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Effects of Sophora alopecuroides var. alopecuroides on the heroin withdrawal symptoms

Comparison of the effect of Sophora alopecuroides var. alopecuroides and placebo on the clinical opiate withdrawal scale in heroin addicts: a clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090804002288N16
Enrollment
100
Registered
2020-02-15
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-02-24

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

Conditions

Heroin addiction. Opioid dependence with withdrawal

Interventions

Intervention 1: Intervention group: fifty patients use three 400 mg capsules of the Sophora alopecuroides var. alopecuroides seed hydro-alcoholic extract once orally every 24 hours for 8 days. The ext

Sponsors

Vice Chancellor for Research, Research Institute for Islamic and Complementary Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Iranian male outpatients who according to the DSM-V criteria are dependent on heroin for at least 1 year Patients whose urinalysis result for detection of 6-acetylmorphine is positive Patients aged 18 to 70 years Patients whose heroin dose has been constant for at least one month before study Patients residing in addiction treatment camp Patients who have not used heroin for at least 5 hours before arrival in camp

Exclusion criteria

Exclusion criteria: Individuals who besides heroin abuse other substances except for tobacco Patients who have other psychiatric diseases Individuals who have other important diseases like cardiac, renal and hepatic disease Individuals who have organic brain disease Individuals who have mental retardation

Design outcomes

Primary

MeasureTime frame
Score of clinical opiate withdrawal scale. Timepoint: Before intervention and 3 and 8 days after intervention. Method of measurement: Clinical Opiate Withdrawal Scale.;Patient global impression regarding efficacy of treatment. Timepoint: Eight days after intervention. Method of measurement: Visual analog scale (ten centimeter ruler).

Secondary

MeasureTime frame
Blood level of aspartate aminotransferase. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.;Blood level of alanine aminotransferase. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.;Blood level of alkaline phosphatase. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.;Blood level of total bilirubin. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.;Blood level of direct bilirubin. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.;Blood level of indirect bilirubin. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.;Prothrombin time. Timepoint: Before intervention and 8 days after intervention. Method of measurement: chronometer.;Blood level of creatinine. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.;Level of blood urea nitrogen. Timepoint: Before intervention and 8 days after intervention. Method of measurement: Spectrophotometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Saeed Kianbakht

Iranian academic center for education culture and research

kianbakht@imp.ac.ir+98 26 3476 4010

Outcome results

None listed

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