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Clinical trial to study the effectiveness of a unani formation, Habb-e-Mafasil, in Primary Knee Osteoarthritis.

Phase 2
Conditions
Health Condition 1: M170- Bilateral primary osteoarthritis of knee
Registration Number
CTRI/2024/02/062496
Lead Sponsor
Central Council for Research In Unani Medicine New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

patients irrespective of gender in the age group of 20 to 65 years will be included. clically and radiologically diagnosed patients with kellegren-lawrence grades 1,2 and 3 and with BMI less than 35 kg per meter square. patients who have agreed to sign the informed consent form and are willing to follow up as per the study protocol.

Exclusion Criteria

1. Kellgren- Lawrence grade 4 knee osteoarthritis.

2. Pregnant and Lactating women.

3. BMI more than 35kg per meter square.

4. History of recent knee infection.

5. Prior knee surgery.

6. Prior bone disease such as Osteomyelitis

7. Prior trauma to the knee joint.

8. Patients having received intra-articular knee injection as that of corticosteroids or hyaluronic acid or any investigational drug in the past one month.

9. Known cases of inflammatory joint disease as Rheumatoid Arthritis.

10. Patients with history of any significant systemic diseases like cardiovascular, gastrointestinal, renal, hepatic.

11. Patients with uncontrolled diabetes mellitus and hypertension.

12. Patients who refuse to give the written consent for the study and unwillingness to come for regular follow up as described in the study plan.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Pain in knee joint. <br/ ><br>2. Stiffness in knee joint after inactivity. <br/ ><br>3. Restriction of joint movements. <br/ ><br>4. Swelling either with or without effusion. <br/ ><br>5. Crepitus <br/ ><br>6. TendernessTimepoint: At day 0, 14 and 28
Secondary Outcome Measures
NameTimeMethod
X Ray bilateral knee joints AP and LateralTimepoint: day 0 and 28
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