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IRCT20210622051660N1 IRCT 2021-07-15 Mashhad University of Medical Sciences Evaluation of the effect of Gaznab herbal product on the control of primary hypertension Evaluation of the effect of adding Gaznab herbal product to standard treatment in patients with primary hypertension compared to placebo 2021-07-17 anticipated 36 Complete https://irct.ir/trial/57386 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into control and intervention groups using random blocking method by www.sealedenvelop.com. How to hide the allocation with the envelope method is sealed opaque and sealed, Blinding description: In this study, patients are unaware that they are assigned to the control or intervention group. intervention group will be given Gaznab herbal syrup and continuation of previous drugs and the control group will be given placebo syrup and continuation of previous drugs(in the same package and color). The outcome assessor as well as the data analyst are unaware of which group the patient belongs to. 3 Hypertension. Intervention 1: Intervention group: Gaznab syrup containing aqueous extract of jujube with a concentration of 15% w / v and nettle with a concentration of 10% w / v 2 times a day and each time 10 cc for 8 weeks. Intervention 2: Control group:Placebo syrup of the same shape and color with the same packaging and 2 times a day and each time 10 cc for 8 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Batool Jalalkamali
Mashhad Faculty of Iranian and Complementary Medicine, University Campus, East Door, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3891 0394 jalalkb1@mums.ac.ir Mashhad University of Medical Sciences scientific Malihe Motavasselian
Faculty of Iranian and Complementary Medicine, East Gate of the University Campus, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8930 MotavasselianM@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Men and women aged 30-65 years Hypertension grade1 with pressure equal to or greater than 140.90 mmHg to 159.99 mmHg Are treated with a blood pressure medication (one to three drugs based on the protocol). BMI greater than or equal to 27 At least one month has passed since starting the medication The person should not be at high risk (diabetes mellitus and end organ damage , etc.) 30 years 65 years Both History of hypo or hyperthyroidism Types of cardiac dysrhythmias (such as second and third degree block) Allergy to medicinal plants History of potassium greater than 5.1 or less than 3.5 m Eq / L at the first visit Warfarin consumption Pregnancy or lactation History of hypermenorrhea in females Presence of blood pressure greater than or equal to 180/110 mm Hg The presence of any medical or surgical disorder that could interfere with the study. I10 Essential (primary) hypertension Treatment - Drugs Placebo Intervention group: Gaznab syrup containing aqueous extract of jujube with a concentration of 15% w / v and nettle with a concentration of 10% w / v 2 times a day and each time 10 cc for 8 weeks Control group:Placebo syrup of the same shape and color with the same packaging and 2 times a day and each time 10 cc for 8 weeks Blood pressure. Timepoint: In baseline and after 4 week and after 8 week. Method of measurement: Sphygmomanometer. FBS, BUN, Cr, TG, Cholesterol, SGOT, SGPT, CBC. Timepoint: Beginning and end of the study (after 8 weeks). Method of measurement: Biochemical and Hematological blood check. Quality of life score. Timepoint: pretest, post-test (at the end of 8 weeks). Method of measurement: The World Health Organization Quality of Life Questionnaire. Stress, Anxiety and Depression score. Timepoint: pretest, post-test (at the end of 8 weeks). Method of measurement: DASS21 Questionnaire. Mashhad University of Medical Sciences Approved 2021-06-19 Ethics committee of mashhad University of Medical Sciences Mashhad Univercity Of Medical Sciences, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)