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A POST MARKETING SURVEILLANCE STUDY TO EVALUATE THE SAFETY AND EFFICACYOF ORTHOHERB OIL

RETROSPECTIVE, CROSS SECTIONAL AND PROSPECTIVE OBSEVATIONAL STUDY TOEVALUATE ORTHOHERB OIL THROUGH POST MARKETING SURVEILLANCE STUDY

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/034635
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: M06- Other rheumatoid arthritis Health Condition 5: M173- Unilateral post-traumatic osteoarthritis of knee Health Condition 6: M171- Unilateral primary osteoarthritisof knee

Interventions

Intervention1: Orthoherb oil: Applying Orthoherb oil externally at least one time per day Control Intervention1: Not applicable: Not applicable

Sponsors

Pankajakasthuri Herbals India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1.Reconfirming the efficacy of Orthoherb oil in joint pain and disorders. 2.Ensuring safety of Orthoherb oil on prolonged use. 3.Incidence of adverse effects or adverse events in users of Orthoherb oil Timepoint: oth-baseline 1st-first response to questionnaire and 2nd -response at the end of the study

Secondary

MeasureTime frame
1. Assessing additional therapeutic benefits of Orthoherb oil. 2. Reconsider the need of pharmaceutical modification of the product to increase patient compliance if required. Timepoint: oth-baseline 1st-first response to questionnaire and 2nd -response at the end of the study

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