A clinical trail to study the efficacy, safety and tolerability of E-OA-07 in Patients with Osteoarthritis of the Knee Joint

An exploratory, randomized, triple-blind, placebo controlled study to investigate the efficacy, safety and tolerability of E-OA-07 in Patients with Osteoarthritis of the Knee Joint

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000328

Enrollment

Registered

2010-02-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Osteoarthritis of the Knee joint

Interventions

Intervention1: E-OA-07: 2 tablets twice daily for 12 weeks Control Intervention1: Placebo ( Carboxy Methyl Cellulose): 2 tablets twice daily for 12 weeks

Eligibility

Inclusion criteria

Inclusion criteria: ? Ambulatory adult patients of either sex aged 20-65 years. ? Patients with moderate to severe Osteoarthritis of knee(s), (signal joint) which is clinically detected and/or diagnosed as per Radio logic examination and American Rheumatism Association (ARA) functional classification. Note - The primary knee joint under study will be nominated as the ?signal joint? while the other affected joint(s), if any, will be termed as ?non-signal joints?. ? ARA functional classes II and III. ? Kellgren Lawrence for Knee Osteoarthritis of Grade II, Grade III. ? Patient?s functional assessment of overall pain score should be ≥ 70 on a 100 mm Pain-Visual analog scale. ? Subjects willing to maintain physical activity levels. ? Subjects with Modified WOMAC score for the signal joint of 60 and above

Exclusion criteria

Exclusion criteria: ? Patients of any other arthritis other than Osteoarthritis. ? Patients with severe trauma to the knee joint. ? Arthroscopy of either knee in the past year. ? Administration of intra-articular steroids in the past 3 month or hyaluronic acid in the last 9 months. ? Patients has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication. ? Patients with DVT or pre-disposed to DVT as evidenced by a score of >0 using Wells criteria for DVT. ? Moderate to severe peripheral neuropathy or other neurological disorders ? Patients requiring immediate Surgery for knee. ? Pregnant / lactating women and women who are planning to get pregnant ? Known hypersensitivity or allergy to one or more of the herbal ingredients ? Recent (< 3 months) participation in a clinical trial ? Major chronic disease of liver, CVS or CNS ? A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms ? Subjects otherwise judged by the investigator to be inappropriate for inclusion in the study ? Patients unwilling to discontinue their current medication for OA. ? Patients with peptic ulcer disease, bleeding diathesis, coagulation disorders, on anti-coagulant therapy ? Patients scheduled for any surgery within 3 months of completing the study. ? Patients with serum cholesterol levels >280 mg% and serum triglyceride levels > 500 mg% ? Patients with serum uric acid levels >8.3 mg%

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of IP in reducing symptoms in osteoarthritis of the signal joint using Modified WOMAC questionnaire as compared to placeboTimepoint: Day -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84	—

Secondary

Measure	Time frame
1) To assess the efficacy of IP in reducing pain of signal and non-signal joint(s) using Pain-VAS as compared to placebo 2) To assess the efficacy of IP in reducing stiffness of signal and non-signal joint(s) using Stiffness ?VAS as compared to placebo 3) To assess the efficacy of IP in improving movement of signal and non-signal joint(s) using Movement ?VAS as compared to placebo 4) To assess the efficacy of IP by improvement in performance of a) timed up-and-go test, b) unilateral anterior reach test and c) medial step-down test as compared to placebo 5) To assess the efficacy of IP in improving signal joint mobility as measured by goniometry as compared to placebo 6) To assess the safety and tolerability of the IP 7) To assess the efficacy of the IP in reducing the use of rescue medication as compared to placebo 8) To assess the carryover efficacy of the IP as measured by number of days for which subject stays medication-free after stopping the IP as compared to placebo Timepoint: 1) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84 2) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84 3) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84 4) Day 1, Day 42 & Day 84 5) Goniometry 6) Day 42 & Day 84 7) Day 100 & Day 130 8) Day 130	—

Measure

Time frame

1) To assess the efficacy of IP in reducing pain of signal and non-signal joint(s) using Pain-VAS as compared to placebo 2) To assess the efficacy of IP in reducing stiffness of signal and non-signal joint(s) using Stiffness ?VAS as compared to placebo 3) To assess the efficacy of IP in improving movement of signal and non-signal joint(s) using Movement ?VAS as compared to placebo 4) To assess the efficacy of IP by improvement in performance of a) timed up-and-go test, b) unilateral anterior reach test and c) medial step-down test as compared to placebo 5) To assess the efficacy of IP in improving signal joint mobility as measured by goniometry as compared to placebo 6) To assess the safety and tolerability of the IP 7) To assess the efficacy of the IP in reducing the use of rescue medication as compared to placebo 8) To assess the carryover efficacy of the IP as measured by number of days for which subject stays medication-free after stopping the IP as compared to placebo Timepoint: 1) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84 2) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84 3) Signal Joints - Dy -7/-15, Day 1, Day 21, Day 42, Day 63, Day 84. Non - Signal Joints - Day 1 & Day 84 4) Day 1, Day 42 & Day 84 5) Goniometry 6) Day 42 & Day 84 7) Day 100 & Day 130 8) Day 130

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Countries

India

Contacts

Public ContactSeema Damakale

None

medical@vediclifesciences.com022-42172306

Outcome results

None listed

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