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A clinical trial to find out effectiveness of Spinach (Spinacia oleracea) extract Capsules in knee osteoarthritis

Evaluation of the efficacy and safety of Spinacia oleracea extract Capsules in knee osteoarthritis:A randomized double-blind controlled clinical trial - SOKO

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017689
Enrollment
80
Registered
2019-02-15
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: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Spinasia capsules: each capsule of spinasia contains spinacia oleracea extract 500mg. Dose- one capsule of spinasia. Frequency-two times in a day. Route of administration-orally with wa

Sponsors

Pharmanza Herbal Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Fulfilling osteoarthritis ACR criteria 1. Knee Pain 2. At least 1 of these 3 (Age >50 yrs, Stiffness 3. Osteophytes AND Patient willing to comply with study procedures and requirements

Exclusion criteria

Exclusion criteria: 1. Patients with congenital arthropathy, rheumatoid arthritis, active gout, other type of arthritis with/without inflammation e.g. septic , fibromyalgia or collagen vascular disease 2. Patients with known history of coagulopathies 3. Osteoarthritis of any other joint except knee 4. Patients with history of major trauma or surgery in the knee joint 5. Patients with uncontrolled diabetes and hypertension 6. Body mass index (BMI) >40 kg/m2. 7. Patients with any severe cardiac, renal and hepatic disease 8. Pregnant and lactating women 9. Patients who participated in any clinical trial within 30 days before enrolment into the study

Design outcomes

Primary

MeasureTime frame
Effect on clinical signs and symptoms in knee osteoarthritis patients Effect on inflammatory and degenerative biomarkers in knee osteoarthritis patients Timepoint: Day 0, 30, 60, 90, 120, 180, 240, 300 and 360

Secondary

MeasureTime frame
Effect on inflammatory and degenerative biomarkers in knee osteoarthritis patients Timepoint: Day 0, Day 60, Day 180 and Day 360

Countries

India

Contacts

Public ContactDr Saurabh Deshmukh

Mahatma Gandhi Ayurveda college hospital and Research centre

ayurrulz@gmail.com9404337799

Outcome results

None listed

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