Comparison of different Aspirin in diabetic patients.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/09/009673
• Date of registration: 06-09-2017
• Prospective Registration: No
• Primary sponsor: Dr Kanharam Patel
• Public title: Comparison of different Aspirin in diabetic patients.
• Scientific title: Comparison of anti-platelet efficacy of four different marketed formulations of Aspirin in diabetic patients.
• Date of first enrolment: 11-02-2015
• Target sample size: 120
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12101
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Investigator Blinded
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Dr B R Daswani
• Affiliation: B. J. Govt. Medical College and Sassoon Gen. Hospital

• Name: KANHARAM NARAYAN PATEL
• Affiliation: B. J. Govt. Medical College and Sassoon Gen. Hospital

Key inclusion & exclusion criteria

Inclusion criteria: Patients with Type 2 DM receiving oral anti-diabetic with dietary modifications and who have two or more risk factors for cardiovascular disease.
Exclusion criteria: Patients having age <40 yrs.

Uncontrolled diabetes mellitus (Fasting BSL > 300 mg/dL Despite therapy)

Uncontrolled Hypertension

Abnormal Liver Function Tests and/or Renal Function Tests.

Patients receiving any form or dose of Aspirin therapy for >7 days

Patient receiving any other antithrombotic or anti-coagulant therapy.

Patients having deranged bleeding and/ or clotting time at baseline study.

Patient on insulin.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients with Type 2 DM receiving oral anti-diabetic and who have two or more risk factors for cardiovascular disease

Intervention(s)

Intervention1: Acetyl salicylic acid 150mg plain: Plain Acetyl salicylic acid 150mg
Frequency: once a day at morning on empty stomach.
Route of Administration: Oral
Total duration of therapy: 14 Days

Control Intervention1: Aspisol 150 mg: Soluble acetyl salicylic acid 150 mg
Frequency: once a day at morning on empty stomach.
Route of Administration: Oral
Total duration of therapy: 14 Days

Control Intervention2: Colsprin 150 mg: Effervescent acetyl salicylic acid 150 mg
Frequency: once a day at morning on empty stomach.
Route of Administration: Oral
Total duration of therapy: 14 Days

Control Intervention3: Ecosprin 150 mg: Enteric coated acetyl salicylic acid 150 mg
Frequency: once a day at morning on empty stomach.
Route of Administration: Oral
Total duration of therapy: 14 Days

Primary Outcome(s)

ADP induced platelet aggregationTimepoint: Day 0 Day 15

Secondary Outcome(s)

Bleeding Time

Steady state plasma salicylate concentrationTimepoint: Day 0 Day 15

Secondary ID(s)

NIL

Source(s) of Monetary Support

Dr Kanharam Patel A-2/4, Lower Indiranagar, Bibwewadi, Pune 411037. 9960611941

Ethics review

Status: Approved
Approval date: 26/09/2014
Contact:

INSTITUTIONAL ETHICAL COMMITTEE, B J GOVT MEDICAL COLLEGE AND SASSOON GENERAL HOSPITAL, PUNE

Results

• Date Completed: 24/08/2016