A clinical study of LCOX to check its efficacy and tolerability in osteoarthritis patients of Knee.

Phase 2

Recruiting

• Conditions: osteoarthritis of knee joints

• Registration Number: CTRI/2015/06/005864
• Lead Sponsor: Pharmanza Herbal Pvt Ltd

Brief Summary

This study is a randomized double blind parallel group placebo controlled study, this study is aimed to check efficacy and tolerability of Lcox tablets in knee osteoarthritis patients of either sexes.  Lcox is FDA approved polyherbal formulation of Pharmanza Herbal Pvt. Ltd. Each tablet of Lcox contains

1. Shallaki (BoswelliaSerrata) 300mg

2. Ashwagandha (WithaniaSomnifera) 100mg

3. Hadjod (Cissusquadrangularis) 100mgfrom

2 Lcox tablets twice a day will be given to patient in trial group of fifty patients. 2 placebo tablets twice a day will be given to patients in placebo group. treatment will be continue for 2 months for each patient and monthly assessment will be done using WOMAC scale. Data will be recorded and will be used to publish in peer reviewed journals.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-06
• Last Update Posted: 2016-12-24

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Clinico-radiologically diagnosed patients of OA knee b.
• Patients willing to participate and give signed informed consent c.
• Either gender d.
• Age >40 years.

Exclusion Criteria

• History of peptic ulcer, acid peptic disease or any other concurrent illness b.
• End organ damage.
• RFT, LFT will be conducted pre and post session.
• Chronic smoker/ alcoholic e.
• History of allergy against herbal products or NSAIDs f.
• Subjects who cannot be relied upon to comply with instructions g.
• Pregnant or breast feeding women h.
• Gouty Arthritis, Rheumatoid Arthritis, Psoriatic arthritis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
difference between WOMAC score in two groups	at baseline after one month after second month

Secondary Outcome Measures

Name	Time	Method
decrease in level of CTX2 in urine samples of two groups.	at baseline and after second month

Trial Locations

Locations (1)

Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik; 🇮🇳 Nashik, MAHARASHTRA, India

Ayurved Sanshodhan Vibhag, Ayurved Seva Sangh, Nashik

🇮🇳Nashik, MAHARASHTRA, India

Dr Pankaj Prabhakar Dixit

Principal investigator

sanshodhanayusevansk@gmail.com