Study of effect herbal product Asang (myrtus+ plantago) and Persian Medicine dietary modification with Tranexamic acid on menorrhagia :A randomized controlled trial
Comparison of the effect of Iranian medicine product (case and barhang) and dietary measures with tranexamic acid in menorrhagia: a randomized controlled clinical trial.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients, simple block randomization is used for randomization.
Settings and conduct
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 tranexamic 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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Group A: receiving 2 capsules of tranexamic acid 250 mg after each meal
Group B: receiving 2 Ashang 250 mg capsules after each meal
Group C: receiving 2 capsules of tranexamic acid 250 mg after each meal and dietary measures for menorrhagia of Iranian medicine
Group D: receiving 2 capsules of Ashang 250 mg after each meal and nutritional measures for menorrhagia of Iranian medicine
Main outcome variables
Higham Score Questionnaire (PBAC,Pictorial Blood loss Assessment Chart)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221212056789N1
Registration date:2023-03-12, 1401/12/21
Registration timing:prospective
Last update:2023-03-12, 1401/12/21
Update count:1
Registration date
2023-03-12, 1401/12/21
Registrant information
Name
sabikeh salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 7189
Email address
sabikehsalehi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-27, 1402/02/07
Expected recruitment end date
2023-09-29, 1402/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect herbal product Asang (myrtus+ plantago) and Persian Medicine dietary modification with Tranexamic acid on menorrhagia :A randomized controlled trial
Public title
Effect Asang and Persian Medicine dietary modification with Tranexamic acid on menorrhagia
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block
Blinding (investigator's opinion)
Double blinded
Blinding description
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 2 capsules of tranexamic acid 250 mg after each meal
Group B: receiving 2 Ashang 250 mg capsules after each meal
Group C: receiving 2 capsules of 250 mg tranexamic acid and dietary measures for menorrhagia of Iranian medicine
Group D: receiving 2 Ashang 250 mg capsules and nutritional measures for menorrhagia in Iranian medicine
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Excessive and frequent menstruation with regular cycle
ICD-10 code
N92.0
ICD-10 code description
Excessive and frequent menstruation with regular cycle
Primary outcomes
1
Description
Primary outcome: Higham questionnaire score (PBAC)(Pictorial Blood loss Assessment Chart)
Timepoint
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
Method of measurement
Higham Questionnaire (PBAC)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: receiving 2 capsules of 250 mg tranexamic acid after each meal
Category
Treatment - Drugs
2
Description
Intervention group2: Take 2 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)
Category
Treatment - Drugs
3
Description
Intervention group3: Received 2 capsules of tranexamic 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)
Category
Treatment - Drugs
4
Description
Intervention group4: Received 2 Ashang 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)
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome will be shared after de-identification of individuals
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
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.
Under which criteria data/document could be used
If researchers, doctors and people working in the pharmaceutical industry want to use Ashang medicine, documents will be given to them.
What processes are involved for a request to access data/document
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