Uji Klinik Obat Herbal

 

Indonesia merupakan negara yang kaya raya dengan potensi sumber daya alam hayati, termasuk tanaman obat. Sebagai negara yang terbentang di daerah tropis dalam hal kepemilikan keanekaragaman hayati tumbuhan obat Indonesia merupakan negara terbesar kedua di dunia, setelah negara Brasil. Sudah sejak lama para leluhur bangsa Indonesia memanfaatkan tanaman obat sebagai sarana untuk menjaga kesehatan dan mencegah penyakit.  Salah satu bentuk obat herbal adalah jamu.

Apakah uji klinik itu?

Uji klinik atau clinical trial adalah penelitian yang dilakukan pada subjek manusia. Umumnya, uji klinis dilakukan pada pasien. Uji klinik atau penelitian eksperimental klinis dibedakan menjadi empat fase, yaitu penelitian klinis fase I, fase II, fase III, dan fase IV.

Jenis penelitian klinis berdasarkan fasenya disajikan pada tabel berikut.

Tabel 1. Fase trial klinik dan karakteristiknya (Bennet & Brown, 2008)

Jenis trial klinik

Tujuan

Metodologi & desain

Fase nol

Penjajakan awal pada manusia untuk senyawa atau agent baru.

Kuasi atau eksperimental historis (pre-post design).

Fase I

Farmakologi  klinik. Dosis aman, tolerabilitas dan profile farmakokinetika, farmakodinamik obat serta pengaruh makanan.

20-80, subjek relawan sehat atau pasien sesuai klas terapi,  trial klinik kuasi atau historic (pre-post study).

Fase II

Eksplorasi efek terapi. Dosis efektif dan rentang dosis aman , keamanan terutama untuk prediksi AE dan profil farmakokinetika, data mekanisme patofisiologi tambahan. Sebelum obat diedarkan.pact of new therapy

30-300, subjek pasien dengan jumlah kecil; open label clinical trial.

Fase III

Konfirmasi efek terapi. Uji efikasi, farmakoekonomi dan keamanan pada jumlah sampel yang cukup dan representative. Sebelum obat mendapatkan izin edar.

250-1000, subjek pasien sesuai dengan criteria inklusi dengan jumlah cukup-besar; RCT parallel atau cross over. 

Fase IV/post marketing surveilans

Evaluasi efek terapi. Pemantauan ADR, tingkat keamanan dan efek/indikasi lain  setelah obat diedarkan.

2000-10.000, subjek: pasien sakit; observasional analitik atau case series.

 

Uji klinik obat herbal adalah pengujian obat herbal pada manusia. Umumnya uji klinik obat dilakukan setelah bakal calon obat sudah menjalani uji praklinik, yang biasanya dilakukan pada hewan uji. Hanya saja untuk uji klinik obat herbal ada dua pendekatan yaitu pendekatan obat herbal sebagai jamu dan obat herbal non-jamu. Pada obat herbal jamu uji klinik bisa dilakukan meskipun tidak melalui uji praklinik. Namun, untuk obat herbal non-prosedur untuk sampai ke uji klinik—sebagaimana pengujian calon obat  pada umumnya, yaitu melalui uji praklinik, uji klinik fase 1, fase 2 , fase 3, dan fase 4.

Uji klinik dilakukan untuk memberikan jaminan kepastian manfaat dan keamanan suatu obat atau obat herbal. Tidak semua obat herbal bebas risiko efek samping sehingga uji klinik ini perlu dilakukan untuk obat herbal demi menghindari adanya bahaya bagi masyarakat. Hanya saja uji klinik membutuhkan sumber daya dan dana yang tidak sedikit.

Universitas Ahmad Dahlan (UAD), Fakultas Farmasi, dengan memanfaatkan dana dari pemerintah juga sudah melakukan uji klinik untuk obat herbal berbahan bunga rosela, tongkat ali, dan jinten hitam.

 Clinical Trial for Herbal Medicine

Indonesia is rich with natural resources potentials including herbal medicine. As a tropical country, Indonesia is the second largest country to produce herbal medicine after Brazil. It has been a long time that our ancestors make use of herbal medicines to maintain their health and cure diseases. One of the form is called jamu.

What is a clinical test?

A clinical trial is a research that is addressed to man as a subject. Generally, this is done to a patient. The clinical trial or also called an experimental research is classified into four phases. i.e. phase I, phase II, phase III, and phase IV. The four phases of clinical trial can be seen in the following table.

Tabel 1. Clinical Trial Phases and Their Characteristics (Bennet & Brown, 2008)

Types of Clinical Trial

Purpose

Methods & Design

Zero Phase

Preliminary study on man about chemical compound and new agent.

Quasi or historical experiment (pre-post design).

Phase I

Clinical Pharmacology. Safe dosage, tolerability and pharmacokinetic profile, medical pharmacodynamics and food effect.

20-80, healthy volunteer subject or patient suitable therapeutic class, historical or quasi trial clinic (pre-post study).

Phase II

Therapeutic effect exploration. Effective dosage and safe dosage range, safety especially to predict AE and pharmacokinetic profile, additional pathophysiology mechanism data, before release of medicine. Pact of new therapy

30-300, little number of patient subject; open label clinical trial.

Phase III

Confirmation of therapeutic effect. Eviction, pharmaco-economy, and safety trial on enough sample and representative before medicine gets legal permit for distribution.

250-1000, suitable patient subject with inclusion criteria with big number; RCT parallel or cross over. 

Phase IV/post marketing surveillance

Therapeutic effect evaluation. ADR, safety  level, and other effect/indication monitoring after medicine distribution

2000-10.000, subject: sick patient; analytical observation or case series.

Herbal medicine-clinical trial is a herbal medicine examination on man. Generally a clinical trial is done after desired prepared medicine undergoes pre-clinical trial, which is applied on animals. Yet, herbal medicine-clinical trial can undergo two approaches i.e. the trial as jamu and non-jamu. For herbal medicine as jamu, the clinical trial can be done without pre-clinical trial. But, for herbal medicine non-jamu to come to clinical trial, it follows the normal procedure i.e. from pre-clinical trial up to clinical trial phase 4.

Clinical trial is done to guarantee the medicine’s advantages as well as safety. Not all herbal medicines are free from side effects so that clinical trial is needed to avoid the danger for public. Nevertheless, clinical trial requires human resources and much fund.

University of Ahmad Dahlan (UAD) through its Pharmacy Faculty made use of government grant to carry out clinical trial for herbal medicine composed of rosela, tonglat ali, and black jinten.

 

Clinical Trial for Herbal Medicine

 

Indonesia is rich with natural resources potentials including herbal medicine. As a tropical country, Indonesia is the second largest country to produce herbal medicine after Brazil. It has been a long time that our ancestors make use of herbal medicines to maintain their health and cure diseases. One of the form is called jamu.

What is a clinical test?

A clinical trial is a research that is addressed to man as a subject. Generally, this is done to a patient. The clinical trial or also called an experimental research is classified into four phases. i.e. phase I, phase II, phase III, and phase IV. The four phases of clinical trial can be seen in the following table.

Tabel 1. Clinical Trial Phases and Their Characteristics (Bennet & Brown, 2008)

Types of Clinical Trial

Purpose

Methods & Design

Zero Phase

Preliminary study on man about chemical compound and new agent.

Quasi or historical experiment (pre-post design).

Phase I

Clinical Pharmacology. Safe dosage, tolerability and pharmacokinetic profile, medical pharmacodynamics and food effect.

20-80, healthy volunteer subject or patient suitable therapeutic class, historical or quasi trial clinic (pre-post study).

Phase II

Therapeutic effect exploration. Effective dosage and safe dosage range, safety especially to predict AE and pharmacokinetic profile, additional pathophysiology mechanism data, before release of medicine. Pact of new therapy

30-300, little number of patient subject; open label clinical trial.

Phase III

Confirmation of therapeutic effect. Eviction, pharmaco-economy, and safety trial on enough sample and representative before medicine gets legal permit for distribution.

250-1000, suitable patient subject with inclusion criteria with big number; RCT parallel or cross over. 

Phase IV/post marketing surveillance

Therapeutic effect evaluation. ADR, safety  level, and other effect/indication monitoring after medicine distribution

2000-10.000, subject: sick patient; analytical observation or case series.

Herbal medicine-clinical trial is a herbal medicine examination on man. Generally a clinical trial is done after desired prepared medicine undergoes pre-clinical trial, which is applied on animals. Yet, herbal medicine-clinical trial can undergo two approaches i.e. the trial as jamu and non-jamu. For herbal medicine as jamu, the clinical trial can be done without pre-clinical trial. But, for herbal medicine non-jamu to come to clinical trial, it follows the normal procedure i.e. from pre-clinical trial up to clinical trial phase 4.

Clinical trial is done to guarantee the medicine’s advantages as well as safety. Not all herbal medicines are free from side effects so that clinical trial is needed to avoid the danger for public. Nevertheless, clinical trial requires human resources and much fund.

University of Ahmad Dahlan (UAD) through its Pharmacy Faculty made use of government grant to carry out clinical trial for herbal medicine composed of rosela, tonglat ali, and black jinten.

Tuhan Tidak Suka Penyair

“Adonis pernah memaparkan kegelisahannya ihwal persinggungan antara sastra dan agama (Islam). Bagi penyair masyhur kelahiran Suriah itu, sastra dan agama adalah dua sisi yang bersihadap. Sastra adalah pertanyaan dan agama adalah jawaban. Pernyataan ini seolah mendapat legitimasi dari al-Qur’an surat asy-Syu’araa yang memaklumatkan ketidaksukaan Tuhan kepada penyair, bahkan menyuruh manusia agar menghindari penyair yang kata-katanya dituntun oleh setan,” kata Shohifur Ridho Ilahi dalam acara Forum Apresiasi Sastra (FAS) #59 dengan tema Sastra dalam al-Quran pada Rabu, (15/6/2016).

Lebih lanjut, Ridho—panggilan akrabnya, mengatakan bahwa pada almanak 13 Februari 1993, dalam wawancara di majalah Tempo, HB Jassin berkumandang, “Tuhan memang tidak suka kepada penyair, kecuali orang yang bertakwa.”

Ungkapan Jassin setidaknya membuka pintu perjumpaan itu bahwa sastra dan agama tidak harus bersihadap-lawankan, tetapi saling bertukar tangkap dengan lepas, mengisi ruang-ruang kosong dan saling melengkapi.

Mengutip dari buku Sastra dan Religiositas (1982), Y.B. Mangunwijaya membuka tulisannya dengan sederhana namun tegas, “Pada awal mula, segala sastra adalah religius.”

Kalimat ini, kata Ridho, telah menjembatani sebuah perjumpaan yang sesungguhnya cukup rumit dipertemukan dan cenderung problematik; sastra (atau seni pada umumnya) dan agama.

Menurut lelaki kelahiran Madura ini, sastra merupakan aktivitas kreatif yang menuntut kebebasan sebagai prasyaratnya, sementara agama cenderung dianggap sebagai kekuatan doktrinal yang abstrak, statis, formalistik, yang berpotensi menghambat tumbuh-kembangnya kreativitas dalam kehidupan sastra.

Acara menarik ini merupakan agenda rutin yang berlangsung di hall kampus II atas bekerja sama dengan Pendidikan Bahasa dan Sastra Indonesia (PBSI) Universitas Ahmad Dahlan (UAD). Acara yang moderator Hairini Nur Hanifah tersebut sekaligus mengadakan buka bersama.

 

God Likes No Poets

‘Adonis once expressed his concern about the relationship between literature and religion (Islam). For the noted poet, who was born in Syria, literature and religion is like a coin’s sides. Literature is a question and religion is the answer. This statement is in accordance with Al-Qur’an Surah Asy-Syu’araa which says that Allah doesn’t like a poet so that He orders man to avoid the poet whose words are under command of Satan,’ said Shohifur Ridho Ilahi in a forum of literature Appreciation (FAS) #59 with the theme literature in Al-Qur’an last Wednesday (15/06/2016)

Furthermore, Ridho – his nickname said that on February 13th, 1993 HB Jassin an interview with Tempo magazine declared, ‘God surely likes no poet except the one who is a believer in God.’

Jassin statement at least opens a possibility of religious meeting in literature – that literature and religion are not contradictory but fills in each other to complete for the perfection.

Quoting the book Sastra dan Religiositas or Literature and Religiousity (1982), Y.B. Mangunwijaya opens his work with a simple but assertive statement, ‘At the beginning all literature is religious,’

‘This statement’ said Ridho ‘has abridged a meeting, which is difficult to understand and tends to be problematic, for literature (or arts in common) and religion.’

According to the Madura born poet, literature is a creative activity, which requires freedom as a prerequisite while religion tends to be doctrinal, abstract, static, and formalistic which is potential to develop creativity sense in the life of arts especially literature.

The interesting discussion is a regular program held at Campus II in cooperation with Indonesian Education Department (PBSI) University of Ahmad Dahlan (UAD). Acting as the moderator was Hairini Nur Hanifah in the last discussion coinciding with ending of fasting together.

Religious Meeting in Poem

‘In a poem, one can feel a religious meeting. Such religious meeting can be found in the works of Hamzah Fansuri, Hamka, Amir Hamzah, Chairil Anwar, A.A. Navis, Kuntowijoyo, Sutarji Coulzum Bachri, Danarto, and Abdul Hadi W.M.’ said Shohifur Ridho Ilahi in a Literature Appreciation Forum (FAS) #59 with the theme Literature in Al-Qur’an last Wednesday (15/06/2016)

‘During 1980s to 1990s writers in Yogyakarta wrote literary works with religious spirits especially Sufism themes involving the new comer writers from UIN (Islamic University) Sunan Kalijaga. One can refer to the book Oposisi Sastra Sufi or Sufism Literary Opposition (2004) written by Aprinus Salam,’ he said.

As a person with poetic talent, Ridho argues that Chairil Anwar’s poem Doa or prayer is a good example of the religious meeting between religion and literature. The two entities amalgamates.

            ‘That is the poet’s, Chairil Anwar, religious culmination as he prays with no regret but appreciation of his love to God with no comparison and cause. Let the breathtakingly beautiful poem closes the discussion in the literature congress. May Allah forgive us,’ he said.


DOA

PRAYER

Tuhanku

dalam termangu

aku masih menyebut namamu

biar susah sungguh

mengingat Kau penuh seluruh

cayaMu panas suci

tinggal kerdip lilin di kelam sunyi

Tuhanku

Aku hilang bentuk

remuk

Tuhanku

aku mengembara di negeri asing

Tuhanku

di pintuMu aku mengetuk

aku tak bisa berpaling

My Lord

in facillation

I still call your name

though difficult it is

recalling You entire all

Your light’s hot sacred

the still lighting kindle in silent darkness

My Lord

I dilute

Crushed

My Lord

I am stranded in a strange land

My Lord

at Your door should I knock

I can never turn off

 

 

 

 

 

Perjumpaan Religiusitas dalam Puisi

“Dalam puisi, kita dapat mengalami perjumpaan religiusitas. Perjumpaan-perjumpaan itu, terdapat pada karya-karya Hamzah Fansuri, Hamka, Amir Hamzah, Chairil Anwar, AA. Navis, Kuntowijoyo, Sutardji Coulzum Bachri, Danarto, dan Abdul Hadi WM,” ucap Shohifur Ridho Ilahi dalam acara Forum Apresiasi Sastra (FAS) #59 dengan tema Sastra dalam al-Qur’an pada Rabu, (15/6/2016).

“Di Yogyakarta sendiri, pada tahun-tahun 1980-an hingga 1990-an, karya-karya yang mengambil spirit religiusitas dengan tema-tema sufisme juga semarak, terutama penyair-penyair yang lahir dan tumbuh di lingkaran kampus UIN Sunan Kalijaga. Untuk yang disebut terakhir, sidang musyawarah bisa melacaknya di buku Oposisi Sastra Sufi (2004) anggitan Aprinus Salam,” terangnya.

            Sebagai orang yang bersinggungan dengan puisi, Ridho berpendapat bahwa puisi “Doa” karya Chairil Anwar adalah salah satu contoh perjumpaan yang intim antara agama dan sastra. Dua entitas itu lebur dan menyatu.

“Itu adalah salah satu puncak religiusitas seorang Chairil yang berdoa tanpa ratapan dan menghayati cinta kepada Tuhan tanpa umpama, tanpa sebab atau karena. Dan biarkan puisi yang mengharu biru ini menutup catatan kecil pada musyawarah sastra kali ini. Semoga Allah memaafkan saya,” ucapnya.

 

DOA

 

Tuhanku

dalam termangu

aku masih menyebut namaMu

 

biar susah sungguh

mengingat Kau penuh seluruh

 

cayaMu panas suci

tinggal kerdip lilin di kelam sunyi

 

Tuhanku

aku hilang bentuk

remuk

 

Tuhanku

aku mengembara di negeri asing

 

Tuhanku

di pintuMu aku mengetuk

aku tidak bisa berpaling

 

Mahasiswa PBSI Menjadi Pemakalah Seminar Nasional

Wacana tentang sastra anak ditanggapi dengan serius oleh mahasiswa semester delapan Prodi Pendidikan Bahasa dan Sastra Indonesia (PBSI), Setiyono. Kepeduliannya terhadap sastra anak membawanya menjadi satu dari 64 pemakalah dalam Seminar Nasional Sastra Anak Himpunan Sarjana Kesusastraan Indonesia (HISKI) 2016. Acara yang digelar di Balai Bahasa Yogyakarta pada Sabtu, (28/5/2016) itu banyak diikuti oleh guru-guru se-DIY.

Mahasiswa yang aktif berorganisasi di Teater JAB dan Kreativitas Kita ini mengaku mengikuti seleksi pemakalah karena ingin mencari pengalaman terkait dengan sastra anak. Selain itu, ia juga sedang menyusun skripsi yang konsentrasinya fokus pada sastra anak.

Kendati baru pertama kali menjadi pemakalah dalam seminar tingkat nasional, Setiyono mengaku merasa tertantang dan bangga dapat berpartisipasi walau pun merasa sedikit gugup.

“Saya sangat terbantu oleh pihak prodi dan dosen-dosen yang telah memberikan panduan serta motivasi,” tuturnya saat ditemui di kampus II UAD. Dalam makalahnya, Setiyono menawarkan solusi penggunaan cerita pendek Lebah Lebay di Taman Larangan karya Rina Ratih sebagai alternatif bahan ajar dan mengoptimalkan empat keterampilan dasar berbahasa. (dev)

 

Two PBSI Students Presented Papers in A National Seminar

‘The case of children’s literature has seriously taken into consideration by the eighth semester students of Indonesian Education Department (PBSI),’ Setyono said. His concern on children’s literature has urged him to become one of 64 presenters at 2016 national seminar of Association of Indonesian Literature Scholars (HISKI). The event was held at Yogyakarta Language Office last Saturday (28/06/2016) attended by teachers from all over Yogyakarta.

The student, who takes part in Teater JAB and Kreativitas Kita followed a selection of presenters to get an experience especially the one related to the children’s literature. Moreover he is still writing his under graduate thesis related to children’s literature.

Though this was his first experience as a national presenter, Setyono felt challenged and proud he was able to participate in the event amidst his nervous feeling.

‘I was much helped by the lecturers at the department, who have motivated and guided me,’ he said as he was interviewed at Campus II UAD. In his paper, Setyono suggested that the short story Lebah Lebay di Taman Larangan written by Rina Ratih be used as a teaching material for the teaching of four language skills. (dev)

Dahlan Rais: Perbedaan Sekolah Muhammadiyah dengan Sekolah Negeri

“Apa perbedaan sekolah Muhammadiyah dengan sekolah negeri?”

Begitu pertanyaan seseorang, yang dilontarkan kembali oleh Drs. H. A. Dahlan Rais, M.Hum. saat memberikan ceramah di acara buka bersama Rabu (15/6/2016) di auditorium kampus I Universitas Ahmad Dahlan (UAD).

“Jelas di Muhammadiyah lebih islamiah. Seperti contoh perguruan tinggi UAD yang mengemban visi misi Moral dan Intelektual Integrity,” ucapnya sambil memberikan contoh perguruan tinggi Muhammadiyah yang lain.

Bagi lelaki Solo kelahiran 26 Maret 1951 tersebut, islami berarti perilaku yang didukung oleh instansi, baik sekolah maupun di perguruan tinggi Muhammadiyah. Muhammadiyah adalah Islam yang modern. Islam modern itu mempunyai kriteria bersih, tertib teratur, dan disiplin menepati waktu.

Adik kandung mantan Ketua MPR, Amien Rais, ini menegaskan bahwa tugas Muhammadiyah adalah menegakkan moralitas di tengah-tengah masyarakat global.

“Di Muhammadiyah, bagi mahasiswa baru akan diberikan pelatihan kepemimpinan, darul arqom, selanjutnya akan dibimbing oleh Ikatan Mahasiswa Muhammadiyah (IMM) dan kemuhammadiyahan.”

Di akhir ceramah, ia berharap kepada UAD yang kini tumbuh dengan mantap, agar menjadi perguruan tinggi swasta yang terbaik di Indonesia dan menjadi rujukan di perguruan tinggi lainnya.

 

Dahlan Rais: The Diffeence between State and Muhammadiyah Schools

‘What is the difference between state and Muhammadiyah Schools?’ It was a question, expressed once again by Drs. H.A. Dahlan Rais, M.Hum as he was delivering a speech at the end-fasting event last Wednesday (15/06/2016) at Auditorium Campus I University of Ahmad Dahlan (UAD).

‘Clearly Muhammadiyah is Islamic. As an example is UAD with its mission Moral dan Intellectual Integrity or Moral and Intellectual Integrity,’ he said as mentioning more Muhammadiyah educational institutions.

For the man, who was born in Solo March 26th 1951, being Islamic means the moral conduct, which becomed the basis of the institution. Muhammadiyah is an Islamic modern movement. The criterions of Islamic modern among others are clean, regular orderly, discipline, and on time.

The brother for former House of Representative Speaker Amin Rais reaffirmed that Muhammadiyah strengthens morality amidst global society condition.

‘In Muhammadiyah, the students are trained in leadership, darul arqom and then they are organized in Muhammadiyah University Student Association (IMM) and Muhammadiyah institutions.’

At the end of his speech, he expected that UAD as a growing private university in Indonesia be a leading university and become reference of other universities.