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NCT03658369 Clinical Trial

Effect of LANCONONE in Weight-bearing Joint Pain

Osteo Arthritis Knee Clinical Trial

Official title:
To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03658369
Other study ID # EB/180601/LANCONONE/PAIN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 16, 2018
Est. completion date May 15, 2019

Study information
Verified date September 2018
Source Vedic Lifesciences Pvt. Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date May 15, 2019
Est. primary completion date January 9, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria:

1. BMI = 25 and = 29.9 kg/m2.

2. 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.

3. Post-menopausal females (LMP at least 12 months prior to the screening).

Exclusion Criteria:

1. History of osteoarthritis for more than 3 years.

2. Systolic Blood Pressure =140 mm Hg and Diastolic Blood Pressure = 90 mm Hg

3. FBS>140 mg/dl.

4. Smokers or chronic alcoholics.

5. Participants planning to travel in the next 56 days or engage in any non-routine activity that is likely to strain the knees.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Lanconone®
2 capsules
• Methyl crystalline cellulose
2 Capsules

Locations
Country Name City State
India Ayush Nursing Home Mumbai Maharashtra
India Dinanath Nursing Home Mumbai Maharashtra
India K.K Medical Centre Mumbai Maharashtra
India Siddhant Clinic Mumbai Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score Change in pain score.The score ranges from 0-5, wherein 0 indicates no pain and 5 indicates extreme pain. 56 days
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