A clinical study to assess the effect of a Unani formulation in the gel form and medicated steam form in patients of Knee Osteoarthritis.

Comparative Clinical Evaluation of Unani Formulation in redesigned gel form with its classical Bukhoor form in the Management of Knee Osteoarthritis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048971

Enrollment

Registered

2023-01-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified Health Condition 2: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Unani formulation: the intervention will be the Unani formulation, in the form of gel to be locally applied on Knee joint in the patients of Knee OA, twice daily for one month. Control

Eligibility

Inclusion criteria

Inclusion criteria: • Patients of Knee OA according to American College of Rheumatology (ACR) criteria Clinical classification criteria plus radiographic findings (X-ray) for knee osteoarthritis. 1.Pain in for most days of the prior month and â??oneâ?? of the following three ï?¼ Morning stiffness ï?¼ Age 40 to 65 years. ï?¼ Crepitus on active knee movement 2.Presence of Osteophytes on knee Radiograph. • Patients with pain intensity score of 3 cm or more on a 10 cm visual analog scale (VAS). • Willingness and ability to accept intervention and to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: Ã? Pregnant and lactating females. Ã? Severely ill patients. Ã? History of significant trauma, infection or presence of hematoma at the site of knee and/or knee surgery. Ã? History of other musculoskeletal disorders. Ã? Known case of malignancy. Ã? Patients taking NSAIDâ??s and corticosteroids, (a wash out period of 1week and 4 weeks respectively is required before enrolling patient). Ã? Unwilling to participate in the study.

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale (VAS) for pain. KOOS (Knee injury and OA outcome score) for pain, stiffness, functions in daily living, function in sports and recreational activities, quality of life and other symptoms. 4-Point Likert Scale (0-3) for joint tenderness. Knee circumference for swelling of knee joint. Range of movements (ROM). Timepoint: Baseline, Ist Wk, 2nd wk, 3rd wk, 4th wk and 5th wk (treatment free wk).	—

Measure

Time frame

Visual Analogue Scale (VAS) for pain. KOOS (Knee injury and OA outcome score) for pain, stiffness, functions in daily living, function in sports and recreational activities, quality of life and other symptoms. 4-Point Likert Scale (0-3) for joint tenderness. Knee circumference for swelling of knee joint. Range of movements (ROM). Timepoint: Baseline, Ist Wk, 2nd wk, 3rd wk, 4th wk and 5th wk (treatment free wk).

—

Secondary

Measure	Time frame
Response of patient to the therapy on a 5-point Likert Scale (0-4) by patientâ??s Global Assessment (PGA). Response of investigator to the therapy on a 5-point Likert Scale (0-4) Investigatorâ??s Global Assessment (IGA). SF-12 for quality-of-life assessment. Timepoint: 4 weeks	—

Countries

India

Contacts

Public ContactAzhar Jabin

Jamia Hamdard (Deemed to be University),New-Delhi

ajabin@jamiahamdard.ac.in9899315252

Outcome results

None listed

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