Knee OsteoarthritisPhase 2Leech TherapyNCT02612974
Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
A Phase 2 study testing Hirudinaria granulosa, qurse mafasil in people with Knee Osteoarthritis, run by Hamdard University.
Trial summary
This study has been designed to conduct as Randomized comparative clinical study. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hirudinaria granulosa, qurse mafasil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee osteoarthritis
Who cannot join
- pregnancy,
- lactation,
- anaemia
About this study
Official title: Randomized Controlled Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
This study has been designed to conduct as Randomized comparative clinical study.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hirudinaria granulosa, qurse mafasil
- Keywords
- Qurse mafasil, leech therapy, Hirudinaria granulosa
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hirudinaria granulosa, qurse mafasilBiological
Also called leech and drug
compare the efficacy of both groups
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Hirudinaria granulosa and Qurse mafasil are given Receives: Biological: Hirudinaria granulosa, qurse mafasil |
| Group B | Active comparator | Qurse mafasil only given Receives: Biological: Hirudinaria granulosa, qurse mafasil |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS Score
Measured: end of 6 weeks
VAS
Measured: end of 6 weeks
Active Range of Motion
Measured: end of 6 weeks
Knee circumference
Measured: end of 6 weeks
15 m walking time test
Measured: end of 6 weeks
Secondary outcomes (1)
KOOS subscores
Measured: end of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJan 2010
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamdard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. S. M. Shiffa, Hamdard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612974
- Sponsor's protocol ID
- 2009/AD/JH/058
- Acronym
- Leech Therapy
- Status last verified
- Nov 2015
- First submitted
- 20 Nov 2015
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Evaluation of Leech Therapy in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02612974
- Acronym / sponsor ID
- Leech Therapy / 2009/AD/JH/058
- Conditions
- Knee Osteoarthritis
- Keywords
- Qurse mafasil, leech therapy, Hirudinaria granulosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hamdard UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Hirudinaria granulosa, qurse mafasilHirudinaria granulosa and Qurse mafasil are given |
| Group B | Active comparator | Biological: Hirudinaria granulosa, qurse mafasilQurse mafasil only given |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- knee osteoarthritis
Key exclusion criteria (3 listed)
- pregnancy,
- lactation,
- anaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hirudinaria granulosa, qurse mafasilAlso: leech and drugcompare the efficacy of both groups | Biological | Group A, Group B |
Primary outcome
KOOS Score
Time frame: end of 6 weeks
VAS
Time frame: end of 6 weeks
Active Range of Motion
Time frame: end of 6 weeks
Knee circumference
Time frame: end of 6 weeks
15 m walking time test
Time frame: end of 6 weeks
1 secondary outcome
KOOS subscores
Time frame: end of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hirudinaria granulosa, qurse mafasil in people with Knee Osteoarthritis, run by Hamdard University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS Score (time frame: end of 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2015.