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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20171213003 |
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Date of registration:
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13/12/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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EFFECTS OF PEARL GRASS EXTRACT CAPSULES ON OSTEOARTHRITIS SUBJECT
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Scientific title:
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EFFECTS OF PEARL GRASS EXTRACT CAPSULES ON OSTEOARTHRITIS SUBJECT |
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Date of first enrolment:
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01/08/2016 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20171213003 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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anton -
Bahtiar |
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Address:
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Komplek Timah Kelapa Dua Blok CC no 57
16951
Depok
Indonesia |
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Telephone:
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+6281802225927 |
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Email:
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anton.bahtiar@farmasi.ui.ac.id |
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Affiliation:
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Faculty of Pharmacy, Universitas Indonesia |
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Name:
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anton -
Bahtiar |
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Address:
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Komplek Timah Kelapa Dua Blok CC no 57
16951
Depok
Indonesia |
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Telephone:
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+6281802225927 |
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Email:
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anton.bahtiar@farmasi.ui.ac.id |
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Affiliation:
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Faculty of Pharmacy, Universitas Indonesia |
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Key inclusion & exclusion criteria
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Inclusion criteria: We enrolled healthy non-smoking people aged 50 to 70 years.
Exclusion criteria: We excluded patients who have one or more the conditions as follow: any herbal medicine supplements, consumption of ≥2 alcoholic drinks per day. The subject who have allergy or intolerance to herbal, hormone replacement therapy (HRT) or hormonal contraception in the preceding six months before the pre-randomization visit. Women with systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg, or treated with antihypertensive medications excluded.
Age minimum:
50 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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At the randomization visit, participants randomly assigned to either Placebo or Pearl grass extract capsules. The randomization schedule prepared at Primary care group center.
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Between July 2016 and December 2016, we enrolled healthy non-smoking people aged 50 to 70 years.
We excluded patients who have one or more the conditions as follow: any herbal medicine supplements
At the randomization visit, participants randomly assigned to either Placebo or Pearl grass extract capsules. The randomization schedule prepared at Primary care group center.
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Intervention(s)
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Placebo,Pearl Grass Capsule
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Placebo,Sample tobe evaluated
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Sham Comparator No treatment,Experimental Drug
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Primary Outcome(s)
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WOMAC percentage questionnaire
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Secondary Outcome(s)
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VAS score question
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Source(s) of Monetary Support
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Ministry of Research, Technology and higher education of Indonesia
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
humas@fk.ui.ac.id
The Ethics Committe of Faculty of Medicine Universitas Indonesia
+62213912477 Ext.
humas@fk.ui.ac.id
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Results
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Results available:
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Date Posted:
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Date Completed:
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01/07/2017 |
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URL:
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