TINGKAT KEAMANAN FORMULA EKSTRAK DAUN LEGUNDI (Vitex trifolia L) DAN RIMPANG TEMULAWAK (Curcuma xanthorrhiza Roxb) SEBAGAI ANTIALERGI PADA SUBYEK SEHAT
The effect of extract combination of legundi (Vitex trifolia L) leaves and temulawak (Curcuma xanthorrhiza Roxb) rhizomes was investigated preclinically as anti allergy. This formula have been proven relatively non-toxic. Based on these preliminary studies, this formula was then studied in phase I c...
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| Main Authors: | , |
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| Format: | Theses and Dissertations NonPeerReviewed |
| Published: |
[Yogyakarta] : Universitas Gadjah Mada
2011
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| Subjects: | |
| Online Access: | https://repository.ugm.ac.id/90122/ http://etd.ugm.ac.id/index.php?mod=penelitian_detail&sub=PenelitianDetail&act=view&typ=html&buku_id=52468 |
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| Institution: | Universitas Gadjah Mada |
| Summary: | The effect of extract combination of legundi (Vitex trifolia L) leaves and
temulawak (Curcuma xanthorrhiza Roxb) rhizomes was investigated preclinically
as anti allergy. This formula have been proven relatively non-toxic. Based on
these preliminary studies, this formula was then studied in phase I clinical trials to
determine the safety and tolerability of the extract in healthy volunteers.The trial
was designed as randomized and double blind study with 30 healthy volunteers
divided into 3 groups. Each participants in group 1, 2, and 3 received extract
combination of legundi leaves and temulawak rhizomes with the dose of 1500
mg/day, 4500 mg/day, and 9000 mg/day, respectively. Drugs will be administered
orally three times daily for 14 days. The primary outcome measured were the
absence of tolerability and side effects. The secondary outcome measured were
value changes in renal, liver function and physical examination before and after
drug administration (pre and post control group design).
The results showed that the extract combination at the dose of 1500 mg/day
and 4500 mg/day were well tolerated and safe, as seen from the absence of the
drug-induced changes in the renal and liver function. However, there were
significant changes in the value of AST and serum creatinine after administration
of the extract combination with the dose of 9000 mg/day (p <0.05). There were no
significant side effects in the Group 1 and 2, while the thrush and decrease of
blood pressure were reported with administration of the doses of 9000 mg/day.
Thus, extract combination of legundi leaves and temulawak rhizomes at the dose
of 1500 mg/day and 4500 m /day were found to be well safe. |
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