Health Condition 1: M17- Osteoarthritis of knee
Conditions
Interventions
Intervention1: HABBE GULE AAK: Composition:
1.Zanjabeel(Zingiber officinalis Roscoe.)
2.Filfil Siyah(Piper nigrum L. )
3.Gule Madar/Aak(Calotropis gigantea (L.)
W. T. Aiton )
4.Barge Bans(Bambusa bam
Sponsors
National Research Institute of Unani Medicine For Skin Disorders
Central Council for Research in Unani MedicineCCRUM
Eligibility
Inclusion criteria
Inclusion criteria: The participants will be included in the study on the basis of the following criteria- Participants of any gender aged between 50 and 65 years Clinical and Radiographic Knee Osteoarthritis as per the following American College of Rheumatology (ACR) criteria. a. Knee Pain b. Osteophytes on Knee Radiograph, and c. At least 1 of the following 3 criteria: i. Age more than or equal to 50 years ii. Morning Stiffness lasting less than or equal to 30 minutes iii. Crepitus on Active Knee Motion Knee OA of Kellgren-Lawrence Grade 1 to 3. Body Mass Index (BMI)- less than 40 Kg per m2 Participants willing to sign the ICF and to comply with the protocol
Exclusion criteria
Exclusion criteria: The following participants will be excluded from the study: Age less than 50 years and more than 65 years. Knee OA of Kellgren-Lawrence grade IV. BMI more than or equal to 40 Patients with Knee Joint Effusion. Secondary OA, Inflammatory joint diseases (e.g., RA, ankylosing spondylitis, psoriatic arthritis, gout), or any other type of arthritis . Patients on long-term steroid treatment. H/o having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month Any significant systemic diseases (hepatic, renal, gastrointestinal, cardiovascular, neurologic or psychiatric disorder) and Diabetes Mellitus. History of Peptic Ulcer Disease and Bleeding Disorders Known hypersensitivity to study drug or any of its ingredients Pregnant and lactating women H/o addiction (alcohol, drugs) Participants not willing to sign the ICF and to attend treatment schedule regularly Patients considered not eligible in the Investigator s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in WOMAC Scores from baseline to 4 weeks of treatment Pain Sub-score Stiffness Sub-score Physical Function Sub-score Total WOMAC IndexTimepoint: 2,4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of Safety by: a. Monitoring Adverse Events (AEs): Adverse effects related to either the Unani drug or control drug will be documented at each clinical assessment visit (weeks 2 & 4), both as reported by the participants, & observed by the physician during clinical examination. b. Changes in Laboratory Parameters (performed at baseline & at week 4): Hemogram: Hb, TLC, DLC, RBC, Platelets, ESR LFTs: S. Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase KFTs: Serum Creatinine, Blood Urea, Serum Uric Acid Urine Examination: Routine & Microscopic 2. Change in Visual Analogue Scale (VAS) Pain Score (Baseline to 4 Weeks) Knee Pain on VAS at Rest Knee Pain on VAS on Weight Bearing Knee Pain on VAS during Active Movements 3.Change in Joint Tenderness Score on 4-Point Likert Scale (Baseline to 4 Weeks) 4. Change in 50-Foot Walk TestTimepoint: At baseline,2,4 weeks | — |
Countries
India
Contacts
Public ContactDR. MD RUMMAN
National Research Institute of Unani Medicine For Skin Disorders
Outcome results
None listed