A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY AND EFFICACYOF ORTHOHERB OI
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: M06- Other rheumatoid arthritisHealth Condition 5: M173- Unilateral post-traumatic osteoarthritis of kneeHealth Condition 6: M171- Unilateral primary osteoarthritisof knee
- Registration Number
- CTRI/2021/07/034635
- 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 applying Orthoherb oil externally at least one time per day for a continuous period of 6 months
3.Having one or more joint pain
4.Willing to enrol in study by signing Informed consent
Exclusion Criteria
1.Earlier participation in this study
2.Subjects using Orthoherb oil 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 oil in joint pain and disorders. <br/ ><br>2.Ensuring safety of Orthoherb oil on prolonged use. <br/ ><br>3.Incidence of adverse effects or adverse events in users of Orthoherb oil <br/ ><br>Timepoint: oth-baseline <br/ ><br>1st-first response to questionnaire and 2nd -response at the end of the study
- Secondary Outcome Measures
Name Time Method 1.Assessing additional therapeutic benefits of Orthoherb oil. <br/ ><br>2.Reconsider the need of pharmaceutical modification of the product to increase patient compliance if required. <br/ ><br>Timepoint: oth-baseline <br/ ><br>1st-first response to questionnaire and 2nd -response at the end of the study