Effect of crocin supplementation in treatment of methadone maintenance treatment patients

A Clinical trial to assess the effect of crocin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170420033551N4

Enrollment

Registered

2018-12-31

Start date

2018-12-13

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Addiction. Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances

Interventions

Intervention 1: Intervention group: tablet of Crocin, 15 mg, two oral tablet for 8 weeks. Intervention 2: Control group: Placebo tablet, two oral tablet for 8 weeks.

Eligibility

Sex/Gender

Male

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Currently undergoing MMT and opioid dependence in the past year Age of 18 to 60 years old Evaluated by the drug abuse section of the Structured Clinical Interview for DSM-IV Beck Depression Scores > 20 and Beck Anxiety > 15 Seeking for treatment

Exclusion criteria

Exclusion criteria: Taking crocin, anti-inflammatory and antioxidant supplements during the last 3 months before the intervention. History of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease.

Design outcomes

Primary

Measure	Time frame
Depression beck score. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire.;Anxiety beck score. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Total antioxidant. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;HDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Expressed levels of PPAR-?. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Total glutathione. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Spectrophotometry.;Expressed levels of TGF-ß gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.	—

Measure

Time frame

Total antioxidant. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;HDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit.;Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Expressed levels of PPAR-?. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Total glutathione. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Spectrophotometry.;Expressed levels of TGF-ß gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.;Expressed levels of LDLR gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5554 0021

Outcome results

None listed

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