Effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy

Effect of coenzyme Q10 versus placebo as an adjuvant therapy on pain in patients with painful diabetic neuropathy: a double-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N385

Enrollment

116

Registered

2021-02-21

Start date

2021-05-05

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Painful diabetic neuropathy. Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified

Interventions

Intervention 1: Intervention group: Pregabalin tablet 75 mg (manufactured by Golden Life Pharmaceutical Co.) every 12 hours for 8 weeks plus coenzyme tablet Q10 100 mg (manufactured by Reyhaneh Pharma

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 70 years, Type 2 diabetes for at least one year, Painful diabetic neuropathy,

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding, Foot ulcer or infection, Hemoglobin A1C equal to or less than 9, Cerebrovascular diseases or discopathy, Taking anti-inflammatory medications, Using alcohol or opioids

Design outcomes

Primary

Measure	Time frame
Mean score of pain. Timepoint: Before the intervention and at weeks 2 and 4 and 8 after the intervention. Method of measurement: using Visual Analog Scale (VAS).;Mean score of sleep disorder. Timepoint: Before the intervention and at weeks 2 and 4 and 8 after the intervention. Method of measurement: Using the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) questionnaires.	—

Measure

Time frame

Mean score of pain. Timepoint: Before the intervention and at weeks 2 and 4 and 8 after the intervention. Method of measurement: using Visual Analog Scale (VAS).;Mean score of sleep disorder. Timepoint: Before the intervention and at weeks 2 and 4 and 8 after the intervention. Method of measurement: Using the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) questionnaires.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactParyan Amini

Hamedan University of Medical Sciences

paryan.amini@yahoo.com+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 13, 2026