OsteoarthritisPhase 2NCT04591795
Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
A Phase 2 study testing Sahastara remedy extract and Diclofenac in people with Osteoarthritis, run by Mr NARIN KAKATUM at 1 site in Thailand.
Trial summary
To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Sahastara remedy extract and Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2018to 13 Oct 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No pregnancy
- No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
- No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study
Who cannot join
- Uncontrolled Hypertension (BP>140/90 mm.Hg.) BMI > 30
- Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
- On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)
To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).
Read the detailed description
Sample size 66 volunteers
The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.
- Conditions
- Osteoarthritis
- Being tested
- Sahastara remedy extract, Diclofenac
- Keywords
- Sahastara, Osteoarthritis, Herbal Medicine
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sahastara remedy extractDrug
Also called SHT extract
The concentration of SHT extract is 100 mg per capsule
DiclofenacDrug
Diclofenac sodium, 25 mg enteric-coated tablets
| Study group | Role | What they receive |
|---|---|---|
| 100 mg SHT extract | Experimental | Drug: Sahastara remedy alcoholic extract comparison with diclofenac Receives: Drug: Diclofenac |
| 25 mg dicolfenac | Experimental | Drug: diclofenac comparison with diclofenac Receives: Drug: Sahastara remedy extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score 1
Pain score from Visual analog scale
Measured: 28 day
Secondary outcomes (1)
Pain score 2
Pain score from Modified WOMAC score (from Modified Thai WOMAC index)
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2018
- Primary completion13 Oct 2020
- Study completion13 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mr NARIN KAKATUM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mr NARIN KAKATUM, Thammasat University
- Investigators
- Associate Professor Arunporn Itharat, Ph.D., Study director, faculty of Medicine, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591795
- Sponsor's protocol ID
- MTU-EC-TM-2-116_2/59
- Status last verified
- Oct 2020
- First submitted
- 30 May 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sahastara Remedy Extract Capsules in Treating Primary Osteoarthritis of the Knee Compared With Diclofenac (Clinical Trial Phase II)
- ClinicalTrials.gov ID
- NCT04591795
- Acronym / sponsor ID
- MTU-EC-TM-2-116_2/59
- Conditions
- Osteoarthritis
- Keywords
- Sahastara, Osteoarthritis, Herbal Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mr NARIN KAKATUMUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 13 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (estimated)
- First posted
- 19 Oct 2020 (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.
To study efficacy and safety of Sahastara 95% ethanolic extract capsules compared to treatment Primary osteoarthritis for primary osteoarthritis, it was compared with diclofenac (Phase II).
Detailed description
Sample size 66 volunteers
The patients were divided randomly into 2 treatment groups. The patients in group 1 received the SHT extract 300 mg/day (1 capsule of 100 mg SHT extract three times daily before meals). The patients in group 2 received diclofenac sodium 75 mg/day (1 capsule of 25 mg diclofenac three times daily after meals). In addition, the patients in both groups received 20 mg of omeprazole, 1 capsule before breakfast for protects of Gastrointestinal adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 mg SHT extract | Experimental | Drug: DiclofenacDrug: Sahastara remedy alcoholic extract comparison with diclofenac |
| 25 mg dicolfenac | Experimental | Drug: Sahastara remedy extractDrug: diclofenac comparison with diclofenac |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No pregnancy
- No Serious Medical Condition evaluated by Physical Examination and Laboratory results in 1 month before study
- No Supplementary food and/or Vitamin during the study Able to follow suggestion during the study
Key exclusion criteria (3 listed)
- Uncontrolled Hypertension (BP>140/90 mm.Hg.) BMI > 30
- Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
- On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
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 |
|---|---|---|
| Sahastara remedy extractAlso: SHT extractThe concentration of SHT extract is 100 mg per capsule | Drug | 25 mg dicolfenac |
| DiclofenacDiclofenac sodium, 25 mg enteric-coated tablets | Drug | 100 mg SHT extract |
Primary outcome
Pain score 1
Time frame: 28 day
Pain score from Visual analog scale
1 secondary outcome
Pain score 2
Time frame: 28 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Associate Professor Arunporn Itharat, Ph.D. study director
faculty of Medicine, Thammasat University
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 Sahastara remedy extract and Diclofenac in people with Osteoarthritis, run by Mr NARIN KAKATUM 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 3 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mr.NARIN KAKATUM (0667867161, narin.ka@ssru.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score 1 (time frame: 28 day). 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 19 Oct 2020.