Osteoarthritis, KneePhase 2NCT02286453
Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac
A Phase 2 study testing Benjakul recipe and diclofenac in people with Osteoarthritis, Knee, run by Thammasat University at 1 site in Thailand.
Trial summary
Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine) Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Benjakul recipe and diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2014to Sep 2015
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary osteoarthritis of knee with grade I-III of Kellgren \& Lawrence criteria
- Not during breast feeding
- Not during pregnancy with a good contraception
- Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
- Do not abuse drugs
- Good cooperation
Who cannot join
- BMI > 32
- History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
- History of allergy diclofenac or allergy herbal medicine
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University (Ruangsit campus)
Khlong Luang, Changwat Pathum Thani, 10120
About this study
Official title: Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Benjakul recipe, diclofenac
- Keywords
- Osteoarthritis of The knee, Benjakul, Alternative Medicine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benjakul recipeDrug
Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days
diclofenacDrug
diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Benjakul Receives: Drug: Benjakul recipe |
| 2 | Active comparator | diclofenac Receives: Drug: diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score from Visual analog scale
Measured: 28 days
Secondary outcomes (1)
Pain score
Pain score from Modified WOMAC score (from Modified Thai WOMAC index)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Collaborators
- Thai Traditional Medical Knowledge Fund
- Responsible party
- Principal investigator, Patamaporn Rachawat, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286453
- Sponsor's protocol ID
- MTU-EC-ES-6-152/56
- Other IDs
- TCTR20140816001
- Status last verified
- Sep 2015
- First submitted
- 5 Nov 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of Benjakul Recipe in Treating Primary Osteoarthritis of Knee Compared With Diclofenac (Clinical Trial Phase II)
- ClinicalTrials.gov ID
- NCT02286453
- Acronym / sponsor ID
- MTU-EC-ES-6-152/56
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis of The knee, Benjakul, Alternative Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Collaborators
- Thai Traditional Medical Knowledge Fund
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Nov 2014 (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.
Efficacy and adverse effects of Benjakul recipe in Treating Primary Osteoarthritis of Knee Compared with Diclofenac. This study was designed as double blind, randomized controlled trial. Approval from the ethical committee of Human Research Ethics Committee of Thammasat University (No: 1 Faculty of Medicine)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Benjakul recipeBenjakul |
| 2 | Active comparator | Drug: diclofenacdiclofenac |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with primary osteoarthritis of knee with grade I-III of Kellgren \& Lawrence criteria
- Not during breast feeding
- Not during pregnancy with a good contraception
- Volunteer have a normal Complete Blood Count laboratory, lipid profiles,liver function tests and renal funtion tests
- Do not abuse drugs
Key exclusion criteria (3 listed)
- BMI > 32
- History of peptic ulcer, Gastroesophageal reflux disease (GERD), heart disease, liver disease or kidney disease
- History of allergy diclofenac or allergy herbal medicine
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 |
|---|---|---|
| Benjakul recipeBenjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days | Drug | 1 |
| diclofenacdiclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days | Drug | 2 |
Primary outcome
Pain score
Time frame: 28 days
Pain score from Visual analog scale
1 secondary outcome
Pain score
Time frame: 28 days
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 29 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benjakul recipe and diclofenac in people with Osteoarthritis, Knee, run by Thammasat University at 1 site in Thailand.
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 6 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 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pain score (time frame: 28 days). 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 29 Sep 2015.