Health Condition 1: M638- Disorders of muscle in diseases classified elsewhere Health Condition 2: null- fibromyalgia
Conditions
Interventions
Intervention1: Milnacipran 100 mg/day: Milnacipran 100 mg/day, single tablet (50mg) is given orally twice a day at morning and night after food. The tablet is continued for duration of three months.
C
Sponsors
DrAnithaE
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the improvement in pain response profile in patients with fibromyalgia treated with duloxetine or milnacipranTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Effect of drugs on decreasing frequency of attacks. 2. Effect of drugs based on decrease in duration of attacks. 3. Effect of drugs on decreasing severity of attacks. 4. Adverse event that occurred during the treatment course. 5. Effect of drugs on the number of analgesic consumption. Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactANITHA E
Sri Ramachandra Medical College and Research Institute
Outcome results
None listed