Efficacy of Echium Amoenum on the level of anxiety, perceived stress and occurrence of menstruatio

Phase 3

Recruiting

• Conditions: Condition 1: Anxiety. Condition 2: Stress. Condition 3: Oligomenorrhea.; Anxiety disorder, unspecified; Acute stress reaction; Secondary oligomenorrhea; F41.9; F43.0; N91.4

• Registration Number: IRCT20230417057944N1
• Lead Sponsor: Gonabad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

Women of reproductive age between 18-40 years
Willingness and informed consent to participate in research
Negative pregnancy test
Menstrual cycle delay according to the average period of each person's menstrual cycle in the last six months
History of postponing menstrual bleeding for intervals of 36 days to 6 months

Exclusion Criteria

Smoking, drugs and alcohol
The existence of underlying medical diseases and disorders related to the reproductive system based on individual statement.
BMI less than 18
Lactation amenorrhea
Suffering from known mental disorders other than stress and anxiety based on the person's statements and scores obtained from the Hamilton Anxiety Rating Scale (HARS) and Cohen's perceived stress questionnaires.
Being allergic to Echium Amoenum
Doing sports professionally
The presence of nutritional disorders such as bulimia nervosa and anorexia nervosa or malnutrition based on the person's statements
Taking hormonal, antihypertensive and depression and herbal medicines
Having primary amenorrhea.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety mean. Timepoint: At the beginning of the study, 7, 14, 21, 28, 35, 42 days after starting to take the capsule of Echium Amoenum. Method of measurement: Hamilton Anxiety Rating Scale.;Perceived Stress mean. Timepoint: At the beginning of the study, 7, 14, 21, 28, 35, 42 days after starting to take the capsule of Echium Amoenum. Method of measurement: Cohen perceived stress scale.

Secondary Outcome Measures

Name	Time	Method
Occurrence of menstruation in a patient with oligomenorrhea or secondary amenorrhea. Timepoint: 3-7 days after starting to take the capsule of Echium Amoenum, during the period of taking the medicine, 4 weeks after stopping the capsule. Method of measurement: Questionnaire for recording the daily state of menstruation.