Osteo Arthritis KneeNCT03658369
Effect of LANCONONE in Weight-bearing Joint Pain
A study testing Lanconone® and Methyl crystalline cellulose in people with Osteo Arthritis Knee, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Lanconone® and Methyl crystalline cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 4 sitesIndia
- Study dates
- 16 Aug 2018to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
India4 sites
Ayush Nursing Home
Mumbai, Maharashtra, 400067
Dinanath Nursing Home
Mumbai, Maharashtra, 400067
K.K Medical Centre
Mumbai, Maharashtra, 400068
Siddhant Clinic
Mumbai, Maharashtra, 400076
About this study
Official title: 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.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Lanconone®, Methyl crystalline cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanconone®Dietary supplement
2 capsules
Methyl crystalline celluloseDietary supplement
2 Capsules
| Study group | Role | What they receive |
|---|---|---|
| Lanconone® | Active comparator | Lanconone®: 2 Capsules once a day after breakfast Receives: Dietary Supplement: Lanconone® |
| Methyl Crystalline Cellulose | Placebo comparator | 2 Capsules once a day after breakfast Receives: Dietary Supplement: Methyl crystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start16 Aug 2018
- Primary completion9 Jan 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shalini Srivastava, M.D., Study director, Vedic Lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658369
- Sponsor's protocol ID
- EB/180601/LANCONONE/PAIN
- Status last verified
- Sep 2018
- First submitted
- 1 Sep 2018
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Lanconone® (E-OA-07) Efficacy in Weight-bearing Joint Pain
- ClinicalTrials.gov ID
- NCT03658369
- Acronym / sponsor ID
- EB/180601/LANCONONE/PAIN
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study has been designed to primarily assess the effect of Lanconone® in comparison to placebo on pain in weight bearing joints.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lanconone® | Active comparator | Dietary Supplement: Lanconone®Lanconone®: 2 Capsules once a day after breakfast |
| Methyl Crystalline Cellulose | Placebo comparator | Dietary Supplement: Methyl crystalline cellulose2 Capsules once a day after breakfast |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanconone®2 capsules | Dietary supplement | Lanconone® |
| Methyl crystalline cellulose2 Capsules | Dietary supplement | Methyl Crystalline Cellulose |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
Related trials for Osteo Arthritis Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Srivastava, M.D. study director
Vedic Lifesciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lanconone® and Methyl crystalline cellulose in people with Osteo Arthritis Knee, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (Western Ontario and McMaster universities Osteoarthritis Index) pain score (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.