- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03658369
Effect of LANCONONE in Weight-bearing Joint Pain
September 9, 2019 updated by: Vedic Lifesciences Pvt. Ltd.
To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain
The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400067
- Ayush Nursing Home
-
Mumbai, Maharashtra, India, 400067
- Dinanath Nursing Home
-
Mumbai, Maharashtra, India, 400068
- K.K Medical Centre
-
Mumbai, Maharashtra, India, 400076
- Siddhant Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI ≥ 25 and ≤ 29.9 kg/m2.
- With unilateral or bilateral OA of the knee for at least greater than 3 months, as presented by pain in the knee at least for last 3 months.
- Post-menopausal females (LMP at least 12 months prior to the screening).
Exclusion Criteria:
- History of osteoarthritis for more than 3 years.
- Systolic Blood Pressure ≥140 mm Hg and Diastolic Blood Pressure ≥ 90 mm Hg
- FBS>140 mg/dl.
- Smokers or chronic alcoholics.
- Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lanconone®
Lanconone®: 2 Capsules once a day after breakfast
|
2 capsules
|
Placebo Comparator: Methyl Crystalline Cellulose
2 Capsules once a day after breakfast
|
2 Capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score
Time Frame: 56 days
|
Change in pain score.The score ranges from 0-5, wherein 0 indicates no pain and 5 indicates extreme pain.
|
56 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2018
Primary Completion (Actual)
January 9, 2019
Study Completion (Actual)
May 15, 2019
Study Registration Dates
First Submitted
September 1, 2018
First Submitted That Met QC Criteria
September 1, 2018
First Posted (Actual)
September 5, 2018
Study Record Updates
Last Update Posted (Actual)
September 10, 2019
Last Update Submitted That Met QC Criteria
September 9, 2019
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EB/180601/LANCONONE/PAIN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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