NCT03658369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

September 1, 2018

Last Update Submit

September 9, 2019

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lanconone®

ACTIVE COMPARATOR

Lanconone®: 2 Capsules once a day after breakfast

Dietary Supplement: Lanconone®

Methyl Crystalline Cellulose

PLACEBO COMPARATOR

2 Capsules once a day after breakfast

Dietary Supplement: Methyl crystalline cellulose

Interventions

Lanconone®DIETARY_SUPPLEMENT

2 capsules

Lanconone®
Methyl crystalline celluloseDIETARY_SUPPLEMENT

2 Capsules

Methyl Crystalline Cellulose

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ayush Nursing Home

Mumbai, Maharashtra, 400067, India

Location

Dinanath Nursing Home

Mumbai, Maharashtra, 400067, India

Location

K.K Medical Centre

Mumbai, Maharashtra, 400068, India

Location

Siddhant Clinic

Mumbai, Maharashtra, 400076, India

Location

Study Officials

  • Shalini Srivastava, M.D.

    Vedic Lifesciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2018

First Posted

September 5, 2018

Study Start

August 16, 2018

Primary Completion

January 9, 2019

Study Completion

May 15, 2019

Last Updated

September 10, 2019

Record last verified: 2018-09

Locations

IN(4)