Clinical Study to evaluate the Efficacy and Safety of EASY CLIMB CAPSULES in Patients with Painful knee Osteoarthritis’

Completed

• Conditions: Osteoarthritis,

• Registration Number: CTRI/2014/11/005205
• Lead Sponsor: Natsyn Catalysts

Brief Summary

| | |

| --- | --- |

|ARandomized, Double Blind, Placebo controlled, clinical  Study to evaluate the Efficacy and Safety of **EASY CLIMB** **CAPSULES** inPatientswithPainful knee Osteoarthritis.

| |

| --- |

|**Primary objectives:** To show that the efficacy of **EASY CLIMB** **CAPSULES** inPatients withPainful Knee Osteoarthritis.

**Secondary objectives:**To evaluate the safety of **EASY CLIMB** **CAPSULES**inPatients withPainful Knee Osteoarthritis

**Primary outcomes**

- Patients Assessment of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale (VAS)]

- Change from Baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index-pain subscale score

- WOMAC Osteoarthritis Composite Index & QOL

- Changes in the arthritis impact measurement scale (AIMS 2)

- Change from Baseline in the CGI (Clinical Global Impression) scale score

- Changes in [Comprehensive Metabolic Panel (CMP)](http://labtestsonline.org/understanding/analytes/cmp), &Synovial Fluid analysis.

**Secondary outcomes**

- Safety assessed byAdverse Events

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-13
• Study Completion: 2015-11-05
• Last Update Posted: 2018-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• •Men and women with age of 40 – 65 with a diagnosis of arthritis.
• •Obtaining written Inform consent along with audio, video visual.
• •Patients with mild to moderate arthritis •Participants who are able to visit the medical institutions throughout the study period.

Exclusion Criteria

• •Patients with Uncontrolled hypertension or diabetes.
• •Patients with Hepatic or renal impairment •Patients with Current or expected use of anticoagulant •Candidates for imminent joint replacement •Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months •Participation within 30 days prior to screening in another investigational study •Conditions in the opinion of the investigator make the patient unsuitable to participate in the study.
• •Any contraindication to blood sampling.
• •HIV Positive serology •Pregnant (or) Lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Changes in the arthritis impact measurement scale (AIMS 2)	•Screening to EOT (Day 120)
•Patients Assessment of Osteoarthritis Pain by VAS [Osteoarthritis- Pain Visual analog scale (VAS)]	•Screening to EOT (Day 120)
•Change from Baseline in the WOMAC OA (Western Ontario and McMaster Universities Osteoarthritis) Index-pain subscale score	•Screening to EOT (Day 120)
•Change from Baseline in the CGI (Clinical Global Impression) scale score	•Screening to EOT (Day 120)
•WOMAC Osteoarthritis Composite Index & QOL	•Screening to EOT (Day 120)
•Changes in Comprehensive Metabolic Panel (CMP), &Synovial Fluid analysis.	•Screening to EOT (Day 120)

Secondary Outcome Measures

Name	Time	Method
Safety assessed by Adverse Events	Screening to EOT (Day 120)

Trial Locations

Locations (2)

Bangalore Diabetic Center; 🇮🇳 Bangalore, KARNATAKA, India

Sampoorn Health Care (Ayurveda Department,Clinical Division); 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Diabetic Center

🇮🇳Bangalore, KARNATAKA, India

Dr Rajanna Muniswamappa

Principal investigator

9880367101

dr.rajanna@gmail.com