To evaluate the efficacy and safety of the product Dr. Ortho Capsules in patient suffering from Knee pain, Stiffness in Joints, Arthritis, Bulky Shoulder And Inflammation in Joints, Acute Sports Injury, Strains & Sprain.

A Single Centric, Open-Label, Non-Randomized Phase IV Post-Marketing Surveillance Study to Measure the Efficacy and Safety of Dr. Ortho Capsules in Subjects Suffering from Knee Pain, Stiffness in Joints, Arthritis, Bulky Shoulder and Inflammation in Joints, Acute Sports Injury, Strains & Sprain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050809

Enrollment

120

Registered

2023-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: M256- Stiffness of joint, not elsewhereclassified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 18 - 80 Years 2.Subjects suffering from knee pain and joint pain and arthritis 3.Subjects suffering from acute sports injury, strains, sprain, chronic arthritis, back pain, knee pain, and other joint pain. 4.Willingness to take part in study and able to attend all scheduled visits 5.Subjects willing to sign ICF 6.Subjects willing to refrain taking any other similar medication during the study period.

Exclusion criteria

Exclusion criteria: 1.Pregnant, breastfeeding, subjects undergone any surgery and else taken part in any clinical trial 2.Participation in any other clinical study (device or drug) within 30 days prior to Screening; 3.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, hepatic, renal disease, congenital or any other disorder 4.Subject with abnormal lab values detected at the time of screening shall be excluded. 5.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational product. 6.Pre-existing systemic disease necessitating long-term medications. 7.Genetic and endocrinal disorder 8.Not willing to Sign the ICF or give the consent

Design outcomes

Primary

Measure	Time frame
1.To assess the percentage of subjects with significant symptomatic reduction of joint pain, stiffness in joints, arthritis, knee pain, bulky shoulder & inflammation in joints. 2.Improvement in the VAS scoring on the successive application as compared to baselineTimepoint: Day 1 and Day 30	—

Secondary

Measure	Time frame
1.To assess the safety of Dr. Ortho Capsules 2.To assess the percentage of subjects with significant symptomatic reduction of acute sports injury, strains & sprain 3.Incidence of any AEs during the study 4.Improvement in Oswestry Disability Index (ODI)from baseline visit to EOSTimepoint: Day 1 and Day 30	—

Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Divisa Herbals Pvt. Ltd.

admin@xplorahealth.com08042115562

Outcome results