Effect of LANCONONE in Weight-bearing Joint Pain

NCT ID: NCT03658369

Last Updated: 2019-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-16

Study Completion Date

2019-05-15

Brief Summary

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

Detailed Description

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Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lanconone®

Lanconone®: 2 Capsules once a day after breakfast

Group Type ACTIVE_COMPARATOR

Lanconone®

Intervention Type DIETARY_SUPPLEMENT

2 capsules

Methyl Crystalline Cellulose

2 Capsules once a day after breakfast

Group Type PLACEBO_COMPARATOR

Methyl crystalline cellulose

Intervention Type DIETARY_SUPPLEMENT

2 Capsules

Interventions

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Lanconone®

2 capsules

Intervention Type DIETARY_SUPPLEMENT

Methyl crystalline cellulose

2 Capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vedic Lifesciences Pvt. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shalini Srivastava, M.D.

Role: STUDY_DIRECTOR

Vedic Lifesciences

Locations

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Ayush Nursing Home

Mumbai, Maharashtra, India

Site Status

Dinanath Nursing Home

Mumbai, Maharashtra, India

Site Status

K.K Medical Centre

Mumbai, Maharashtra, India

Site Status

Siddhant Clinic

Mumbai, Maharashtra, India

Site Status

Countries

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India

Other Identifiers

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EB/180601/LANCONONE/PAIN

Identifier Type: -

Identifier Source: org_study_id

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