The effect of valerian on sleep quality, anxiety and depression in hemodialysis' patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201601286318N5

Enrollment

Registered

2016-02-04

Start date

2016-02-13

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis patients. Dementia in other specified diseases classified elsewhere

Interventions

Intervention 1: Group A use Valerian capsules (Sedamin 530 mg, Goldaru Co.) 60 minutes before bedtime for one month. After one month cleaning, group A will receive placebo. Participants complete quest

Group A use Valerian capsules (Sedamin 530 mg, Goldaru Co.) 60 minutes before bedtime for one month. After one month cleaning, group A will receive placebo. Participants complete questionnaires of qua

Group B uses placebo capsules (starch 50 mg, Goldaru Co.) 60 minutes before bedtime for one month. After one month cleaning, group B will receive Valerian capsules (Sedamin 530 mg, Goldaru Co.). Parti

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Over 18 years of age; hemodialysis 3 times a week for 3 hours; for more than 3 months; full consciousness; hearing and speech ability; and not having sensitivity to plants. Exclusion criteria: Physical or mental disability; drug abuse; cancer; hearing or visual disorder; experienced recent stressful event; kidney transplant; acute illness; body mass index over 30; liver disease; hepatitis; cirrhosis; travel; or death of the patient.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep quality. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: In this study, sleep quality is measured by using Pittsburgh Sleep Quality Index. This measurement is performed within three consecutive months (before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention). Scores above 5 indicates that a person has trouble in sleeping. Information for each person will be recorded in a specific questionnaire for each patient.;Situational anxiety. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: The state of anxiety is measured by using anxiety STAI questionnaire. In response to the scale of anxiety, the participants expressed their feelings at that moment. This measurement is performed within three consecutive months (before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention). This is a self-report questionnaire to assess anxiety, which has twenty 4 choice questions, which is scored by Likert scoring scale. The scale scores ranges from 20 to 80. Based on the score obtained, each person is placed in one of the 3 anxiety groups of mild (20-39), moderate (40-59) or severe (60-80). Information for each person will be recorded in a specific questionnaire for each patient.;Depression. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: Depression is measured by using Beck Depression Inventory. Beck Depression Inventory tests their polls. This measurement is performed within three consecutive months (before the intervention, one month after the first inte	—

Measure

Time frame

Sleep quality. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: In this study, sleep quality is measured by using Pittsburgh Sleep Quality Index. This measurement is performed within three consecutive months (before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention). Scores above 5 indicates that a person has trouble in sleeping. Information for each person will be recorded in a specific questionnaire for each patient.;Situational anxiety. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: The state of anxiety is measured by using anxiety STAI questionnaire. In response to the scale of anxiety, the participants expressed their feelings at that moment. This measurement is performed within three consecutive months (before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention). This is a self-report questionnaire to assess anxiety, which has twenty 4 choice questions, which is scored by Likert scoring scale. The scale scores ranges from 20 to 80. Based on the score obtained, each person is placed in one of the 3 anxiety groups of mild (20-39), moderate (40-59) or severe (60-80). Information for each person will be recorded in a specific questionnaire for each patient.;Depression. Timepoint: Before the intervention, one month after the first intervention, one month after the cleansing and one month after the second intervention. Method of measurement: Depression is measured by using Beck Depression Inventory. Beck Depression Inventory tests their polls. This measurement is performed within three consecutive months (before the intervention, one month after the first inte

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonir Nobahar

Semnan University of Medical Sciences

nobahar43@semums.ac.irNobahar43@yahoo.com+98 23 3365 4170

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026