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Clinical trial of Spinach and its formulation in knee osteoarthritis

Evaluation of the efficacy and safety of Spinacia oleracea extract tablets and formulation of Spinacia oleracea and Boswellia serrata extract tablets in knee osteoarthritis, Randomized placebo controlled clinical trial - SPINOA

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/015024
Enrollment
120
Registered
2018-07-24
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- Knee osteoarthritis

Interventions

Intervention1: Spinacia oleracea extract tablets (Spinasia): Spinacia oleracea extract 500mg tablets. one tablet twice a day for the period of three months. Intervention2: Formulation of Spinacia oler

Sponsors

Pharmanza Herbal Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American College of Rheumatology (ACR)criteria Knee Pain At least 1 of 3 A. Age >50 yrs B. Stiffness C. Crepitus 2. Osteophytes 3. 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 of Herbal formulations on clinical signs and symptoms in patients suffering from knee osteoarthritis assesses by WOMAC Score, Visual Analogue Scale (VAS).Timepoint: Day0, Day30, Day60 and Day90.

Secondary

MeasureTime frame
Effect of Herbal formulations on regenerative and degenerative biomarkers in patients suffering from knee osteoarthritisTimepoint: Day0, Day60 and Day90.

Countries

India

Contacts

Public ContactAmol Deshmukh

PHARMANZA HERBAL PVT LTD

rd@pharmanzaherbals.com9898652936

Outcome results

None listed

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