Efficacy of Vatantak Gold Tablet and Pain Kill Oil in painful inflammatory Musculoskeletal Conditions

Phase 4

Conditions: Health Condition 1: R298- Other symptoms and signs involvingthe nervous and musculoskeletal systems

Registration Number: CTRI/2022/11/047342

Lead Sponsor: Med Pharma CRO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients 18 years or older, with musculoskeletal pain.

2.Patients willing to give written informed consent.

3.Patients are fit and no need for any hospital administration.

4.Agree to following instruction of doâ??s and donâ??ts in regular daily lifestyle.

5.Patients willing to perform all study related procedures including the use of study medicine, allow the physical and Biochemical tests and willing to document symptoms and medication.

Exclusion Criteria

1.Use of steroids and/or recreational drugs in the past 6 months.

2.Patients with open wounds or infection at the application site.

3.Patients with renal impairment.

4.Patients will be also excluded if they have poorly controlled diabetes mellitus.

5.Female patients who are pregnant.

6.Unstable medical or psychiatric illness.

7.Chronic & acute disorders requiring hospital admission.

8.Known HIV-positive, Hepatitis B or C status.

9.Inability to carry out visits for the study.

10.Inability to maintain current medication regimen.

11.Inability or unwillingness to participate in all components of the study.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Pain Score (VAS and NPRS) <br/ ><br>2.Disease activity based on questionnaires(QoL) <br/ ><br>3.Blood tests: ESR, RA factor, CRP, Serum Uric Acid <br/ ><br>(At baseline and after 60 days of treatment) <br/ ><br>Timepoint: At baseline and after 60 days of treatment <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Quality of Life <br/ ><br>2.Drug safety: RFT & LFT <br/ ><br>3.Incidence of Adverse events (AE) and Serious Adverse Events (SAE) during the study period <br/ ><br>(From Baseline to 60 days of treatment) <br/ ><br>Timepoint: From Baseline to 60 days of treatment