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Effect of Topical 1% Hedera helix L. Extract gel in Treatment of Primary Knee Osteoarthritis

Comparing the effect of Topical 1% Hedera helix L. Extract gel and 1% Diclofenac gel in the Treatment of Primary Knee Osteoarthritis Patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110514006480N14
Enrollment
150
Registered
2018-06-08
Start date
2018-06-05
Completion date
Unknown
Last updated
2018-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis. Arthrosis

Interventions

Intervention 1: Intervention group 1: topical use of 1% diclofenac gel (the tubes of 60 gram)
three times a day for six weeks and each time applied the gel over the site of interest for 3 to 5 minutes. Intervention 2: Intervention group 2: topical use of 1% H. helix extract 1% gel (the tubes
three times a day for six weeks and each time applied the gel over the site of interest for 3 to 5 minutes. Intervention 3: Control group: topical use of placebo (the tubes of 60 gram)
three times a day for six weeks and each time applied the gel over the site of interest for 3 to 5 minutes.

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: Primary osteoarthritis in at least one knee Having pain at least 2 weeks before treatment

Exclusion criteria

Exclusion criteria: Secondary osteoarthritis Active liver or kidney disease, peptic ulcer, diabetes, thyroid and parathyroid diseases, and coagulation disorders Consumed anticoagulant drugs History of ischemic or hemorrhagic stroke or deep vein thrombosis, history of local fractures, and deformities leading to osteoarthritis and articular diseases Allergy to any anti-inflammatory drug Alcohol abuse, drug abuse Used Corticosteroids of any type and other topical drugs at the site where the gel was applied, orally used other analgesics and other effective compounds for the treatment of osteoarthritis up to 10 days before beginning of the study Pregnancy

Design outcomes

Primary

MeasureTime frame
Severity of knee pain. Timepoint: Before as well as one, two, three, and six weeks after intervention. Method of measurement: Visual analog scale.;Morning stiffness. Timepoint: Before as well as one, two, three, and six weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.;Daytime stiffness. Timepoint: Before as well as one, two, three, and six weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.;Physical function. Timepoint: Before as well as one, two, three, and six weeks after intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMorteza Dehghani

Shahre-kord University of Medical Sciences

dehghan_mortaza@yahoo.com+98 913 183 2044

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026