Effect of gabapentin on heart rate variability in diabetic painful peripheral neuropathy: a double blinded randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201212019014N14

Enrollment

Registered

2012-12-31

Start date

2012-12-21

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

painful peripheral neuropathy. Diabetic autonomic neuropathy

Interventions

Intervention 1: gabapentin capsule 100 mg in the first day, 200 mg in the second day, and 300 mg daily from third day for three months plus moisturizing cream (as placebo) with a phalanx size three t

Treatment - Drugs

Placebo

gabapentin capsule 100 mg in the first day, 200 mg in the second day, and 300 mg daily from third day for three months plus moisturizing cream (as placebo) with a phalanx size three times a day for t

capsule like gabapentin including starch (as placebo) daily for three months plus Kapsycin cream for reducing pain with a phalanx size three times a day for three months

Eligibility

Sex/Gender

All

Age

18 Years to 139 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: the patients of 18 years or older with painful peripheral neuropathy Exclusion criteria: (a) previous history of cardiac arrhythmia, valvular heart disease, heart block, symptomatic ischemic heart disease; (b) open-heart surgery; (c) using anti- arrhythmia, beta blockers, tricyclic antidepressants and phenothiazines drugs; (d) pregnancy and lactation; (e ) history of major depression, (f) ESRD; (g) allergy to gabapentin; and (h) Unstable general condition

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Standard deviation of N-N (SDNN). Timepoint: 3 months after intervention. Method of measurement: 24 hours holter monitoring device.	—

Secondary

Measure	Time frame
Orthostatic hypotension. Timepoint: 3 months after intervention. Method of measurement: Mercury sphygmomanometer.;Resting tachycardia. Timepoint: 3 months after intervention. Method of measurement: Mercury sphygmomanometer.;Any adverse events. Timepoint: 3 months after intervention. Method of measurement: questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Jalal Poorolajal

Research Center for Health Sciences and Department of Epidemiology & Biostatistics

poorolajal@umsha.ac.ir+98 81 1838 0090

Outcome results

None listed

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