To compare the effect of duloxetine and milnacipranin fibromyalgia patients

Phase 3

Completed

• Conditions: Health Condition 1: M638- Disorders of muscle in diseases classified elsewhereHealth Condition 2: null- fibromyalgia

• Registration Number: CTRI/2017/11/010720
• Lead Sponsor: DrAnithaE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-12-31
• Last Update Posted: 2021-11-24

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 86

Inclusion Criteria

1.Patients diagnosed as fibromyalgia by the physician are only taken for study(meet criteria for fibromyalgia as defined by the American College of Rheumatology (ACR),with or without MDD)

2.Age 18-65 years, both genders (male and female).

3.Patients fulfilling the eligibility criteria who understood the study related procedures and would be available during the treatment period.

4.Patients who are willing to participate in the study by voluntarily signing the informed consent form.

5.Simple randomization done by computer generated randomization software and divided into two groups.

6.No other form of long term drugs for fibromyalgia were permitted except for rescue medications like NSAIDs during acute attacks.

7.Patients were followed up every 15 days. Headache diary maintained.

8.Patients diagnosed by physician are only recruited for study.

9.Patients fulfilling the eligibility criteria who understood the study related procedures and would be available during the treatment period.

Exclusion Criteria

1.Patients who are allergic to either duloxetine or milnacipran.

2.pain symptoms related to traumatic injury, structural or regional rheumatic disease (such as osteoarthritis, bursitis, tendonitis)

3.Patients taking other prophylactic medication were asked to stop 2 weeks prior to the start of the study.

4.Serious medical illness including Hepatic or renal dysfunction, heart diseases, hypertension and diabetes mellitus, migraine and glaucoma.

5.current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, autoimmune disease

6.Women in childbearing age were allowed to take oral contraceptives and who intend to get pregnant were not included in the study.

7.Pregnant and lactating women.

8.If the patient is on tab.thionidazine or other antidepressant drugs

9.Subject who is currently enrolled in another investigational drug study

Study & Design

• Study Type: Interventional
• Study Design: Not specified