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Clinical study of Qurs-e-Mafasil Jadeed with and without Hijama in knee joints pai

Phase 2
Conditions
Health Condition 1: M179- Osteoarthritis of knee, unspecified
Registration Number
CTRI/2019/04/018450
Lead Sponsor
Central Council for Research in Unani Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Patients of any sex aged 40-70 years

Patients having Moderate to severe Knee pain (pain more than 40 mm and less than 90 mm) after 50 feet Walking on a flat surface

Patients of Knee OA with chronicity of more or equal to 6 months

Patients having K L Grading criteria of grades II or III

Patients with normal laboratory values.

Patients willing to comply with the regular treatment schedule as per protocol

Exclusion Criteria

Anemia (less than 10g percent of Hb) and bleeding disorders

Pregnant and Lactating Mothers

Another type of arthritis, eg Rheumatoid arthritis, Psoriatic arthritis, Gouty arthritis

Patients taking Anticoagulants, corticosteroid or NSAIDs or any other concomitant therapy

History of Surgery, Tidal lavage/Arthroscopy of the joint involved, of affected knee within the past 1 year. Intra-articular (IA) corticosteroid injection of affected knee within a 3 months interval prior to baseline screening

Patients with the gastro-intestinal disease, peptic ulcer and having fecal blood loss

History of Systemic illness such as Liver, Kidney, Cardiac disorders, DM, HTN, Osteomyelitis, Tuberculosis,

Known cases of Immunocompromised states (HIV or AIDS, etc.)/ Malignancies

Patients who were not willing to be randomized

Ongoing use of prohibited medication including NSAID, another oral analgesic, muscle relaxant, or a low-dose antidepressant for any chronic pain management

Concomitant skin disease at the application site

History of alcohol or Drug abuse, excessive smoking,

Diagnosed neurological or psychiatric disorders

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Tenderness on the joint area <br/ ><br>Effusion and Swelling over the affected joint <br/ ><br>Range of movements (Goniometry) <br/ ><br>Walking timeTimepoint: At baseline, 2wk, 4wk, 6wk and end of the 8wk
Secondary Outcome Measures
NameTimeMethod
X-ray grading <br/ ><br>Biomarkers used <br/ ><br>Assessment of safetyTimepoint: At baseline and end of the 8wk
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