Safety and efficacy of Irsal-i-Alaq (Leeching) in Waja-al- Rukba (Knee steoarthritis)
- Conditions
- Health Condition 1: null- Osteoarthritis of Knee Joint
- Registration Number
- CTRI/2017/04/008382
- Lead Sponsor
- Jamia Hamdard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Patients of Knee OA in age groups of 35 years to 65 years.
Subjective pain intensity of 20 mm or more at baseline on Visual Analogue Scale (VAS).
Clinically stable patients.
Patients of both sexes.
Patients willing to sign the informed consent form and participate in the trial voluntarily.
Diabetes mellitus Type 1 and uncontrolled Type 2.
Active hepatic disease, abnormal liver function. (Alanine transaminase, Aspartate transaminase or Total bilirubin level more than twice normal values), or renal dysfunction (blood creatinine over the upper limit of normal).
Current anticoagulant therapy or bleeding disorders or Severe Anaemia.
Pregnant and lactating mothers.
ESR > 40 mm/hr.
Terminally ill patients.
Patients below 35 years and above 65 years of age.
Patients who fail to give consent.
Subjects who had received leeching to the knee region 1 months prior to the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS). <br/ ><br>WOMAC Index (Modified â?? CRD Pune Version) / KOOS <br/ ><br>Active range of motion using Goniometer. <br/ ><br>Rescue medication use <br/ ><br>X ray Knee AP & Lateral views (Kellgren -Lawrence Grading Scale). <br/ ><br>Urinary Pyridinoline (Pyd) <br/ ><br>Timepoint: Visual Analogue Scale (VAS)at Day Zero and 28th day <br/ ><br>WOMAC Index (Modified â?? CRD Pune Version) / KOOS at Day Zero and 28th day <br/ ><br>Active range of motion using Goniometer at day Zero and 28th day <br/ ><br>Rescue medication use from Day zero upto 28th day <br/ ><br>X ray Knee AP & Lateral views (Kellgren -Lawrence Grading Scale)at day zero and 28th day <br/ ><br>Urinary Pyridinoline (Pyd) at day zero and 28th day
- Secondary Outcome Measures
Name Time Method I.To evaluate the effect of Irsal-i-Alaq (Leeching) on the progression of disease process in Waja-al-Rukba (knee OA) patients.Timepoint: Base line and 28th day