Post Marketing Surveillance Study to evaluate safety and efficacy of Phenyramidol Tablet in the treatment of patients suffering from Lumbago, Integumental pain and Musculoskeletal pain.
- Conditions
- Health Condition 1: null- acute Lumbago, acute Integumental and acute Musculoskeletal pain
- Registration Number
- CTRI/2010/091/000376
- Lead Sponsor
- Fermenta Biotech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
i) Patients suffering from acute Lumbago, acute Integumental and acute Musculoskeletal pain.
ii) Patients of either sex between 18 to 60 years of age.
iii) Patients who are willing to take the medications as directed and willing to come for follow-ups.
iv) Patients who comply with the protocol requirements.
v) Patients who give the written informed consent.
vi) Patients or their representative capable of making entry in Patient Diary Card.
i) Patients with hypersensitivity to any of the ingredients of the investigational product.
ii) Patients already on analgesics, muscle relaxants, and tranquilizers 24 hours before first dose of investigational drug.
iii) Pregnant/lactating women.
iv) Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception and 2 weeks following the end of the study therapy.
v) Patients unavailable on phone for follow-up.
vi) Any specific condition which does not justify patient?s inclusion in the study in the opinion of the investigator.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method