A clinical trial to study the effect of wet cupping in comparison to Diclofenac gel in patients with knee osteoarthritis

Phase 3

Completed

• Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: M170- Bilateral primary osteoarthritis of kneeHealth Condition 3: null- knee osteoarthritis

• Registration Number: CTRI/2017/12/010901
• Lead Sponsor: Jamia Hamdard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-09-28
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Patients diagnosed according to American College of Rheumatology Criteria for Osteoarthritis.

2. Patients with symptoms consistent with OA of knee for at least six months prior to screening.

3. Patients who discontinued all NSAIDS or other analgesic medication taken for any other condition, including their knee pain.

4. Patients signed the informed consent and follow the protocol voluntarily

Exclusion Criteria

1. Pregnancy and lactation

2. Anemia

3. Uncontrolled Diabetes Mellitus

4. Patients taking anticoagulants

5. Patients with a past history of blood disorders

6. Patients participated in an experimental device, study or any clinical trial

within the previous 30 days prior to screening

7. Any knee surgery in the previous three months

8. Other types of arthritis

9. Patients with any inter current disease(s) or condition(s) that may interfere

with the completion of six week follow upâ??neurological problems, severe

congenital defects, peptic ulcer, severe liver disease, severe coronary disease,

hypertension, renal disease, abnormal mental state, or other clinically

significant conditions

10. Patients on steroid therapy or NSAIDS.

11. Patients unable to understand WOMAC questionnaire form.

12. Patients allergic to topical diclofenac gel and with a history of gastritis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Index. <br/ ><br>Active range of motion. <br/ ><br>Radiological assessment (Kellgren-Lawrence Radiographic Grading Scale of Osteoarthritis of the Tibiofemoral Joint, all Grades) <br/ ><br>Visual analogue scale (VAS)Timepoint: The assessments of efficacy was made at day 28 and 42 (for WOMAC Index, Active Range of Motion and VAS. Laboratory and radiological assessment WAS made only at day 42.

Secondary Outcome Measures

Name	Time	Method
To provide safe alternative and economical treatment for knee osteoarthritisTimepoint: To provide safe alternative and economical treatment for knee osteoarthritis