Sahastara Remedy Extract Capsule in Primary Osteoarthritis of Clinical Trial Phase II
NCT ID: NCT04591795
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2018-01-01
2020-10-13
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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100 mg SHT extract
Drug: Sahastara remedy alcoholic extract comparison with diclofenac
Diclofenac
Diclofenac sodium, 25 mg enteric-coated tablets
25 mg dicolfenac
Drug: diclofenac comparison with diclofenac
Sahastara remedy extract
The concentration of SHT extract is 100 mg per capsule
Interventions
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Sahastara remedy extract
The concentration of SHT extract is 100 mg per capsule
Diclofenac
Diclofenac sodium, 25 mg enteric-coated tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Have serious medical condition including Severe peptic ulcer, congestive heart disease, Liver and Renal dysfunction.
* On during use medicine including Rifampicin, Phenytoin, Propranolol, Theophylline
40 Years
70 Years
ALL
Yes
Sponsors
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Mr NARIN KAKATUM
OTHER
Responsible Party
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Mr NARIN KAKATUM
Faculty of Medicine
Principal Investigators
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Associate Professor Arunporn Itharat, Ph.D.
Role: STUDY_DIRECTOR
faculty of Medicine, Thammasat University
Locations
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Mr. NARIN KAKATUM
Bangkok, BKK, Thailand
Countries
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Central Contacts
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Other Identifiers
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MTU-EC-TM-2-116_2/59
Identifier Type: -
Identifier Source: org_study_id
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