Valerian for prevention of neuropsychiatric adverse effects of Efavirenz in HIV positive patients

Comparing efficacy and safety of Valerian and Placebo for prevention of Efavirenz-induced anxiety and depression in HIV positive patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201504053449N18

Enrollment

Registered

2015-12-06

Start date

2015-09-23

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

Neuropsychiatric disorders. A cluster of psychotic phenomena that occur during or following drug use

Interventions

Intervention 1: 2 capsules of Sedamin ( 530 mg of dry extract of Valerian root- GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks. Intervention 2: 2 Capsule

Treatment - Drugs

Placebo

2 capsules of Sedamin ( 530 mg of dry extract of Valerian root- GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks.

2 Capsules of Placebo (GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with confirmed HIV infection, between 18-65 years old, receiving Efavirenz containing antiretroviral treatment. Exclusion criteria: Pregnant and lactating women, previous treatment with Efavirenz, positive history of neuropyschiatric disorders such as severe depression, patients who are receiving mood affecting agents (such as Methadone), positive history of hypersensitivity to herbal products including Valerian, discontinuation of antiretroviral therapy by patient due to any reason, patients who do not tolerate side effects of Valerian (headache, vertigo, stomach pain, nausea, vomiting, diarrhea and palpitation).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Depression, Anxiety, Sleep Disturbance. Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis. Timepoint: At baseline and 4 weeks later. Method of measurement: The Hamilton Depression and Anxiety, Pittsburgh Sleep Quality, Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis Scales.	—

Secondary

Measure	Time frame
Safety of Valerian. Timepoint: During the study. Method of measurement: Patients reports and follow up.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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