Protocol summary
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Study aim
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Comparison of the effect of Iranian medicine product (case and barhang) and dietary measures with mefenamic acid in menorrhagia: a randomized controlled clinical trial.
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Design
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Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients, simple block randomization is used for randomization.
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Settings and conduct
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This clinical trial is a double-blind randomized trial and is conducted on qualified women at the Women's Clinic of Sayad Shirazi Educational-Therapeutic Center, Gorgan. are classified, the capsule of tranexamic acid is prepared from the pharmaceutical market and the Ashang capsule is produced with an appearance completely similar to the capsule of mefenamic acid and it is provided to the research samples based on random codes. In this study, the researcher and the subjects Reading will not know the contents of the packages.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Unmarried women 18-50 years old, regular menstrual cycle, suffering from menorrhagia based on PBAC (Pictorial Blood loss Assessment Chart) criteria, patient satisfaction, hemoglobin more than 10
Non-entry criteria: Severe uterine bleeding that requires surgical intervention, pregnancy and breastfeeding
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Intervention groups
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Group A: receiving 1capsules of mefenamic acid 250 mg after each meal
Group B: receiving 1 Ashang 250 mg capsules after each meal
Group C: receiving 1 capsules of mefenamic acid 250 mg after each meal and dietary measures for menorrhagia of Iranian medicine
Group D: receiving1 capsules of Ashang 250 mg after each meal and nutritional measures for menorrhagia of Iranian medicine
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Main outcome variables
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Higham Score Questionnaire (PBAC,Pictorial Blood loss Assessment Chart)
General information
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Reason for update
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Changing the chemical drug of the research plan
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221212056789N1
Registration date:
2023-03-12, 1401/12/21
Registration timing:
prospective
Last update:
2024-04-14, 1403/01/26
Update count:
1
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Registration date
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2023-03-12, 1401/12/21
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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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2024-04-26, 1403/02/07
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Expected recruitment end date
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2024-09-28, 1403/07/07
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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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Study of effect herbal product Ashang (myrtus+ plantago) and Persian Medicine dietary modification with Mefenamic acid on menorrhagia :A randomized controlled trial
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Public title
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Effect Ashang and Persian Medicine dietary modification with Mefenamic acid on menorrhagia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Unmarried women, 18-50 years old
Regular menstrual cycle
Suffering from menorrhagia based on PBAC criteria
Patient satisfaction
Hemoglobin more than 10
Exclusion criteria:
Severe uterine bleeding that requires surgical interventions
Pregnancy or breastfeeding
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
120
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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, block
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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We will prepare a number of 120 envelopes with the numbers 1 to 120 written on them, and the contents of the envelopes will be determined based on the order of the letters A, B, C, D in each of the removed blocks, so that only one letter is placed in each envelope. He delivers them to the patients and does not know what is inside. Therefore, in addition to the patient, the drug prescriber also does not know how to allocate patients. According to the letter inside the envelope, the patients are placed in the desired group according to the following division.
Group A: receiving 1 capsules of mefenamic acid 250 mg after each meal
Group B: receiving 1 Ashang 250 mg capsules after each meal
Group C: receiving 1 capsules of 250 mg mefenamic acid and dietary measures for menorrhagia of Iranian medicine
Group D: receiving 1 Ashang 250 mg capsules and nutritional measures for menorrhagia in Iranian medicine
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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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2024-03-12, 1402/12/22
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Ethics committee reference number
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IR.GOUMS.REC.1401.413
Health conditions studied
1
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Description of health condition studied
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Excessive and frequent menstruation with regular cycle
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ICD-10 code
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N92.0
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ICD-10 code description
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Excessive and frequent menstruation with regular cycle
Primary outcomes
1
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Description
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Primary outcome: Higham questionnaire score (PBAC)(Pictorial Blood loss Assessment Chart)
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Timepoint
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At the beginning of the study (before the start of the intervention) and at the end of the study period, i.e. after 3 cycles of treatment with Ashang
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Method of measurement
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Higham Questionnaire (PBAC)
Intervention groups
1
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Description
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The first intervention group: receiving 1 capsules of 250 mg mefenamic acid after each meal
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Category
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Treatment - Drugs
2
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Description
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Intervention group2: Take1 Ashang 250 mg capsules after every meal(Ashang capsule consists of fruit extract and bay leaf extract, and after being formulated based on Iranian medicine sources, it is made by the researcher of Niak company)
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Category
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Treatment - Drugs
3
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Description
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Intervention group3: Received1capsules of mefenamic acid 250 mg and dietary remedies for menorrhagia of Iranian medicine(In addition to transamsamic acid capsules, one of the nutritional measures of Iranian medicine, which is designed as a daily diet, is provided to the participants of this group)
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Category
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Treatment - Drugs
4
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Description
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Intervention group4: Received1Ashang 250 mg capsules and nutritional measures of Iranian medicine menorrhagia(In addition to the Ashang capsule, one of the dietary measures of Iranian medicine, which is designed as a daily diet, is provided to the participants of this group)
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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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Gorgan University of Medical Sciences
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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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Public
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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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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Information on the main outcome will be shared after de-identification of individuals
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When the data will become available and for how long
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The access period starts 3 months after the results are published
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To whom data/document is available
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The data will be available to researchers working in academic and scientific institutions, as well as people working in industry can apply to receive them.
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Under which criteria data/document could be used
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If researchers, doctors and people working in the pharmaceutical industry want to use Ashang medicine, documents will be given to them.
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From where data/document is obtainable
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Sabikeh Salehi-0098 9113756964
sabikeh.salehi@gmail.com
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What processes are involved for a request to access data/document
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By sending an e-mail to the given e-mail address and introducing yourself and stating the reason for requesting the documents, after confirming the information sent, the documents will be sent to them
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Comments
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