NCT02612974

Brief Summary

This study has been designed to conduct as Randomized comparative clinical study.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 knee-osteoarthritis

Timeline
Completed

Started Jan 2010

Typical duration for phase_2 knee-osteoarthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

November 20, 2015

Last Update Submit

November 23, 2015

Conditions

Knee Osteoarthritis

Keywords

Qurse mafasilleech therapyHirudinaria granulosa

Outcome Measures

Primary Outcomes (5)

  • KOOS Score

    end of 6 weeks

  • VAS

    end of 6 weeks

  • Active Range of Motion

    end of 6 weeks

  • Knee circumference

    end of 6 weeks

  • 15 m walking time test

    end of 6 weeks

Secondary Outcomes (1)

  • KOOS subscores

    end of 6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Hirudinaria granulosa and Qurse mafasil are given

Biological: Hirudinaria granulosa, qurse mafasil

Group B

ACTIVE COMPARATOR

Qurse mafasil only given

Biological: Hirudinaria granulosa, qurse mafasil

Interventions

Hirudinaria granulosa, qurse mafasilBIOLOGICAL

compare the efficacy of both groups

Also known as: leech and drug
Group AGroup B

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee osteoarthritis

You may not qualify if:

  • pregnancy,
  • lactation,
  • anaemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

LeechingPharmaceutical Preparations

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 24, 2015

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

November 24, 2015

Record last verified: 2015-11