Primary Knee OsteoarthritisPhase 2NCT06184685
Safety and Efficacy of Sahasthara ME vs Diclofenac ME for Treating Primary Knee Osteoarthritis
A Phase 2 study testing Sahasthara Microemulsion and Diclofenac Microemulsion in people with Primary Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
Trial summary
Background: Sahasthara is a traditional Thai herbal remedy used for the anti-inflammatory treatment of the musculoskeletal system, while diclofenac sodium is one of the most topically administered anti-inflammatory drug. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Primary Knee Osteoarthritis
- What is being tested?
- Sahasthara Microemulsion and Diclofenac Microemulsion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteThailand
- Study dates
- 20 Oct 2021to 8 Dec 2021
- 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
- who had a pain score higher than 30 mm out of 100 mm on the visual analog scale (VAS)
- experiencing moderate to severe pain intensity from OA in one or both knees (patients who affected by knee OA bilaterally were evaluated, which more severely affected knee was included in the study) and had OA grade 1 to 3 (moderate/medium degree of pain) according to the Kellgren-Lawrence classification grading scale for OA severity
Who cannot join
- had a history of hypersensitivity to ingredients in SHT ME or DF-ME
- were pregnant or breast feeding
- had previous surgery knee replacement or intra-articular steroid injections within 3 months of inclusion in the study
- were having any coexisting musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout, pseudogout, and traumatic arthritis ) or dermatologic disorder which affected the surrounding skin of the knees
- was assessed by body mass index (BMI) more than 32 kg/m2
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University
Klong Luang, Changwat Pathum Thani, 12120
About this study
Official title: A Comparative Double-Blinded Randomized Study: Clinical Safety and Efficacy of Sahasthara Microemulsion Versus Diclofenac Microemulsion for Treating Primary Knee Osteoarthritis
Background: Sahasthara is a traditional Thai herbal remedy used for the anti-inflammatory treatment of the musculoskeletal system, while diclofenac sodium is one of the most topically administered anti-inflammatory drug. However, there has not been scientifically researched regarding the efficacy and safety of SHT formulated as ME.
Purpose: To assess the safety and effectiveness of Sahasthara microemulsion (SHT-ME) in comparison to a diclofenac microemulsion (DF-ME) in treating primary osteoarthritis (OA) of the knee.
Methods: A randomized, double blinded clinical trial phase II was conducted. One treatment group received 1% SHT-ME, while the other received 2% DF-ME (2 ml, 3 times per day for 28 days) on their affected knee area. All patients were followed up at 14 and 28 days. Changes in the visual analogue scale (VAS) for pain as well as 100-meter walking times, the WOMAC index scores, and a global assessment were examined for efficacy. Clinical examinations, abnormalities in laboratory tests, and the incidence of adverse events (AEs) were assessed for safety.
Read the detailed description
Outpatient participants, aged between 40 - 70 years old, were recruited. They were screened for symptoms of primary knee OA at the Department of Orthopedics, Thammasat University Hospital, Pathum Thani, Thailand, between October - December 2021. A diagnosis of knee OA in this clinical trial were made with a combination of clinical and radiographic findings according to the American College of Rheumatology (ACR). Inclusion criteria for participants were those who had a pain score higher than 30 mm out of 100 mm on the visual analog scale (VAS), experiencing moderate to severe pain intensity from OA in one or both knees (patients who affected by knee OA bilaterally were evaluated, which more severely affected knee was included in the study) and had OA grade 1 to 3 (moderate/medium degree of pain) according to the Kellgren-Lawrence classification grading scale for OA severity. The subjects would be excluded if they: 1) had a history of hypersensitivity to ingredients in SHT ME or DF-ME, 2) were pregnant or breast feeding, 3) had previous surgery knee replacement or intra-articular steroid injections within 3 months of inclusion in the study, 4) were having any coexisting musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout, pseudogout, and traumatic arthritis ) or dermatologic disorder which affected the surrounding skin of the knees, or 5) was assessed by body mass index (BMI) more than 32 kg/m2. The participants who were accepted to enroll in the study signed an informed consent.
Following enrollment, eligible patients were given a washout period of one week with no administration of analgesics before being randomly assigned to receive one of the treatments daily for 4 weeks. A randomized code number from a non-stratified randomization list generated by computer was used. The physicians, researchers, and statisticians were blinded from the allocation of patients involved in the trial. During the study, they were instructed not to use other analgesics, including injection drugs or other medications. Following the baseline visit, patients returned to the study site after 2 and 4 weeks for follow-up assessments of safety, efficacy and study protocol compliance.
In the trial, demographic data, clinical signs and symptoms, physical examination, visual analogue scale (VAS) for pain, 100-meter walk times, the WOMAC index scores (pain, physical function, stiffness), and laboratory tests (fasting blood sugar, lipid profile, liver function tests (AST, ALT, ALP), and renal function tests (BUN, creatinine clearance)) were collected as baseline data and as study data on day 14 and on day 28
- Conditions
- Primary Knee Osteoarthritis
- Being tested
- Sahasthara Microemulsion, Diclofenac Microemulsion
- Keywords
- Clinical, Topical, Microemulsion, Sahasthara, Diclofenac, Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sahasthara MicroemulsionDrug
Also called Diclofenac Microemulsion
All patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding.
Diclofenac MicroemulsionDrug
All patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding.
| Study group | Role | What they receive |
|---|---|---|
| Sahasthara Microemulsion | Experimental | The extract of Sahasthara remedy was obtained by maceration with 95% ethanol for 3 days. The marc was re-extracted using the same process two more times. After that, the extract was filtered, concentrated using a rotary evaporator at 40 degree C and vacuum (Rotavapor R-205, Buchi, Switzerland), to gave a yield of 10.3% w/w. Finally, SHT ethanolic extract was formulated into a microemulsion with 1% (w/w) of extract and was stored in 50 ml bottles. Receives: Drug: Sahasthara Microemulsion |
| Diclofenac Microemulsion | Experimental | DF-ME, which consists of 2% diclofenac sodium, was compounded according to the published instructions by RS Therapeutics Inc. (Canada) and stored in the same containers as SHT-ME. Receives: Drug: Diclofenac Microemulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The WOMAC index
It is a self-administered questionnaire from the latest version of WOMAC 3.1 (the Western Ontario and McMaster Universities Osteoarthritis Index) (Haq \& Davatchi, 2011; Roos et al., 1999). The patients were evaluated by the WOMAC index in terms of three domains: pain score ranged from 0 (no pain) to 4 (extreme pain); physical function score ranged from 0 (no difficulty) to 4 (the most severe difficulty); stiffness score ranged from 0 (no stiffness) to 4 (the worst stiffness).
Measured: 28 days (ฺDay0, Day14, Day28)
Secondary outcomes (1)
The visual analogue scale (VAS)
The pain intensity was measured using the visual analogue scale (VAS), a 100-mm line representing the continuum of pain degree, arranged into 3 levels of pain: mild = 0-30; moderate = 31-60; and maximum pain = 61-100 (Haefeli \& Elfering, 2006).
Measured: 28 days (ฺDay0, Day14, Day28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start20 Oct 2021
- Primary completion17 Nov 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ninnart Intharit, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184685
- Sponsor's protocol ID
- Ninnart Intharit 01
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: During publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Double-Blinded Randomized Study: Clinical Safety and Efficacy of Sahasthara Microemulsion Versus Diclofenac Microemulsion for Treating Primary Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06184685
- Acronym / sponsor ID
- Ninnart Intharit 01
- Conditions
- Primary Knee Osteoarthritis
- Keywords
- Clinical, Topical, Microemulsion, Sahasthara, Diclofenac, Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 28 Dec 2023 (actual)
- 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.
Background: Sahasthara is a traditional Thai herbal remedy used for the anti-inflammatory treatment of the musculoskeletal system, while diclofenac sodium is one of the most topically administered anti-inflammatory drug. However, there has not been scientifically researched regarding the efficacy and safety of SHT formulated as ME.
Purpose: To assess the safety and effectiveness of Sahasthara microemulsion (SHT-ME) in comparison to a diclofenac microemulsion (DF-ME) in treating primary osteoarthritis (OA) of the knee.
Methods: A randomized, double blinded clinical trial phase II was conducted. One treatment group received 1% SHT-ME, while the other received 2% DF-ME (2 ml, 3 times per day for 28 days) on their affected knee area. All patients were followed up at 14 and 28 days. Changes in the visual analogue scale (VAS) for pain as well as 100-meter walking times, the WOMAC index scores, and a global assessment were examined for efficacy. Clinical examinations, abnormalities in laboratory tests, and the incidence of adverse events (AEs) were assessed for safety.
Detailed description
Outpatient participants, aged between 40 - 70 years old, were recruited. They were screened for symptoms of primary knee OA at the Department of Orthopedics, Thammasat University Hospital, Pathum Thani, Thailand, between October - December 2021. A diagnosis of knee OA in this clinical trial were made with a combination of clinical and radiographic findings according to the American College of Rheumatology (ACR). Inclusion criteria for participants were those who had a pain score higher than 30 mm out of 100 mm on the visual analog scale (VAS), experiencing moderate to severe pain intensity from OA in one or both knees (patients who affected by knee OA bilaterally were evaluated, which more severely affected knee was included in the study) and had OA grade 1 to 3 (moderate/medium degree of pain) according to the Kellgren-Lawrence classification grading scale for OA severity. The subjects would be excluded if they: 1) had a history of hypersensitivity to ingredients in SHT ME or DF-ME, 2) were pregnant or breast feeding, 3) had previous surgery knee replacement or intra-articular steroid injections within 3 months of inclusion in the study, 4) were having any coexisting musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout, pseudogout, and traumatic arthritis ) or dermatologic disorder which affected the surrounding skin of the knees, or 5) was assessed by body mass index (BMI) more than 32 kg/m2. The participants who were accepted to enroll in the study signed an informed consent.
Following enrollment, eligible patients were given a washout period of one week with no administration of analgesics before being randomly assigned to receive one of the treatments daily for 4 weeks. A randomized code number from a non-stratified randomization list generated by computer was used. The physicians, researchers, and statisticians were blinded from the allocation of patients involved in the trial. During the study, they were instructed not to use other analgesics, including injection drugs or other medications. Following the baseline visit, patients returned to the study site after 2 and 4 weeks for follow-up assessments of safety, efficacy and study protocol compliance.
In the trial, demographic data, clinical signs and symptoms, physical examination, visual analogue scale (VAS) for pain, 100-meter walk times, the WOMAC index scores (pain, physical function, stiffness), and laboratory tests (fasting blood sugar, lipid profile, liver function tests (AST, ALT, ALP), and renal function tests (BUN, creatinine clearance)) were collected as baseline data and as study data on day 14 and on day 28
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 |
|---|---|---|
| Sahasthara Microemulsion | Experimental | Drug: Sahasthara MicroemulsionThe extract of Sahasthara remedy was obtained by maceration with 95% ethanol for 3 days. The marc was re-extracted using the same process two more times. After that, the extract was filtered, concentrated using a rotary evaporator at 40 degree C and vacuum (Rotavapor R-205, Buchi, Switzerland), to gave a yield of 10.3% w/w. Finally, SHT ethanolic extract was formulated into a microemulsion with 1% (w/w) of extract and was stored in 50 ml bottles. |
| Diclofenac Microemulsion | Experimental | Drug: Diclofenac MicroemulsionDF-ME, which consists of 2% diclofenac sodium, was compounded according to the published instructions by RS Therapeutics Inc. (Canada) and stored in the same containers as SHT-ME. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- who had a pain score higher than 30 mm out of 100 mm on the visual analog scale (VAS)
- experiencing moderate to severe pain intensity from OA in one or both knees (patients who affected by knee OA bilaterally were evaluated, which more severely affected knee was included in the study) and had OA grade 1 to 3 (moderate/medium degree of pain) according to the Kellgren-Lawrence classification grading scale for OA severity
Key exclusion criteria (5 listed)
- had a history of hypersensitivity to ingredients in SHT ME or DF-ME
- were pregnant or breast feeding
- had previous surgery knee replacement or intra-articular steroid injections within 3 months of inclusion in the study
- were having any coexisting musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout, pseudogout, and traumatic arthritis ) or dermatologic disorder which affected the surrounding skin of the knees
- was assessed by body mass index (BMI) more than 32 kg/m2
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 |
|---|---|---|
| Sahasthara MicroemulsionAlso: Diclofenac MicroemulsionAll patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding. | Drug | Sahasthara Microemulsion |
| Diclofenac MicroemulsionAll patients were instructed to treat the knee with 2 ml, 3x/day, for 28 days. Each of the patients received the same appearance of drug packaging, which was not revealed until data analysis was completed, or medical emergency conditions would require an unblinding. | Drug | Diclofenac Microemulsion |
Primary outcome
The WOMAC index
Time frame: 28 days (ฺDay0, Day14, Day28)
It is a self-administered questionnaire from the latest version of WOMAC 3.1 (the Western Ontario and McMaster Universities Osteoarthritis Index) (Haq \& Davatchi, 2011; Roos et al., 1999). The patients were evaluated by the WOMAC index in terms of three domains: pain score ranged from 0 (no pain) to 4 (extreme pain); physical function score ranged from 0 (no difficulty) to 4 (the most severe difficulty); stiffness score ranged from 0 (no stiffness) to 4 (the worst stiffness).
1 secondary outcome
The visual analogue scale (VAS)
Time frame: 28 days (ฺDay0, Day14, Day28)
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 28 Dec 2023.
- Individual participant dataSharing planned: No. During publication
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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 Sahasthara Microemulsion and Diclofenac Microemulsion in people with Primary Knee Osteoarthritis, 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 2 inclusion and 5 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 28 Dec 2023. 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?
The WOMAC index (time frame: 28 days (ฺDay0, Day14, Day28)). 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 28 Dec 2023.