.ac.ir
3
Recruitment center
Name of recruitment center
Health clinic of Iranian medicine of Babol University of Medical Sciences
Full name of responsible person
Hosseinkerdarian
Street address
Ghasemi st.
City
Babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3225 3526
Email
timbabol@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Ghasemi st.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hossein Kerdarian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 47745-47176, Ghasemi st.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
Hosseinkerdarian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Zahra Memariani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacy in traditional medicine
Street address
No. 47745-47176 , Ghasemi st.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
z.memariani@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hossein Kerdarian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 47745-47176 , Ghasemi st.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
Hosseinkerdarian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be included in the thesis after being unrecognizable
When the data will become available and for how long
After completing the examinations, it will be fully inserted into the thesis
To whom data/document is available
All researchers will have access to the central library of Babol University of Medical Sciences
Under which criteria data/document could be used
Once inserted in the thesis it will be applicable
From where data/document is obtainable
Refer to the library of Babol University of Medical Sciences and after providing information
What processes are involved for a request to access data/document
Refer to the library of Babol University of Medical Sciences and after providing information