Post marketing study to validate the efficacy and safety of Pravek Rumakalp for the treatment of musculoskeletal pain.

Phase 4

• Conditions: Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

• Registration Number: CTRI/2023/10/059140
• Lead Sponsor: Pravek Kalp (P) Limite

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Subjects of either sex in the age range of 18 to 60 years (both

inclusive)

2. Subjects able and willing to give written informed consent form.

3. Subjects suffering from acute pain and inflammation associated

with prolapsed intervertebral disc, sprains and dislocations,

spondylosis (lumbar, cervical, ankylosing spondylosis), spinal

stenosis, periarthritis, frozen shoulder, prepatellar bursitis,

spondylolisthesis, Low-back pain, tendonitis, tenosynovitis,

bursitis.

Exclusion Criteria

1. Subjects known, or thought to be hypersensitivity to study drugs

2. Subjects with concurrent use of corticosteroids

3. Subjects with medication or indication that might point to an

increased risk, associated with study participation or study drug

administration or may interfere with the interpretation of study

results and, in the judgment of the study personnel, would make

the subject in appropriate for inclusion

4. Subjects participated in other clinical trials from last three

months or during study participation

5. Subjects with history of epilepsy or at risk of seizures or taking

anti-epileptic drugs

6. Pregnant, lactating women or women of child bearing age who

are not using an acceptable method of birth control

7. Subjects with galactose or fructose intolerance

8. Subjects with severe renal impairment, including those receiving

dialysis.

9. Subjects with active liver disease, including those with primary

biliary cirrhosis and unexplained persistent liver function

abnormalities.

10. Subjects with pre-existing gall bladder disease

11. Subjects with active peptic ulcer disease

12. Pre or post-surgical cases

Study & Design

• Study Type: PMS
• Study Design: Not specified