Protocol summary
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Study aim
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Evaluation of the effect of Perforate St John's-wort , Matricaria chamomilla , Citrus aurantium , Portulaca oleracea in patients with gastric ulcers.
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Design
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A clinical trial with a control group, with parallel groups, double-blind, randomized
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Settings and conduct
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Endoscopic gastric ulceration is confirmed in both groups. Patients in group 1 were asked to take a herbal capsule one hour before each meal with their standard drug. Patients are asked to continue their usual diet during the study. Patients will be visited at the end of the eighth week and re-examined by endoscopy in addition to a clinical examination. This study is double blind and will be done in hospitals of Islamic Azad universty,mashhad branch.
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Participants/Inclusion and exclusion criteria
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Gastric ulcer, willingness to participate in the study/
taking antidepressants agents (SSRI) , pregnancy, breastfeeding,history of alchohol consumption
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Intervention groups
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The intervention group consist of people who, receive the 600 mg herbal capsules which is made by pharmacist, one hour before each meal in addition to their standard medication for eight weeks. These capsules contain 150 mg of Perforate St John's-wort, 150 mg of Matricaria chamomilla , 150 mg of Citrus aurantium and 150 mg of Portulaca oleracea. Patients will be re-examined at the end of the 8th week by clinical and endoscopic examination. The control group also includes patients receiving starch capsules (placebo), in addition to their standard medication.
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Main outcome variables
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Gastric ulcer size on endoscopy. Epigastric pain and burning on clinical examination and visual analog scale (VAS)
General information
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Reason for update
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making a minor change in the title,so that it can show a more specific concept of the research
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151230025772N10
Registration date:
2022-12-11, 1401/09/20
Registration timing:
prospective
Last update:
2023-06-26, 1402/04/05
Update count:
1
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Registration date
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2022-12-11, 1401/09/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-22, 1401/10/01
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Expected recruitment end date
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2023-06-21, 1402/03/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of herbal supplement capsule on treatment of peptic disease patients
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Public title
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Evaluating the effect of herbal supplement capsule on treatment of peptic disease patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Gastric ulcer or erosion, confirmed by endoscopy
Exclusion criteria:
Taking antidepressants agents (SSRI)
History of alcohol consumption
Breastfeeding and pregnancy
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Age
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No age limit
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization. Sealed envelopes are used to hide the treatment. Random numbers between 0 and 1 will be generated using the calculator. Envelopes that receive codes between 0 and 0.5 will be filled with placebo and envelopes that receive codes between 0.5 and 1 will be filled with medicine. In this way, the envelopes are arranged in a random order. The envelopes are thick and opaque. Patients and physicians do not know the content of the codes until the end of the study.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this double-blind study, sealed envelopes are used to hide the treatment from the physician and patients. Physician and patients are unaware of the contents of the drug or placebo envelopes. Herbal medicines and placebo are being placed inside similar capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-08-29, 1401/06/07
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Ethics committee reference number
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IR.IAU.MSHD.REC.1401.086
Health conditions studied
1
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Description of health condition studied
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Gastric ulcer
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ICD-10 code
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K25
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ICD-10 code description
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Gastric ulcer
Primary outcomes
1
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Description
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Gastric ulcer size
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Timepoint
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before intervention/8 weeks after intervention
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Method of measurement
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endoscopy
2
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Description
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Epigastic discomfort
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Timepoint
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before intervention/8 weeks after intervention
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Method of measurement
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Visual Analogue Scale
3
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Description
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Helicobactepylori infection
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Timepoint
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before intervention/8 weeks after intervention
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Method of measurement
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endoscopy
Intervention groups
1
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Description
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Intervention group: patients receive herbal capsules which are made by pharmacist, up to 8 weeks along with their standard medication one hour before each meal. The weight of each capsule will be 600 mg and its contents will include 150 mg of Perforate St John's-wort, 150 mg of Portulaca oleracea, 150 g of Matricaria chamomilla and 150 mg of Citrus aurantium
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zojaj Darman Toos pharmaceutical company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available