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IRCT20150819023684N5 IRCT 2018-04-17 Iran University of Medical Sciences Evaluation of the Effect of Lactobacilli on Pain Relief in Endometriosis Evaluation of the Effect of Administration of Lactobacilli on Pain Relief in Endometriosis 2016-11-21 anticipated 30 Complete https://irct.ir/trial/20198 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple random method was used for Randomization with using random numbers table. for allocations concealment, individuals outside the study were used for random allocation, Blinding description: This study is designed triple -blind, so that the researcher, subject and statistical analyst are not aware of the status of the allocation of the two groups. Because the administration of the drug and placebo happens under the exactly same appearance, therefore, the subject is not aware of the assignment of the groups. The researcher measuring clinical and diagnostic measures is not aware of the status of the individual, and the statistician is also unaware of the allocation of people to study groups. Only the observer is aware of the allocation of the groups. 3 Endometriosis. Intervention 1: Intervention Group: Lactobacilli tablets, once daily with the trade name "Lactofem" from Zist Takhmir Pharmaceutical Company which contains 10 to the power 9 colony count of the following lactobacilli: Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus fermentum, Lactobacillus gasseri. The tablet will be taken for 8 weeks and the patient will be evaluated after 8 and 12 weeks after the beginning of the treatment. Intervention 2: Control group: Placebo treatment; daily 1 tablet of the placebo which is made by the pharmaceutical company Zist Takhmir with the exactly same packaging and appearance with "Lactofem". The tablet will be taken for 8 weeks and the patient will be evaluated after 8 and 12 weeks after the beginning of the treatment. Yes - There is a plan to make this available What will be shared: All data except personal information When: After publication of Paper To whom: Researchers working in research and academic centers Conditions: further research Where to obtain: Dr. Khodaverdi How to obtain: Request via email Comments:
public Dr. Sepideh Khodaverdi
Rasool Akram Hospital. Niayesh St. Sattarkhan Street. Rasool Akram Hospital, Department of Obstetrics and Gynecology, Endometriosis Research Center.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2562 sepidehkhodaverdi@yahoo.com Iran University of Medical Sciences scientific Dr. Sepideh Khodaverdi
Rasool Akram Hospital, Niayesh Avenue, Sattarkhan Street.
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2562 sepidehkhodaverdi@yahoo.com Iran university of medical science Iran (Islamic Republic of) Definitive diagnosis of endometriosis Menstrual cycle in the range of 21-35 days Aged 18-45 years Those who had VAS (Visual Analogue Scale) Score intensity of 5 or more for their pain intensity Passing at least 3 months and 1 year at the most since surgery 18 years 45 years Female Patients who had received hormonal treatment during the past 3 months History of liver or renal disease history of carcinoma Patients with history of diarrhea after consuming dairy products Consumption of food or any type of probiotic product Those who had a pain intensity of less than 5 according to the VAS Score Patients who had received antibiotics during the past 3 months N80 Endometriosis Treatment - Drugs Treatment - Drugs Intervention Group: Lactobacilli tablets, once daily with the trade name "Lactofem" from Zist Takhmir Pharmaceutical Company which contains 10 to the power 9 colony count of the following lactobacilli: Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus fermentum, Lactobacillus gasseri. The tablet will be taken for 8 weeks and the patient will be evaluated after 8 and 12 weeks after the beginning of the treatment. Control group: Placebo treatment; daily 1 tablet of the placebo which is made by the pharmaceutical company Zist Takhmir with the exactly same packaging and appearance with "Lactofem". The tablet will be taken for 8 weeks and the patient will be evaluated after 8 and 12 weeks after the beginning of the treatment. Mean VAS score. Timepoint: 8 and 12 weeks after starting of drug use. Method of measurement: VAS Questionnaire. Drug Adverse Effects. Timepoint: 8 and 12 Weeks after starting drug use. Method of measurement: Questionnaire. Iran University of Medical Sciences Approved 2016-12-04 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)