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Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis (Leech Therapy)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hirudinaria granulosa, qurse mafasil
Sponsored by
Hamdard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Qurse mafasil, leech therapy, Hirudinaria granulosa

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • knee osteoarthritis

Exclusion Criteria:

  • pregnancy,
  • lactation,
  • anaemia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A

    Group B

    Arm Description

    Hirudinaria granulosa and Qurse mafasil are given

    Qurse mafasil only given

    Outcomes

    Primary Outcome Measures

    KOOS Score
    VAS
    Active Range of Motion
    Knee circumference
    15 m walking time test

    Secondary Outcome Measures

    KOOS subscores

    Full Information

    First Posted
    November 20, 2015
    Last Updated
    November 23, 2015
    Sponsor
    Hamdard University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02612974
    Brief Title
    Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
    Acronym
    Leech Therapy
    Official Title
    Randomized Controlled Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hamdard University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study has been designed to conduct as Randomized comparative clinical study.
    Detailed Description
    Two groups, group B received Qurse Mafasil tablet orally two tablets two times daily for 8 weeks while group A received Leech therapy once weekly for 8 weeks along with Qurse mafasil.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Qurse mafasil, leech therapy, Hirudinaria granulosa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Hirudinaria granulosa and Qurse mafasil are given
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    Qurse mafasil only given
    Intervention Type
    Biological
    Intervention Name(s)
    Hirudinaria granulosa, qurse mafasil
    Other Intervention Name(s)
    leech and drug
    Intervention Description
    compare the efficacy of both groups
    Primary Outcome Measure Information:
    Title
    KOOS Score
    Time Frame
    end of 6 weeks
    Title
    VAS
    Time Frame
    end of 6 weeks
    Title
    Active Range of Motion
    Time Frame
    end of 6 weeks
    Title
    Knee circumference
    Time Frame
    end of 6 weeks
    Title
    15 m walking time test
    Time Frame
    end of 6 weeks
    Secondary Outcome Measure Information:
    Title
    KOOS subscores
    Time Frame
    end of 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: knee osteoarthritis Exclusion Criteria: pregnancy, lactation, anaemia

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis

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