Effect of melatonin supplementation in treatment of patients with Parkinson's disease

Clinical trial of the effect of melatonin supplementation compared with the placebo on clinical status, metabolic profiles and gene expression related to inflammation, insulin and lipid in patients with Parkinson's disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N29

Enrollment

Registered

2018-01-23

Start date

2018-01-02

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

Parkinson's disease. Parkinson's disease

Interventions

Intervention 1: Intervention group: Melatonin supplements (Zahravi, Tabriz, Iran), 5 mg, two capsules one hour before bedtime for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence

Eligibility

Sex/Gender

All

Age

50 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with Parkinson' disease. Individuals aged 50 to 90 years.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Unwillingness to cooperate

Design outcomes

Primary

Measure	Time frame
Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: ELISA test.	—

Secondary

Measure	Time frame
BDI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questioner.;UPDRS. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Physical Examination by Neurologist.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TGF-ß gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measu	—

Measure

Time frame

BDI. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questioner.;UPDRS. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Physical Examination by Neurologist.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TGF-ß gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measu

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

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