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IRCT20190625044004N1 IRCT 2021-06-28 Ghoum University of Medical Sciences Comparative study of the effect of chamomile and flaxseed oil on patients with endometriosis Comparative study of the effect of hydroalcoholic extract of chamomile and flaxseed oil on pelvic pain, dyspnea and dysmenorrhea in patients with endometriosis 2019-12-01 anticipated 108 Complete https://irct.ir/trial/40499 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the limited randomization method of block randomization will be used. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to ensure that the number of samples assigned to each of the study groups is equal in cases where intermediate analyzes are required during the sampling process. The size of all the blocks is equal and in this We will have a three-group trial of 36 blocks of 3. Randomization tool also uses random sequence generation software that these random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method. For concealment, random allocation concealment is used, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence in which each of the random sequences created on a card It is registered and the cards are placed in the letter envelopes in order To be. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the sampling, one of the envelopes of the letter is opened and the assigned group of the participant is revealed, based on the order of entry of the eligible participants, Blinding description: Starting the treatment cycle, if the patient chooses code A, medication A is given and either B or C is given (for example A recipient of chamomile capsule and B code for flaxseed oil and C code for placebo). The coding is performed by a pharmacist.) The drugs are quite similar in appearance and are unknown to the researcher and patient, and are only known to the pharmacist but are quite similar in appearance. Each medication is packaged in separate packages coded with the letters A, B, and C and provided to research units. 3 Endometriosis. Intervention 1: Intervention group: Chamomile -Dosage: 9 gr daily Dosage: 2 months- Frequency of use: In three divided doses (3 gr every 8 hours) How to use: Oral capsule - Producer: Pharmacist. Intervention 2: Intervention group: Flaxseed - Dosage: 6 gr daily Dosage: 2 months - Frequency: In three divided doses (2 gr every 8 hours) How to use: Oral capsule - Producer: Pharmacist. Intervention 3: Control Placebo - Dosage: 3 gr daily Dosage: 2 months - Dosage: In three divided doses (1 gr every 8 hours) How to use: Avicel oral capsule - Manufacturer: Pharmacistgroup:. Yes - There is a plan to make this available What will be shared: Individual data related to participants When: Start the access period 6 months after printing the results To whom: It will only be available to researchers working in academic and scientific institutions Conditions: Items that are in line with the studied variables Where to obtain: first name and last name: Fatemeh Mahnazadeh Fallahieh Email: mohana6492@gmail.com How to obtain: After requesting the email, the data will be sent within a week of the applicant's email Comments:
public Fatemeh Mohanazadehflaheieh
Shahid Lavasani St. - Qom University of Medical Sciences and Health Services
Qom Iran (Islamic Republic of) 3713649373 0098 2531071 mohana6492@gmail.com Ghoum University of Medical Sciences scientific Zohreh kalajinia
Shahid Lavasani St. - Qom University of Medical Sciences and Health Services
Qom Iran (Islamic Republic of) 3713649373 0098 253107 zkh6033@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) Married Pelvic pain dysmenorrhea dysparonia Hypovaccular mass and ultrasound vascular with varying degrees of blood flow velocity And the number of vessels seen in Doppler ultrasoundPatients who referred to the Jihad Infertility Center of the University Insensitivity to chamomile and flaxseed 20 years 45 years Female Has underlying heart, kidney, liver disease Taking hormonal drugs such as oral contraceptive pills, progesterones N80.1 Endometriosis of ovary Treatment - Drugs Treatment - Drugs Placebo Intervention group: Chamomile -Dosage: 9 gr daily Dosage: 2 months- Frequency of use: In three divided doses (3 gr every 8 hours) How to use: Oral capsule - Producer: Pharmacist Intervention group: Flaxseed - Dosage: 6 gr daily Dosage: 2 months - Frequency: In three divided doses (2 gr every 8 hours) How to use: Oral capsule - Producer: Pharmacist Control Placebo - Dosage: 3 gr daily Dosage: 2 months - Dosage: In three divided doses (1 gr every 8 hours) How to use: Avicel oral capsule - Manufacturer: Pharmacistgroup: Pain score of people with dysmenorrhea. Timepoint: Measurement of reduction of dysmenorrhea before intervention and one month and two months after intervention After starting Consumption Chamomile and flaxseed oil and placebo. Method of measurement: Using Visual Analogue Scale. Pain score of people with chronic pelvic pain. Timepoint: Measurement of reduction of pelvic pain before intervention and one month and two months after intervention After starting Consumption Chamomile and flaxseed oil and placebo. Method of measurement: Using Visual Analogue Scale. Pain score of people with dysparonia. Timepoint: Measurement of reduction of dysdisparonia before intervention and one month and two months after intervention After starting Consumption Chamomile and flaxseed oil and placebo. Method of measurement: Using Visual Analogue Scale. Ghoum University of Medical Sciences Approved 2019-03-06 Ethics committee of Qom University of Medical Sciences Shahid Lavasani St, Qom University of Medical Sciences Qom Ghoum Iran (Islamic Republic of)