A clinical trial to study the effects of two drugs, amitriptyline and pregabalin in patients with chronic low back pain

Efficacy and safety of pregabalin vs amitriptyline in chronic low back pain â?? A randomized control trial - no

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/07/002833

Enrollment

100

Registered

2012-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- chronic low back pain

Interventions

Intervention1: drug comparison amitriptyline and pregabalin: Pregabalin 75 mg bd for 2 weeks,150 mg bd for 4 weeks 300 mg bd for 8 weeks amitriptylin 12.5 mg od for 2 weeks,25 mg od for 4 weeks 25 m

Eligibility

Inclusion criteria

Inclusion criteria: Chronic low-back pain (symptoms duration > 3 month) Age:[ > 18 yrs to 75 yrs] Informed consent

Exclusion criteria

Exclusion criteria: Previous back surgery Diabetic and other neuropathies Infective or structural diseases of back (e.g. Potts spine , malignancies) Cardiac or renal disease History of gastric ulcers or intestinal bleeding Known allergy to the drugs under study Alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
mean pain reduction and disability improvement following allotted treatment regimenTimepoint: 14 weeks	—

Secondary

Measure	Time frame
adverse effects due to the allotted drugTimepoint: 14 weeks	—

Countries

India

Contacts

Public ContactProff U k misra

head

drukmisra@rediffmail.com8004904627

Outcome results

None listed

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