Health Condition 1: M628- Other specified disorders of muscle
Conditions
Interventions
Intervention1: DAN-SP: DAN SP is the fixed dose combination of Paracetamol,Serratiopeptidase and Diclofenac providing anti- inflammatory, analgesic, and anti-pyretic effect. The combination of the dru
Sponsors
Unison Pharmaceuticals Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 01.Patients who have given their written consent to participate voluntarily and understand to adhere to protocol for completion of study. 02. Age 18.00 Years to 65.00 Years (inclusive both). 03. Patient is able to take oral medication and willing to adhere to schedule of treatment. 04.Patient’s willingness to comply with all study procedures and availability for the duration of the study. 05. If male, must agree to use a reliable contraception method (i.e., abstinence, condom or partner using an IUD) 06. If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e., abstinence, intrauterine device [IUD], orpartner agreeing to use male-condom). 07.Patients diagnosed (by the treating physician/PI) to have Acute Painful musculospastic condition such as prolapsed intervertebral disc, sprains and dislocations, spondylosis (lumbar, cervical, ankylosing spondylosis), spinal stenosis, periarthritis, frozen shoulder, prepatellar bursitis, spondylolisthesis, low-backpain, tendonitis, tenosynovitis, bursitis, and as self-rated by the patient 7 to 10 on Numerical pain scale. 08. Patients must agree to not consume Alcohol, any other substance of abuse during their participation in the trial.
Exclusion criteria
Exclusion criteria: 1. Active participation in any other clinical trial or in last three months. 2. Known allergy to the study drugs used in the trial. (Serratiopeptidase, Paracetamol, Diclofenac). 3. Patients with any other clinically significant uncontrolled systemic diseases such as gastrointestinal, respiratory, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy as judged by the investigator. 4. History of auto-immune disease. 5. Patients with the history of epilepsy, or those at risk seizures or taking seizure drugs in pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 6. Patients with galactose or fructose intolerance. 7. Patients with severe renal impairment, including those receiving dialysis. 8. Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities. 9. Patients with pre-existing gallbladder disease. 10. Active peptic ulcer disease. 11. Patients taking any other medicines that might interact with one of the study medications. 12. Patient with known G6PD deficiency. 13. Alcohol dependence, chronic malnutrition or dehydration, severe hypovolaemia (IV) or any other condition which may interfere with the study, as judged by the Investigator. 14. Patients with concomitant use of other NSAIDs, corticosteroids, antiplatelets, anticoagulants or any other aid for pain. 15. Patients needing any treatment (associated with acute lower backache associated with muscle spasm) other than the study drugs - as diagnosed by the Investigator. 16. Any history/ symptoms/ suspicion of patients having hepatic or renal impairment, as judged by the Principal Investigator. 17. If patient is on any other treatment or additional treatment aid for pain (oral, dermal, drug-plaster, heat-pad or any similar contact therapy, herbal, homeopathic or any other nature) during the study duration. 18. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the patient’s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage reduction in pain at day 8. 2. Percentage of the patients where the PI stops the treatment before the day 8, as the pain has subsided & the need for pain management does not exist anymore.Timepoint: 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients who shows any incidence of drug associated adverse effect. 2. Percentage of patients where the PI needs to stop the treatment before day 8 due to drug associated toxicity.Timepoint: 8 days | — |
Countries
India
Contacts
Public ContactBharat B Doshi
BioDev Services Private Limited
Outcome results
None listed