NCT02569359

Brief Summary

Recurrent hemarthrosis results in synovitis and destructive arthropathy in hemophilic patients. Prophylactic replacement, physical therapy, cyclooxygenase-2 (COX-2) inhibitors, corticosteroids, and radionucleotide synovectomy are some of the typical modalities used in the managements hemophilic synovitis and arthropathy. In clinical practice, the choice of non-steroidal anti-inflammatory drugs (NSAIDs) also needs to take into consideration the risk for cardiovascular events and should be used at the lowest effective dose and for the shortest duration.This study will investigate the safety and efficacy of Shea nut oil for the treatment of hemophilic arthropathy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

October 1, 2015

Last Update Submit

April 1, 2021

Conditions

HemophiliaHemophilic Arthropathy

Outcome Measures

Primary Outcomes (1)

  • Pain (visual analogue scale) and Change from Baseline Pain at 1 &3 months

    The pain intensity will be evaluated subjectively on a visual analogue scale (0-100mm).

    baseline, 1 month, 3 months

Secondary Outcomes (6)

  • CTX-II (ng/mmol creatinine) and Change from Baseline at 1 & 3 months

    baseline, 1 month, 3 months

  • Tumor Necrosis Factor alpha (pg/mL) and Change from Baseline at 1 & 3 months

    baseline, 1 month, 3 months

  • Ultrasonographic synovial thickness (mm) and Change from Baseline at 1 &3 months

    baseline, 1 month, 3 months

  • Synovial hyperemia (score) and Change from Baseline at 1& 3 months

    baseline, 1 month, 3 months

  • Short Form -36 score and Change from Baseline at 1 & 3 months

    baseline, 1 month, 3 months

  • +1 more secondary outcomes

Study Arms (2)

Shea nut oil

EXPERIMENTAL

100% shea nut oil extract with 75% triterpene esters. Daily dosage is three 750 mg soft gel capsules (2250 mg/per day) taken in the morning for 3 months

Dietary Supplement: shea nut oil extract

Placebo

PLACEBO COMPARATOR

placebo which comprised 100% canola oil or starch mixed soybean oil

Other: Placebo

Interventions

shea nut oil extractDIETARY_SUPPLEMENT
Shea nut oil
PlaceboOTHER
Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20 years and above
  • hemophilia A or B patients who reported painful (VAS ≥ 3) hemophilic arthropathy in ankles, elbows or knees for at least 6 months.

You may not qualify if:

  • presence of joint infections
  • any surgery on the joint in preceding 6 months
  • intra-articular HA injection within the past 6 months
  • history of rheumatoid arthritis,
  • gouty arthropathy
  • presence of neoplasm,
  • allergy to shea nut oil production
  • use of corticosteroids within 3 weeks prior to baseline and throughout the study
  • use of anti-inflammatory agents 3 weeks prior to baseline and for the duration of the study,
  • history of trauma associated with the signal joint,
  • liver function tests greater than twice the upper limit of normal at baseline
  • history of alcohol or substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hemophilia care and research center

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Tsung-Ying Li

    Hemophilia care and research center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 6, 2015

Study Start

April 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations

TW(1)