Crila capsule honoring Vietnamese pharmacists and medicinal herbs

04/11/2013

The more extensive enquiry into Dr. Nguyen Thi Ngoc Tram’s successful researching and manufacturing process of Crila capsule from Crinum latifolium L. I make, the deeper feeling about the intelligence and enthusiasm of a pharmacist I have; the more respectful about precious herbal treasure of Vietnam. It is said generally that Crila is the honour of Vietnamese pharmacists and medicinal herbs…

15 years of research to invent the first new medicine in the world for benign prostatic hyperplasia and uterine fibroids from Vietnamese medicinal herbs, Dr. Nguyen Thi Ngoc Tram has finished a huge workload.

From a lot of journey throughout the country to search Crinum latifolium L. in Hue, it has experienced research of distinct genetic characteristic (DNA), botanically morphological features and chemical composition to be defined as unique species in 7 varieties of Crinum latifolium L. to have biological activities preventing the growth of tumour cells and stimulating immune system used as materials for manufacturing medicines treating tumours named Crinum latifolium L. var. crilae Tram & Khanh belonging to Amaryllidaceae family by Dr. Tram and Prof. Dr in Science Tran Cong Khanh. It isn’t easy to discover a wild medicinal plant but it’s harder to domesticate it into safe medicinal plant under “Good Agricultural and Collection Practices” (GACP-WHO). Based on the research results of multiplication with natural method, asexual multiplication, cultivation process and scientific caring and collection, Crinum latifolium L. is currently domesticated and grown stably at pharmaceutical material plantation of 30ha in Long Thanh. This medicinal material plantation is far away from main roads, residential area, factories, hospitals and cemeteries to avoid the pollution. This plantation uses water meeting the national technical standard of running water (QCVN01: 2009 issued by Department of Health). No chemical fertilizers are accepted but naturally-decomposed cow manure. Caterpillars are caught by hands or pheromone – a substance having the same scent as female caterpillars. Crinum latifolium L. leaves are materials to produce Crila capsule, which are harvested at the right time with highest content of bioactive alkaloids. Therefore, the content of bioactive alkaloids in extract from Crinum latifolium L. reaches from 0.42 to 0.65%. In order to have materials for manufacturing Crila, Dr. Tram has completed the extracting process of alkaloids -bioactive substances to treat benign prostatic hyperplasia and uterine fibroids. During the extracting process of alkaloids, she perform the technology to eliminate impurities  and substances having unexpected effects such as hippadine – a substance influencing male’s sexual ability. To formulate safe Crila capsule with high treatment efficacy, she has to focus on researching and completing formulation process, study of pharmacological toxicity, stability and standardization of products.

Having completed the entire process from searching for wild herbal plants, domestication, cultivation, extraction and production of new herbal medicine for incurable diseases in humans, Pharmacist – Dr. Nguyen Thi Ngoc Tram has received efficient cooperation from medical scientists. The most typical is Prof. Dr Tran Duc Tho (Former Director of Gerontology Institute, Bach Mai Hospital) – the chairman of subject ‘Evaluation of the treatment efficacy of Crila capsule from Crinum latifolium L. on benign prostatic hyperplasia’. Clinical trials were performed at Central Gerontology Hospital, Central Traditional Medical Hospital and HCMC Hospital of Traditional Medicine, the results showed that Crila capsule can reduce 33-93% of urinary symptoms. 90% patients had their prostate size reduced, some others backed to normal size and got urination organ healthy after 2 months of therapy. With the treatment efficacy at 89.18%, Crila and Crila® Forte are licensed to circulate nationwide by Drug Administration of Vietnam - the Ministry of Health.
Since the Ministry of Health allowed Crila to circulate nationwide in 2005, the product with high treatment efficacy has been trusted due to its low price suitable for low-income laborers. The treatment cost with Crila is only 1/5 to 1/10 compared with imported products for benign prostatic hyperplasia and 1/20 with products for uterine fibroids. Crila has not only lower price but also higher treatment efficacy than imported products. Thanks to Crila’s preeminence, FDA (the USA) allowed it to penetrate into American market in 2011, which makes great contribution to the assessment of product’s potential and quality. It isn’t easy to penetrate into American market. Even though Crila capsule is only recognized as a supplement and needs more clinic trials to be recognized as a medicine in America.

Assoc. Prof. Dr. Vuong Tien Hoa (Central Maternity Hospital) – performed the ministry-level scientific subject ‘Assessment of treatment effect and acceptability of Crila on uterine fibroids’. The results showed the medicine has good efficacy at 79.5% (especially, Crila capsule has high efficacy on uterine fibroids with size from 6cm and below). The medicine has high safety without side effects. The Council of Science agreed to suggest that Ministry of Health add the second indication for uterine fibroids.

Nowadays, Thien Duoc Co., Ltd is a scientific and technological enterprise directed by Dr. Nguyen Thi Ngoc Tram, where manufactures 4 products from Vietnamese Crinum latifolium L. – Crila capsule, Crila® Forte capsule, Crillin supplement and Crinum latifolium L. teabag. The company’s factory is certified under “Good Manufacture Practices” (GMP-WHO), “Good Laboratory Practices” (GLP) and “Good Storage Practices” (GSP) by the Ministry of Health.

Crila and Crila® Forte are not only accepted by domestic pharmaceutical market but also exported to America from 2011.

Crinum latifolium L. var. crilae Tram & Khanh plant brought Dr. Nguyen Thi Ngoc Tram Kovalevskaya Award (2006), National Award of Science and Technology (2010), patent for Crila product and copyright on polymorphological study on Crinum latifolium L. varieties (7 varieties) and discovery of distinct genetic characteristics of Crinum latifolium L. in Vietnam used as materials to produce Crila capsule. In our conversation about Crinum latifolium L. var. crilae Tram & Khanh’s future, Dr. Nguyen Thi Ngoc Tram shared that as soon as she had co-operated with scientists in Bulgarian Academy of Science (since 1990) and University of Innsbruck - Austria (1996) to demonstrate its biological activities to inhibit the growth of tumor cells, cytotoxic effect on lung cancer, liver cancer and pericardia cancer, she put her trust in this precious Vietnamese herb. Its treatment results encourage her to continue further studies to prove its effects in supporting cancer patients, stimulating immune system, enhancing body resistance, inhibiting cell division, stimulating the proliferation and activation of T-lymphocytes. Those effects of alkaloid and flavonoid fractions extracted from Crinum latifolium L. leaves and flowers make great contribution to inhibiting the growth of cancer cells and metastasis after operation.

She added that in the near future, Thien Duoc Co., Ltd would invent Thien Hoang Sa product “a grain of gold sand sifted from Vietnamese herbs” as her speech.