Back to resultsEffect of LANCONONE in Weight-bearing Joint Pain
Primary Purpose
Osteo Arthritis Knee
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Lanconone®
Methyl crystalline cellulose
Sponsored by
About this trial
This is an interventional supportive care trial for Osteo Arthritis Knee
Eligibility Criteria
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.
Sites / Locations
- Ayush Nursing Home
- Dinanath Nursing Home
- K.K Medical Centre
- Siddhant Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lanconone®
Methyl Crystalline Cellulose
Arm Description
Lanconone®: 2 Capsules once a day after breakfast
2 Capsules once a day after breakfast
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03658369
First Posted
September 1, 2018
Last Updated
September 9, 2019
Sponsor
Vedic Lifesciences Pvt. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03658369
Brief Title
Effect of LANCONONE in Weight-bearing Joint Pain
Official Title
To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
January 9, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lanconone®
Arm Type
Active Comparator
Arm Description
Lanconone®: 2 Capsules once a day after breakfast
Arm Title
Methyl Crystalline Cellulose
Arm Type
Placebo Comparator
Arm Description
2 Capsules once a day after breakfast
Intervention Type
Dietary Supplement
Intervention Name(s)
Lanconone®
Intervention Description
2 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Methyl crystalline cellulose
Intervention Description
2 Capsules
Primary Outcome Measure Information:
Title
WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score
Description
Change in pain score.The score ranges from 0-5, wherein 0 indicates no pain and 5 indicates extreme pain.
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalini Srivastava, M.D.
Organizational Affiliation
Vedic Lifesciences
Official's Role
Study Director
Facility Information:
Facility Name
Ayush Nursing Home
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400067
Country
India
Facility Name
Dinanath Nursing Home
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400067
Country
India
Facility Name
K.K Medical Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400068
Country
India
Facility Name
Siddhant Clinic
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400076
Country
India
12. IPD Sharing Statement
Learn more about this trial
Effect of LANCONONE in Weight-bearing Joint Pain
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