An interventional study of Lanconone and Placebo in Knee Osteoarthritis, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed at 3 sites in India. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-04-30.
Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Treatment
Among 24 studies in Osteoarthritis, Knee with a site in India — 1 open to participants now, 1 under way, none of them phase 3. Osteoarthritis, Knee · India.
Among the 24 studies in Osteoarthritis, Knee with a site in India, this one is the 17th largest by enrollment of the 22 interventional ones that give a count, is one of 4 that started in 2017, is one of 13 with no phase, and was the 8th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.
Browse Osteoarthritis, Knee studies →1 of the 24 studies in Osteoarthritis, Knee with a site in India is open now. Recruiting first, the newest first:
All India Institute of Medical Sciences, Jodhpur · Sites in India
Ages 30–65
A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 40 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 2 · Phase 4 4
First in 2007; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 73 is close to the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Median enrollment 104 across the 22 interventional studies, 578 across the 2 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.
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13 of 24 have an industry lead sponsor. The 10 most frequent:
Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 72 studies on the registry; 8 are open to participants now.
Vedic Lifesciences Pvt. Ltd. has 9 studies filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 24 studies in Osteoarthritis, Knee with a site in India, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The current study is designed to assess the pain relieving effect of 4-weeks ingestion of this commercialized dietary supplement (Lanconone®, Enovate Biolife, LLC, 1000 mg twice per day) in mild to moderate OA subjects. Also, the current study intends to assess the safety and efficacy of long term administration of Lanconone in larger sample size as compared to the earlier studies.15,16 The study also intends to analyse the effect on joint stiffness and function by means of self-reported WOMAC \& Lequesne questionnaire.The effect of IP on clinically proven biomarker, hs-CRP will be analyzed in comparison with placebo.
This study has been planned to evaluate the efficacy of Lanconone® in enhancing the overall joint health in the population of ≥ 40 years of age during the daily life activities by the reduction of the joint pain and discomfort. Assessment of pain is the primary objective which will be done by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). It is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the severity of osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. The early onset of action (3 days after commencement of the IP administration) for pain relief which was not captured in the past studies, will be captured in the current study by the telephonic assessment of the study subjects. Lequesne et al developed an index of severity for osteoarthritis for the knee which can be used to assess the effectiveness of therapeutic interventions. Unlike the earlier studies, we will use the Lequesne Functional Index (LFI) to assess the extent of joint health degeneration. In relation to OA, elevated levels of hs-CRP have been correlated with symptoms of joint pain and stiffness. Hence, we decided to analyze the hs-crp levels as one of the secondary objectives. Also, the rescue medication consumption has been limited to lower per day consumption compared to earlier studies to avoid the placebo effect influence on the study results. The efficacy of the IP in sustaining the pain relieving effect will be analyzed on day 35, i.e. one week after the end of the treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo
Other: Placebo
Lanconone(R)
Dietary Supplement: Lanconone
. Lanconone® is a joint pain supplement containing natural herbs such as Shyonak, Ashwagandha, Shunthi, Guggul, Chopchini, Rasna and Shallaki in therapeutic quantities and documented in the ancient scriptures as pain relievers.
Microcrystalline cellulose
WOMAC pain score.
• Change in terms of percentage reduction of joint pain from baseline to Day 28 during daily life activities assessed by WOMAC pain score.
Time frame: 28 days
WOMAC stiffness score
Change in terms of percentage reduction of joint pain from baseline to Day 28 joint stiffness as assessed by WOMAC stiffness score.
Time frame: 28 days
WOMAC physical performance score.
Change in terms of percentage reduction of joint pain from baseline to Day 28 in physical performance during daily life activities as assessed by WOMAC physical performance score.
Time frame: 28 days
Lequesne Functional Index
% reduction in joint degradation process as from baseline to Day 28 as assessed by Lequesne Functional Index
Time frame: 28 days
Serum hs-CRP levels.
% reduction in joint pain marker from baseline to Day 28 as assessed by serum hs-CRP levels.
Time frame: 28 days
BMI
% change in joint degradation related risk factor from baseline to Day 28 as assessed by BMI.
Time frame: 28 days
% responders
Comparison of uniformity of positive pain relieving individual response as assessed by % responders with ≥ 17% reduction in WOMAC pain score at Day 28.
Time frame: 28 days
Rescue medication consumption
Comparison of alternate analgesic therapy requirement as assessed by number of rescue medication consumption during the study.
Time frame: 28 days
Sustained effect
• To assess the sustained drug free period as assessed by WOMAC pain score joint pain at Day 35 as compared to Day 28.
Time frame: 35 days
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Jan 2018, 5 months.
Of 140 industry-sponsored interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 5 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Vedic Lifesciences Pvt. Ltd. →