Crinum latifolium L.: Standardization of medicinal material production for the enhancement of treatment efficacy

08/01/2013

With high treatment efficacy proved through clinical trials at large hospitals, Crila from Crinum latifolium L. was licensed for nationwide circulation in 2005 with the indication for treating BPH and for uterine fibroids. CRILA medicine has been tested and confirmed to satisfy safety standards by Eurofins to enter American market.
 

Choosing right medicinal plant

Nowadays, there are many products advertised to be from Crinum latifolium L. in combination with other medicinal herbs supporting tumor treatment. However, the majority of these products are just supplements having no scientific basis to demonstrate whether the source of materials is safe or whether from the correct Crinum latifolium L. Pharmacist – Dr. Nguyen Thi Ngoc Tram – the person spending over 20 years of her whole life on pursuing Crinum latifolium L. plant with the group of research work presented the national award in 2010 said that there are many Crinum plants in Vietnam having the same botanical morphology as Crinum latifolium L. but different in DNA, therefore, it’s very important to choose the correct plant with therapeutic bioactive substances.

After studying some samples of Crinum latifolium L. collected in Vietnam, Dr. Tram and her colleagues have detected one special sample to contain bioactive substances different from others so-called Crinum latifolium L. (not including other Crinum plants). This sample has been selected for cultivation and developed in large-scale to obtain materials for Crila production. It is a new variety of Crinum latifolium L. in Vietnam, named Crinum latifolium L. var. crilae Tram & Khanh. This is a medicinal herb which is studied to manufacture CRILA, absolutely having no combination with other medicinal plants. ‘The combination with some others such as ginseng, Ganoderma lucidum, Gynostemma pentaphyllum, Semen Juglandis, Paeonia veitchii, Panaxnoto ginseng or Curcuma longa powder hasn’t been included in my research, consequently there’s no scientific basis to ensure its effects on fibroids,’ Dr. Tram said.

Standardization for safe medicinal material production

Nowadays, many patients and manufacturers still confuse Crinum latifolium L. with white Crinum plant. If they buy materials without clear origin on the market, this will result in low-quality products, causing harm to consumers’ health. To create safe and effective capsules, performing quality control of material production under GACP-WHO guideline is not only a vital action deciding the survival and development of businesses but also the medical ethics of manufactures for community health.

As for Crila – a safe capsule, ThienDuoc company – the unit receiving technological transfer from Pharmacist - Dr. Nguyen Thi Ngoc Tram – selected 20-ha-Crinum latifolium L. plantation in Long Thanh – Dong Nai dated from 1994 to cultivate, care, collect and store medicinal materials under GACP-WHO guideline. Hence, the materials reach high and stable content of bioactive substances inhibiting the growth of tumor cells and stimulating immune system for medicine production.

Speaking of the reason why she chose the plantation in Long Thanh – Dong Nai, Dr. Tram shared this plantation has dry and hot climate, suitable soil for the plant development. In addition, it is 1km far from main roads, not near factories, hospitals, cemeteries or residence areas to avoid pollution. We use the water meeting national standards of running water QCVN 01: 2009/BYT issued by the Ministry of Health. No chemical fertilizers, growth stimulants or pesticides are accepted but naturally decomposed cow manure. Caterpillars are caught by hands or pheromone – a synthetic substance having similar structure to the extract from female made and provided by Prof. Dr. in Science Nguyen Cong Hao from Vietnam Institute of Sciences and Technology to lure male caterpillars. Crinum latifolium L. plant is collected when the content of bioactive alkaloid reaches the highest level, then washed under standard water. In order to ensure bioactive substances not to be destroyed in high temperature, ThienDuoc has set up a drying process at proper heat. Based on the evaluation of specialists from the Ministry of Health, on May 20th, 2011 the Drug Administration certified Crinum latifolium L. plantation in Long Thanh – Dong Nai of ThienDuoc Co., Ltd in accordance with ‘Good Agriculture and Collection practices for medicinal plants’ as recommended by World Health Organization (GACP-WHO). This is the first Crinum latifolium L. plantation in Vietnam under GACP-WHO guideline.

Affirming quality – Enhancing treatment efficacy
Apart from standardization of medicinal material source under GACP-WHO, the CRILA manufacturing factory of Thien Duoc company was certified under GMP (Good Manufacture Practices), GLP (Good Laboratory Practices), GSP (Good Storage Practices) criteria by the Drug Administration – the Ministry of Health. This is the foundation for quality product with high treatment efficacy which is proved by clinical trials at leading hospitals including Bach Mai Hospital, Central Hospital of Maternity, Central Institute of Gerontology and Central Hospital of Traditional Medicine. The result showed that after 2 months of Crila therapy, experimental patients got good result at 89.18% for BPH patients and 79.5% for uterine fibroids patients (size not less than 6cm). The medicine has high safety without side effects.
Clinical results at Central Hospital of Traditional Medicine, HCMC Hospital of Traditional Medicine, Hanoi Institute of Gerontology indicated Crila reduced 33-93% symptoms of difficult urination, night urination and 90% patients had their prostate back to normal size, then urinary organ became normal after 2 months of treatment. So far, Crila is the first capsule for uterine fibroids in the world.
Eurofins (USA) has recently published the test result and certified CRILA from Crinum latifolium L. exported to American market as a safe product without known adulterants, GMO or allergens.

(Source: http://eurofins.com/en.aspx)As the direct researcher and discoverer of therapeutic properties of Crinum latifolium L., Dr. Tram recommended consumers to learn about products’ origin to check whether they are from the correct Crinum latifolium L., they are medicines or supplements, where they were undergone clinical trials and their results before using any products from Crinum latifolium L. plant.

Reported by Minh Tri