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IRCT20210222050457N2 IRCT 2023-05-08 Yazd University of Medical Sciences Evaluation of the effect of herbal combination of fenugreek seeds and carrot seeds on sexual function 0fwomen with diabetes type 2,a randomized double-blinded clinical trial Evaluation of the effect of herbal combination of fenugreek seeds and carrot seeds on sexual function of women with diabetes type 2,a randomized double-blinded clinical trial 2023-05-31 anticipated 100 Complete https://irct.ir/trial/69481 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: People are randomly divided to drug and placebo groups. The drug group received 500 mg herbal tablets three times a day, and the placebo group received placebo tablets with the same prescription, Blinding description: The intervention group received 500 mg herbal tablets three times a day, and the placebo group received placebo tablets with the same order. N/A Type 2 diabetes with sexual dysfunctionٍ. Intervention 1: The intervention group consumes 500 mg herbal tablets three times a day. The drug is prescribed to patients for 8 weeks by a non-researcher, based on masking. The raw materials of this product, which include carrot seeds and fenugreek seeds, are first subjected to quality control tests, including the amount of waste particles, moisture, total ash, and determining the amount of an indicator substance or total essential oil. After determining the quality of each plant, 250 mg of 5% fenugreek seed extract (Fenugreek seed extract) is mixed with 250 mg of carrot seed powder and then sieved and produced in the form of 500 mg tablets with a press machine. Intervention 2: The control group consumes 500 mg placebo tablets made of starch but with a completely similar appearance to the drug three times a day. The placebo is prescribed to patients for 8 weeks by a non-researcher. Yes - There is a plan to make this available What will be shared: The data will publish in the form of a thesis When: 6 months after the results are published To whom: For researchers working in academic and scientific institutions Conditions: With an official letter from the Research and Technology Vice-Chancellor of Yazd University of Medical Sciences Where to obtain: Fatemeh Shirvanizadeh, Faculty of Persian Medicine, Ardakan, Yazd How to obtain: Refer to the research and technology unit of Yazd University of Medical Sciences and ask for it Comments:
public Fatemeh shirvanizadeh Arani
1st Hekmat Alley.Motahari blvd
Aran and bidgol Iran (Islamic Republic of) 8741646949 +98 31 5472 5800 dr.shirvanizade@gmail.com Yazd University of Medical Sciences scientific Fateme shirvani zade Arani
Hekmat1 Alley, Motahari Blvd
Aran and bidgol Iran (Islamic Republic of) 8741756791 +98 31 5472 5800 dr.shirvanizade@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Married women with type 2 diabetes and sexual dysfunction HBA1C between 7.1 & 8.53. Age between 25 & 55 years diabetic patients should not have systemic diseases such as liver failure, kidney failure, heart failure, thyroid failure, central nervous system disorders, or retinopathy. Absence of pregnancy and breastfeeding Absence of Ovariectomy history and Ovarian agenesis Having a stable life with his wife Married for at least one year 25 years 55 years Female Diagnosis of having chronic diseases affecting sexual function in the patient or his partner during the study (such as cardiovascular or mental or thyroid disorders, cancers) taking drugs that affect sexual performance The occurrence of an unfortunate incident such as the loss of partner or close relative during the study vaginal bleeding, dyspareunia, vaginismus Getting pregnant Menopause E11.8 Type 2 diabetes mellitus with unspecified complications Treatment - Drugs Placebo The intervention group consumes 500 mg herbal tablets three times a day. The drug is prescribed to patients for 8 weeks by a non-researcher, based on masking. The raw materials of this product, which include carrot seeds and fenugreek seeds, are first subjected to quality control tests, including the amount of waste particles, moisture, total ash, and determining the amount of an indicator substance or total essential oil. After determining the quality of each plant, 250 mg of 5% fenugreek seed extract (Fenugreek seed extract) is mixed with 250 mg of carrot seed powder and then sieved and produced in the form of 500 mg tablets with a press machine. The control group consumes 500 mg placebo tablets made of starch but with a completely similar appearance to the drug three times a day. The placebo is prescribed to patients for 8 weeks by a non-researcher. Sexual function. Timepoint: At the beginning of the study and after two months of taking the drug. Method of measurement: Questionnaire. FBS. Timepoint: At the beginning of the study and 60 days after starting to take the drug. Method of measurement: Lab test. 2 hours post prandial blood sugar. Timepoint: At the beginning of the study and 60 days after starting to take the drug. Method of measurement: Lab test. HB A1C. Timepoint: At the beginning of the study and 60 days after starting to take the drug. Method of measurement: Lab test. Mental health. Timepoint: At the beginning of the study and 60 days after starting to take the drug. Method of measurement: questionare. Yazd University of Medical Sciences Approved 2023-03-05 Ethical Committee of Shahid Dr. Rahnamun Hospital, Yazd Motahari Blvd., end of 1st Hekmat Alley Aran and bidgol Isfehan Iran (Islamic Republic of)