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IRCT20200112046087N7 IRCT 2021-09-28 Shahid Beheshti University of Medical Sciences Evaluation of the effect of portulaca oleracea syrup on hot flashes Evaluation of the effect of aerial organs portulaca oleracea syrup on menopausal hot flashes 2021-10-23 anticipated 84 Complete https://irct.ir/trial/57355 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups Random description: In this study, we will use the block randomization method and in this two-group clinical trial, we will have 4 blocks of volume. For each person who enters the study, a code is obtained from the software and it is determined which group it belongs to (intervention or control). The tool is Random allocation software, which in addition to simple randomization is able to generate random sequences by blocking. To hide, we use Allocation concealment. This method is such that before assigning the individual, the assigned group is not clear by using opaque envelopes sealed with a random sequence, in which each of the random sequences created on It is registered on a card, and the cards are placed in the envelopes of the letter in order. In order to maintain a random sequence, the numbering on the outer surface of the envelopes is done in the same way. Finally, the lids of the envelopes are glued and placed in a box, respectively . Blocking and preparation of envelopes are done by a person not involved in sampling and analyzing the data. In this way, the collector and the analyst, and the participant do not know the type of intervention received and what group each person is in, Blinding description: In this plan, the drug and placebo are prepared by the pharmacist. After preparing the drug, the pharmacist will insert a specific code of the medicine on the bottle. These codes are available to the pharmacist. The shape and size of all drugs are the same and indistinguishable. Therefore, the project implementer uses the drugs randomly for each patient. At the end of the study, after collecting the data, with the help of a pharmacist, the codes related to the drug and the drug facade are distinguished from each other, but information about the drug and placebo is hidden for the analyzer. Only at the end of the study, The codes are decrypted and the necessary information is provided to the executor. 3 Hot flashes. Intervention 1: Intervention group:Portulaca oleracea syrup formulated in Shahid Beheshti School of Traditional Medicine consumes 3 tablespoons equivalent to 10 cc daily in 3 meals in the morning, noon, and night for one month. To prepare portulaca oleracea syrup, the aqueous extract of the portulaca oleracea plant, which has been prepared by boiling, is used. In the formulation of portulaca oleracea, 25% sugar and 0.25% carboxymethylcellulose (CMC) are used as thickeners. In addition, microbial preservatives including sodium benzoate and potassium citrate (each with a concentration of 0.1%) are used to make the syrup. Intervention 2: Control group: placebo syrup, which is similar in color, shape and size to portulaca oleracea, is given to the patient 3 tablespoons equivalent to 10 cc of syrup daily for 3 months in 3 meals of the morning, noon and night. Formulation of placebo syrup using carboxymethyl Cellulose (CMC) is prepared as a thickener (0.25%) and sugar (25%) along with caramel food coloring, in a water base. Microbial preservatives including sodium benzoate and potassium citrate (each with a concentration of 0.1%) are used to make placebo syrup. Yes - There is a plan to make this available What will be shared: The questionnaires and the information about the main outcome will be shared with the applicants 3 months after the publication of the results. When: After publishing results To whom: researchers Conditions: After the publication of the article , for systematic review studies or meta-analysis Where to obtain: Dr. Mojgan Tansaz Email: tansaz_mojgan@yahoo.com Phone: 02188773525 How to obtain: Sending a request to the main executor of the project, Dr. Mojgan Tansaz, and reviewing the request by her Comments:
public Hanieh Babaei
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences, No. 8, Shams Alley, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 haniehbabaei92@gmail.com Shahid Beheshti University of Medical Sciences scientific Hanieh Babaei
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences, No. 8, Shams Alley, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 haniehbabaei92@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Menopausal women over 45 years Stop menstruation for 12 months or more or less than 12 months with follicle-stimulating hormone Having hot flashes at least twice a day Serum FSH more than 40 international units according to laboratory reports Serum LH more than 30 international units according to laboratory reports 45 years no limit Female Known physical and mental illnesses such as depression, diabetes, cardiovascular disease, hypertension, hyperlipidemia, liver disease, blood diseases, cancer, gastrointestinal diseases Use of hormone therapy, anticoagulants, sedatives, antidepressants, anticonvulsants, alpha-adrenergic agonists such as clonidine Use plant phytoestrogens such as fennel, soy, black cohosh, flax, primrose oil and vitamin E over the past 8 weeks N95.1 Menopausal and female climacteric states Treatment - Drugs Placebo Intervention group:Portulaca oleracea syrup formulated in Shahid Beheshti School of Traditional Medicine consumes 3 tablespoons equivalent to 10 cc daily in 3 meals in the morning, noon, and night for one month. To prepare portulaca oleracea syrup, the aqueous extract of the portulaca oleracea plant, which has been prepared by boiling, is used. In the formulation of portulaca oleracea, 25% sugar and 0.25% carboxymethylcellulose (CMC) are used as thickeners. In addition, microbial preservatives including sodium benzoate and potassium citrate (each with a concentration of 0.1%) are used to make the syrup. Control group: placebo syrup, which is similar in color, shape and size to portulaca oleracea, is given to the patient 3 tablespoons equivalent to 10 cc of syrup daily for 3 months in 3 meals of the morning, noon and night. Formulation of placebo syrup using carboxymethyl Cellulose (CMC) is prepared as a thickener (0.25%) and sugar (25%) along with caramel food coloring, in a water base. Microbial preservatives including sodium benzoate and potassium citrate (each with a concentration of 0.1%) are used to make placebo syrup. Intensity of hot flashes. Timepoint: 2-week monitoring on a daily basis. Method of measurement: Heater et al Scale Questionnaire. Duration of hot flashes. Timepoint: 2-week monitoring on a daily basis. Method of measurement: Heater et al Scale Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2021-06-13 Ethics committee of Shahid beheshti University of Medical Sciences Shahid Chamran Highway - Yemen St. - Shahid Abbas Aarabi St. (Parvaneh) - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Health Services - Tehran Tehran Iran (Islamic Republic of)