Clinical trial of Spinach and its formulation in knee osteoarthritis

Phase 2

• Conditions: Health Condition 1: null- Knee osteoarthritis

• Registration Number: CTRI/2018/07/015024
• Lead Sponsor: Pharmanza Herbal Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. American College of Rheumatology (ACR)criteria

Knee Pain

At least 1 of 3

A. Age >50 yrs

B. Stiffness < 30 mins

C. Crepitus

2. Osteophytes

3. Patient willing to comply with study procedures and requirements

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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