A randomized, open label, multicentered parallel group clinical study to evaluate the efficacy and safety of Joint Core TM in osteoarthritis patients

A randomized, open Label, multicentered parallel group clinical study to evaluate the efficacy and safety of Joint Core TM (Natural egg shell membrane (Muttai Jow Complex TM) 400 mg + AKBACORE TM Boswellia Serrata (30%AKBA) 90 mg + CUMINCORE TM(Curcumin Extract 96%) 10 mg) compared to Jointace DN (Glucosamine 750 mg + Diacerein 50 mg + msm 250 mg) in osteoarthritis patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035335

Enrollment

Registered

2021-08-02

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Joint Core TM: (Natural egg shell membrane (Muttai Jow Complex TM) 400 mg + ABKACORE TM Boswellia serrata (30%AKBA) 90 mg + CUMINCORE TM (Curcumin extract 96%) 10 mg) Control Interventi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Have osteoarthritis (OA) of the knee joint based on American College of Rheumatology (ACR) criteria and confirmed with X-rays and ACR functional class III and with grade 3 or 4 as per Kellgren and Lawrence classification system 2. Have been on stable dose of prescription Nonsteroidal Anti-Inflammatory Drugs (NSAIDS), or acetaminophen of at least 2000 mg per day for at least 20 days in the past month. 3. Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS) 4. Patient should have not participated in any other clinical trial during the past 3 months. Ki3 14 5. Participants who are willing to give written signed and dated informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Arthritis of the knee from other causes 2. Uncontrolled hypertension or Diabetes 3. Have OA pain that requires treatment with potent opioids, systemic corticosteroids, intraarticular injections, duloxetine, or venlafaxine 4. Moderate to severe renal impairment 5. Pregnant or lactating women. 6. Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity 7. Suffering from any illness which will interfere with present study as decided by clinical investigator 8. History of hypersensitivity to any of the test products. 9. Any condition decided as unfit for study by Clinical investigator

Design outcomes

Primary

Measure	Time frame
1.Change in knee pain intensity measured by Pain VAS Scale(0 100 mm) 2. Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. 3. Changes in following laboratory parameter(s): Hs C Reactive Protein ESR FBR 4. Change in the WOMAC Physical Function Subscale. 5. Change in Patients Global Assessment of Osteoarthritis. 6. Change in the WOMAC Stiffness Subscale. 7. Changes in Quality of life Questionnaires (Short Form Health 12 or 36).Timepoint: 4 weeks, 8 weeks and 12 weeks	—

Measure

Time frame

1.Change in knee pain intensity measured by Pain VAS Scale(0 100 mm) 2. Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale. 3. Changes in following laboratory parameter(s): Hs C Reactive Protein ESR FBR 4. Change in the WOMAC Physical Function Subscale. 5. Change in Patients Global Assessment of Osteoarthritis. 6. Change in the WOMAC Stiffness Subscale. 7. Changes in Quality of life Questionnaires (Short Form Health 12 or 36).Timepoint: 4 weeks, 8 weeks and 12 weeks

—

Secondary

Measure	Time frame
To demonstrate safety and tolerability of study product by Clinical monitoring of adverse eventsTimepoint: 4 weeks, 8 weeks and 12 weeks	—

Countries

India

Contacts

Public ContactDr Ramesh Kannan

KI3, CRO

srkguruvarshan@gmail.com7708925866

Outcome results

None listed

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