A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORTHOHERB TABLET
Phase 4
- Conditions
- Health Condition 1: M172- Bilateral post-traumatic osteoarthritis of kneeHealth Condition 2: M170- Bilateral primary osteoarthritis of kneeHealth Condition 3: M179- Osteoarthritis of knee, unspecifiedHealth Condition 4: M174- Other bilateral secondary osteoarthritis of kneeHealth Condition 5: M06- Other rheumatoid arthritisHealth Condition 6: M171- Unilateral primary osteoarthritisof knee
- Registration Number
- CTRI/2021/07/034634
- Lead Sponsor
- Pankajakasthuri Herbals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Age: 35 -70 years
2.Willing to take Orthoherb tablets in a dose of 2 tablets twice daily after food.
3.Subjects who have started taking Orthoherb tablets within two months.
4.Having one or more joint pain
5.Willing to enroll in study by signing Informed consent
Exclusion Criteria
1.Earlier participation in this study
2.Subjects using Orthoherb tablets since more than two months
3.Pain is of acute onset or due to trauma/injury
4.Unable to respond properly for questionnaire or when a patient is too severely ill to answer the questions
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Reconfirming the efficacy of Orthoherb tablet in joint pain and disorders. <br/ ><br>2. Ensuring safety of Orthoherb tablet and oil on prolonged use. <br/ ><br>3. Incidence of adverse effects or adverse events in users of Orthoherb tablet.Timepoint: 0th and first. o base line values and 1st observations on the time of survey. <br/ ><br>Second on the end of the study for cohort group in 3 month
- Secondary Outcome Measures
Name Time Method 1. Assessing additional therapeutic benefits of Orthoherb tablet. <br/ ><br>2. Reconsider the need of pharmaceutical modification of the product to increase patient compliance if requiredTimepoint: 0th and first. o base line values and 1st observations on the time of survey. <br/ ><br>Second on the end of the study for cohort group in 3 month