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IRCT20220628055302N1 IRCT 2022-07-23 Mashhad University of Medical Sciences Evaluation the effect of jujube and lemon balm extracts in patients with chronic obstructive pulmonary disease Evaluation the effect of jujube and lemon balm extract accompanying anxiety symptoms and respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD) 2023-01-28 anticipated 60 Complete https://irct.ir/trial/64674 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into Intervention and control groups in blocked randomization model by using the random numbers table and Random Allocation Software. 16 blocks of 4 will be produced and the sequence produced by the design statistician will be placed in opaque sealed envelopes and numbered, respectively, Blinding description: Participants, researcher and outcome assessor are unaware of the individuals assigned to the intervention and control group. Clinical supervisor and sample allocator to the groups are aware of the control and intervention group.The drug used in both intervention and control groups will be similar in terms of shape and appearance. 3 Chronic Obstructive Pulmonary Disease. Intervention 1: Intervention group: Hydroalcoholic extract of jujube and lemonbalm in the form of capsules 750 mg twice a day for 6 weeks. Intervention 2: Control group: placebo(Avisel) capsule for 6 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 I have not decided yet - its release schedule is not yet known
public Samane Mousapoor
Azadi Square, east door of the university campus, Faculty of Iranian and Complementary Medicine, Mashhad
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8931 mousapours981@mums.ac.ir Mashhad University of Medical Sciences scientific Dr.Roshanak Salari
Azadi square, university campus, School of Persian and complementary medicine
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3884 8930 SalariR@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) People aged 40 to 70 with COPD, whose disease has been confirmed by a lung specialist COPD patients who did not have a known anxiety disorder and were not under standard psychiatric treatment, but had a score of 8 or higher based on the HADS questionnaire People who are satisfied with traditional treatment 40 years 70 years Both Pregnancy and breastfeeding A history of severe anxiety that requires classical medical treatment People who are under the supervision of a psychiatrist or take psychiatric medication due to a known anxiety or mood disorder People who have severe anxiety in the screening tests will be referred to a psychiatrist for diagnostic evaluation and standard treatment Suffering from other medical diseases including hypothyroidism j44.9 Chronic obstructive pulmonary disease, unspecified Treatment - Drugs Placebo Intervention group: Hydroalcoholic extract of jujube and lemonbalm in the form of capsules 750 mg twice a day for 6 weeks Control group: placebo(Avisel) capsule for 6 weeks Anxiety score in HADS anxiety subscale questionnaire. Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th week. Method of measurement: HADS anxiety subscale questionnaire. Anxiety score in Spielberger's Clear and Hidden Anxiety Questionnaire (STAI). Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th week. Method of measurement: Spielberger state anxiety questionnaire. CAT score. Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th week. Method of measurement: CAT test. Distance traveled in the 6MWT. Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th. Method of measurement: 6-minute walk test (6MWT). Number of times sitting and getting up in the chair. Timepoint: At the beginning of the study (before the intervention) and the 3rd and 6th. Method of measurement: 1-min sit-to-stand test (STST). Blood oxygen saturation (SaO2). Timepoint: At the beginning and end of each round of the (STST) and (6MWT). Method of measurement: Pulse oximeter device. Pulse rate. Timepoint: At the beginning and end of each round of the (STST) and (6MWT). Method of measurement: Pulse oximeter device. Quality of Life score on WHO Quality of Life Questionnaire (Bref-WHOQol). Timepoint: Before and after intervention. Method of measurement: WHO Quality of Life Questionnaire. Mashhad University of Medical Sciences Approved 2022-06-11 The Ethics Committee of Mashhad University of Medical Sciences Mashhad Univercity Of Medical Sciences, University StreetThe Ethics Committee of Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)