Impact of Sheep Ghee on Knee Osteoarthritis in Older Adults

The Effects of Sheep Ghee on Pain, Stiffness, Physical Function, and Range of Motion of the Knee Joint in Older People With Osteoarthritis of the Knee

• The goal of this clinical trial is to learn if treatment with sheep ghee can improve stiffness, pain, range of motion, and physical function in adults with knee joint issues.

• The main questions it aims to answer are:

  i. Does sheep ghee treatment reduce knee stiffness? ii. Does it decrease knee pain? iii. Does it improve range of motion? iv. Does it enhance physical function?

• Researchers will compare the group receiving sheep ghee treatment to a control group to see if there are significant improvements in knee joint health. Additionally, the placebo group receiving vaseline will be compared to the intervention group.

• Participants will:

  • Receive a sheep ghee and vaseline treatment for their knee joint.
  • Complete assessments of their stiffness, pain, range of motion, and physical function.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Other: Sheep ghee

Detailed Description

Overview:

This clinical trial aims to investigate the therapeutic potential of sheep ghee in alleviating knee joint problems among adults. Given the rising interest in alternative treatments for musculoskeletal conditions, this study focuses on whether sheep ghee can effectively improve knee stiffness, reduce pain, enhance the range of motion, and improve overall physical function in participants suffering from knee joint issues.

Objectives:

The primary objective of this clinical trial is to assess the following key questions regarding the effectiveness of sheep ghee treatment:

Does sheep ghee treatment reduce knee stiffness?

Understanding the impact of sheep ghee on the rigidity of knee joints, which may limit mobility and daily activities.

Does it decrease knee pain?

Evaluating pain levels before and after treatment to determine the analgesic properties of sheep ghee.

Does it improve range of motion?

Measuring the extent to which the knee can flex and extend as a result of treatment, which is crucial for normal activities.

Does it enhance physical function?

Assessing overall physical performance, including the ability to engage in daily tasks and recreational activities.

Methodology:

To achieve these objectives, the study will employ a controlled, randomized design:

Intervention Group: Participants will receive topical applications of sheep ghee on their affected knee joints.

Placebo Group: A placebo treatment involving Vaseline will be administered to a separate group of participants. This will serve to measure the effects of the treatment against a neutral control.

Control group: received only one-minute of massage.

Comparison Groups:

Researchers will conduct a comparative analysis between the sheep ghee treatment group and the placebo group receiving Vaseline. This comparison is crucial to discern any genuine therapeutic benefits attributed to sheep ghee, independent of psychological or placebo effects.

Participant Involvement:

Participants in this clinical trial will:

Topical Treatment: Apply either sheep ghee or Vaseline to their knee joints as per the group allocation.

Assessment of Outcomes: Throughout the study period, participants will complete a series of assessments designed to measure:

Knee Stiffness: Using objective scales to quantify joint stiffness. Pain Levels: Utilizing Visual Analogue Scale (VAS) to report their experiences before and after treatment.

Range of Motion: The range of motion for knee flexion (heel to thigh distance) was measured with a ruler.

Physical Function: Assessment of the condition of patients with osteoarthritis of the knee, focusing on pain, stiffness, and overall physical functioning of the joints using the WOMAC (Western Ontario and McMaster Universities Arthritis Index).

Expectations:

Through rigorous scientific evaluation, this clinical trial hopes to elucidate the potential benefits of sheep ghee in treating knee joint issues. If effective, this could introduce a novel, accessible treatment option for individuals suffering from conditions like osteoarthritis and other forms of knee pain, ultimately enhancing their quality of life.

Conclusion:

This clinical trial represents an exciting opportunity to explore traditional remedies within a modern scientific framework. By evaluating the therapeutic effects of sheep ghee, the researchers aim to contribute valuable insights to the field of joint health, potentially paving the way for new approaches in managing knee-related ailments.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Kerman
    • Rafsanjan, Kerman, Iran, Islamic Republic of, 7718796755
      • RafRafsanjan - Islamic Republic Boulevard - Nurse Street - Nursing and Midwifery School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with no injury, open wound or skin disease in the knee; no recent injury to the affected knee; no alcohol or drug addiction; no use of other complementary methods, such as physiotherapy, acupuncture or percutaneous electrical nerve stimulation; no history of knee surgery and insensitivity to Vaseline and sheep ghee; no mental illness or cognitive disorder; ability to see and walk; ability to communicate; mild to moderate pain score on the Visual Analogue Scale (VAS), and no history of intra-articular corticosteroid or hyaluronic acid injection for the past three months were included in the study

Exclusion Criteria:

• Patients who were dissatisfied, had moderate to severe local sensitivity to ghee, forgot to use the ghee or Vaseline more than twice in the intervention and placebo groups, and used less than two-thirds of the drug container during the study were excluded from the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sheep ghee; To evaluate the efficacy of sheep ghee as a therapeutic agent for improving knee joint health in participants experiencing osteoarthritis or related joint issues. The intervention group one gram (equivalent to a small ice cream spoon) of sheep ghee was applied to painful areas (front, side, and back) of the knee twice a day in the morning and at night for one month.	Other: Sheep ghee; This intervention involves the application of sheep ghee (clarified butter made from sheep milk) as a topical treatment for knee joint health in individuals suffering from osteoarthritis or other knee-related conditions. This study aims to assess the effectiveness of sheep ghee compared to a placebo (vaseline) in reducing pain and improving functionality.
Placebo Comparator: vaseline; .The placebo group received Vaseline the same way as the intervention group did at equal doses.	Other: Sheep ghee; This intervention involves the application of sheep ghee (clarified butter made from sheep milk) as a topical treatment for knee joint health in individuals suffering from osteoarthritis or other knee-related conditions. This study aims to assess the effectiveness of sheep ghee compared to a placebo (vaseline) in reducing pain and improving functionality.
No Intervention: control; The control group received only one-minute of massage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level Assessment	Pain levels will be measured using the Visual Analog Scale (VAS), a validated tool where participants indicate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).	Before and immediately after intervention
Joint Mobility Assessment	The range of motion for knee flexion (heel to thigh distance)	before and immediately after intervention
Assessment of the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the joints.	The WOMAC, a questionnaire used to assess hip and knee osteoarthritis measures three subscales on a Likert scale (None, mild, moderate, severe, extreme): 1- an assessment of knee pain in the previous 48 hours, 2- joint stiffness, and 3- physical function in the last 48 hours.	before and immediately after intervention

Collaborators and Investigators

• Sponsor: Rafsanjan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Estimated): March 11, 2025

Study Record Updates

• Last Update Posted (Estimated): March 11, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IR.RUMS.REC.1398.202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No