A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORTHOHERB TABLET

RETROSPECTIVE, CROSS SECTIONAL AND PROSPECTIVE OBSEVATIONAL STUDY TO EVALUATE ORTHOHERB TABLET THROUGH POST MARKETING SURVEILLANCE STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/07/034634

Enrollment

1500

Registered

2021-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M172- Bilateral post-traumatic osteoarthritis of knee Health Condition 2: M170- Bilateral primary osteoarthritis of knee Health Condition 3: M179- Osteoarthritis of knee, unspecified Health Condition 4: M174- Other bilateral secondary osteoarthritis of knee Health Condition 5: M06- Other rheumatoid arthritis Health Condition 6: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Orthoherb tablet: A dose of 2 tablets twice daily after food Control Intervention1: Not applicable: Not applicable

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Reconfirming the efficacy of Orthoherb tablet in joint pain and disorders. 2. Ensuring safety of Orthoherb tablet and oil on prolonged use. 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. Second on the end of the study for cohort group in 3 month	—

Secondary

Measure	Time frame
1. Assessing additional therapeutic benefits of Orthoherb tablet. 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. Second on the end of the study for cohort group in 3 month	—

Countries

India

Contacts

Public ContactMr Arun Visakh Nair

Pankajakasthuri Herbal research Foundation

drshan@phkil.com9188325339

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026