NCT04506411

Brief Summary

The objective of the study is to test the capacity of a 12-weeks Turmipure GOLD® supplementation to reduce joint discomfort.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
2 countries

8 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

First Submitted

Initial submission to the registry

July 29, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 24, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

2.4 years

First QC Date

July 29, 2020

Last Update Submit

May 2, 2023

Conditions

Knee DiscomfortJoint Pain

Keywords

MobilityJoint functionTurmericCurcuminoids

Outcome Measures

Primary Outcomes (1)

  • Change in WOMAC™ Pain

    Knee joint pain discomfort assessed with the validated Western Ontario and McMaster University questionnaire (WOMAC) using its visual analogue scale version (VAS). The WOMAC VA 3.1 Pain subscore (WOMAC A) ranges from 0 to 100 mm (averaging five VAS 0-100 mm) with higher scores indicating more pain.

    12-weeks

Secondary Outcomes (14)

  • Change in WOMAC™ Stiffness

    12-weeks

  • Change in WOMAC™ Physical function

    12-weeks

  • Change in WOMAC™ Global Index

    12-weeks

  • Pain intensity at rest

    12-weeks

  • Pain intensity while walking

    12-weeks

  • +9 more secondary outcomes

Study Arms (3)

TPG

EXPERIMENTAL

59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive Turmipure GOLD® product during 12 weeks

Dietary Supplement: Turmipure GOLD®

STE

ACTIVE COMPARATOR

59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive standard turmeric extract 95% curcuminoids (STE) product during 12 weeks

Dietary Supplement: Turmeric rhizome PE 95% curcuminoids

Control

PLACEBO COMPARATOR

59 participants who meet the eligibility criteria will be randomized under experimental arm and will receive placebo (maltodextrin) product during 12 weeks

Dietary Supplement: Placebo

Interventions

Turmipure GOLD®DIETARY_SUPPLEMENT

TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed

TPG
Turmeric rhizome PE 95% curcuminoidsDIETARY_SUPPLEMENT

STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed

STE
PlaceboDIETARY_SUPPLEMENT

Placebo: Maltodextrin - 4 capsules once daily- as prescribed

Control

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consent to the study and to comply with study product
  • Who have a BMI between 18 and 32 kg/m²
  • Who has mild to moderate knee pain for at least 3 months before enrollment (VAS between 40 to 70 on 100mm scale after respecting a washout period depending on the half-life of the excluded medications)
  • Who has radiographic evidence of Kellgren-Lawrence score 0, 1, 2 and 3 in the tibio-femoral compartment of the target knee
  • Who is able to perform the physical performance-based tests and understands all questions from the WOMAC questionnaire
  • Who is willing to refrain from taking any pain reliever (OTC or prescription) and other pharmacological, nutritional agent (e.g. glucosamine), device or therapy (e.g. acupuncture) which may influence the study outcome during the entire trial (other than determined authorized rescue medication)
  • Who is willing to not change dietary habits, level of physical activity (including any heavy physical work with high loading of the knee joints) and body weight

You may not qualify if:

  • Subjects with any clinically significant levels of the safety parameters at screening
  • Pregnant or lactating females, or wishing to become pregnant during the study
  • Subject with joint pain related to some predisposing conditions that have adversely altered the joint tissues often due to a specific cause
  • Subject with Kellgren-Lawrence grade 4 in the tibio-femoral compartment of the target knee
  • Who has clinically apparent tense effusion of the target knee or other joint
  • Who has/had viscosupplementation in any joint including the target knee or other joint within 6 months prior to screening
  • Who has symptomatic osteoarthritis of the contralateral knee that is not responsive to paracetamol and requires other therapy
  • Who is taking any treatment/supplementation which may interfere with study conduct and interpretation of study results (4-weeks washout, e.g. glucosamine, chondroitin, corticosteroids) except calcium and vitamin D supplements
  • Subject has a history of drug and / or alcohol abuse at the time of enrollment
  • Change of dietary habit within the preceding month
  • Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumor of intestine or colon and significant systemic disease
  • Subject currently involved in any other clinical trial or having participated in a trial within the preceding 90 days
  • Subject with known allergy to components of the test product
  • Subject has any concurrent medical or psychiatric condition that, in the opinion of the Investigator, would compromise his/her ability to comply with the study requirements
  • History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Poliklinika Aviva

Zagreb, Croatia

Location

Poliklinika Idassa

Zagreb, Croatia

Location

Ortopedska bolnišnica Valdoltra

Ankaran, Slovenia

Location

Splošna bolnišnica Jesenice, Oddelek za ortopedijo

Jesenice, Slovenia

Location

Bisturmed, d.o.o., Ortopedija in fizioterapija

Koper, Slovenia

Location

Poliklinika Nobilis, d.o.o., enota LJ, Ortopedska ambulanta

Ljubljana, Slovenia

Location

Medicinsko termalni center Fontana, d.o.o., Ortopedska ambulanta

Maribor, Slovenia

Location

Univerzitetni klinični center Maribor, Oddelek za ortopedijo

Maribor, Slovenia

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Diarylheptanoids

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Matija Tomšič, Prof., MD

    Univerzitetni klinični center Ljubljana, Klinični oddelek za revmatologijo, Ljubljana, Slovenia

    STUDY CHAIR

  • Samo K Fokter, MD

    Univerzitetni klinični center Maribor, Oddelek za ortopedijo

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 10, 2020

Study Start

September 24, 2020

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

SL(6)CR(2)