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St. John's Wort Oil on Osteoarthritis

T

TC Erciyes University

Status

Completed

Conditions

Pain
Osteoarthritis, Knee

Treatments

Other: locally applied to the skin

Study type

Interventional

Funder types

Other

Identifiers

NCT05663996
TDK-2017-7629

Details and patient eligibility

About

This study investigated the effect of St. John's Wort oil on pain intensity and physical functions in people with knee osteoarthritis. This study adopted a randomized, placebo-controlled, and qualitative mixed design. The sample consisted of 60 patients randomized into intervention (n=30) and placebo control (n=30) groups. The experimental group participants were treated with St. John's Wort oil three times a week for three weeks, while the placebo control group participants were treated with olive oil three times a week for three weeks. Quantitative data were collected using a patient identification form, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analogue Scale (VAS). Qualitative data were collected through semi-structured interviews. .

Full description

This study adopted a randomized, placebo-controlled, and qualitative mixed design. Qualitative data were collected using a semi-structured interview questionnaire.

The study was conducted in the physical therapy and rehabilitation outpatient clinic of a public hospital in Türkiye. The study population consisted of all patients admitted to the outpatient clinic for osteoarthritis-related pain. The data collection process continued from December 2017 to August 2018 and was reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. A pilot study was conducted with five patients before data collection.

Patients diagnosed with osteoarthritis by a physical therapy and rehabilitation specialist according to ACR criteria were randomized into the study by the University Biostatistics Unit. The initial sample consisted of 72 patients divided into intervention (n=36; St. John's wort oil) and placebo control (n=36; olive oil) groups. However, six experimental group participants were excluded because they either could not be contacted on the phone during the follow-ups (n=4) or stated that they would be out of town for a long time (n=2). Six control group participants were also excluded because they either could not be contacted on the phone during the follow-ups (n=3), did not want to keep up with the intervention (n=1), or wanted to withdraw from the study (n=2). Therefore, the final sample consisted of 30 experimental and 30 control group participants.

Enrollment

60 patients

Sex

All

Ages

35+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • being literate,
  • planning no pregnancy during the study,
  • not being pregnant,
  • having been diagnosed with knee osteoarthritis according to ACR (American College of Rheumatology),
  • having had knee pain for the past month,
  • needing analgesics for more than 15 days in a month,
  • having osteoarthritis-related knee pain despite routine treatment with analgesics,
  • having a VAS score of ≥ 4 on one knee,
  • speaking Turkish,
  • having no communication problems, and
  • volunteering

Exclusion criteria

  • Pregnant,
  • Having a physical disability in the area where the application will be made,
  • Having any skin disease in the area to be treated,
  • Having large scar tissue in the area to be treated,
  • Having a history of physical trauma in the last three months in the area to be treated,
  • Having any peripheral vascular disease in the area to be treated,
  • Having inflammatory joint disease,
  • Having a history of rheumatoid arthritis and fibromyalgia,
  • Using any complementary and integrative (integrated) health application in the last three months,
  • Those who have undergone intra-articular treatment in the last three months,
  • Receiving pain blocking treatment in the last year,
  • Receiving physical therapy in the last three months and during the application,
  • Patients with 2 or more pain in the other knee according to the VAS scale were not included in the study.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

St. John's Wort oil
Experimental group
Description:
Experimental group participants were treated with St. John's Wort oil.
Treatment:
Other: locally applied to the skin
Other: locally applied to the skin
Olive Oil
Placebo Comparator group
Description:
Control group participants were treated with olive oil.
Treatment:
Other: locally applied to the skin
Other: locally applied to the skin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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