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Discovering new values

The scientific research project “Study of the biological effects and safety of alkaloids and flavonoids from Crinum latifolium L. var. crilae Tram & Khanh” through new capsule Crilin® T received an “EXCELLENT” evaluation from the Peer Review Board at the ministerial level acceptance session last December 2014. This is good news for cancer patients.


According to Pharmacist-Dr. Nguyen Thi Ngoc Tram – Director of Thien Duoc Co., Ltd and head of the project “Study of the biological effects and safety of alkaloids and flavonoids from Crinum latifolium L. var. crilae Tram & Khanh”, cancer is a disease challenging many scientists; treatments by chemotherapy, radiotherapy and surgery still have undesirable side effects. These undesirable side effects can affect greatly patient’s health. Scientists around the world have been trying to find out drugs for internal treatment contributing to support the treatment of cancer effectively. Meanwhile, herbal medicines for the treatment of cancer have not yet been found.
 This scientific project was managed and partly funded by the Ministry of Health for a collaboration of scientists from Vietnam and Bulgaria to conduct and develop the protocol between the two countries which has been supported by the Ministry of Science and Technology since 2009. The research project was conducted from 2010 to 2014.  
In Vietnam, there is a very rich source of medicinal herbs and scientists have been trying to find in this source new bioactive substances which have therapeutic effects against cancer. Recently, the Ministry of Science and Technology has implemented a protocol between Vietnam and Bulgaria, followed by the research project “Study of the biological effects and safety of alkaloids and flavonoids from Crinum latifolium L. var. crilae Tram & Khanh” chaired by the Ministry of Health. The project was composed of 3 objectives: Study on the formulation of Crilin® T hard capsules from biologically active alkaloids and flavonoids extracted from the leaves and flowers of Crinum latifolium L. to support the treatment of cancer; Study on the biological effects and safety of alkaloids and flavonoids from Crinum latifolium L. and Crilin® T capsules in which studies of acute toxicity of alkaloids and flavonoids extracted from Crinum latifolium L. and subacute toxicity of Crilin® T were conducted; Studies on the biological effects and evaluation of the ability of Crilin® T to stimulate the immune system against cancer and cytotoxicity.

From these 3 objectives, 6 contents were done: Extraction of alkaloid fractions C1, C2, C3 and flavonoid fraction H1 was conducted in accordance with the process studied in the protocol between Vietnam and Bulgaria; Production of dried extracts from alkaloid fractions C1, C2, C3 and flavonoid fraction H1 and establishing specifications of dried extracts; Studies of pharmacological effects; Studies on formulation and establishing specifications of Crilin® T capsules; Stability studies of Crilin® T; Evaluation of biological effects of Crilin® T capsules formulated from alkaloid fractions C1, C2, C3 and flavonoid fraction H1 extracted from the leaves of Crinum latifolium L.; in vitro and in vivo studies were conducted.

Scientists in the acceptance session

Pharmacist-Dr. Nguyen Thi Ngoc Tram said: “We have innovated technology in cultivation, extraction and formulation to produce a new Vietnamese medicinal herbal product named “Crilin® T” from certain specific alkaloids and flavonoids (tumor growth inhibitory substances) extracted from the leaves and flowers of “Crinum latifolium L. var. crilae Tram & Khanh” (a new proprietary cultivar of Vietnamese Crinum latifolium, with the scientific name Crinum latifolium L.). From these bioactive substances, studies were conducted for safety, toxicity and cytotoxicity, especially concentrating on the biological effects and evaluation of the ability of Crilin® T to stimulate the immune system against cancer”.

As reported by the research project, American BALB/c nude mice (mice without thymus or immune system) were imported for the research project and inoculated with human lung cancer cells, helping the scientists discover several interesting outcomes. After being administered to the highest possible dose, mice from all groups still ate, drank and excreted normally. No mouse died within 72 hours after taking trial drugs and no sign of toxicity was observed during 7 monitoring days.


  This project was presented with 2 patents in 2014 for the research process of cancer treatment medicine Crilin® T. It was also reported in 4 articles of specialized medical publications nationwide and worldwide. In early 2012, the study work group on Crinum latifolium L. by Dr. Tram was awarded the State Prize. 
The research results of “subacute toxicity” of Crilin® T on rabbits have also led to the conclusion that this Vietnamese medicinal herb is safe for patients. Both trial doses do not affect the general health conditions, weight, hematopoietic function, liver function, kidney function and histopathology of liver and kidney of rabbits. Antioxidant and anti-inflammatory properties, among others, are the subject of intense research study in Vietnam and the Bulgarian Academy of Sciences.

The research results showed that Crilin® T has virtually no undesirable side effects, but can stimulate and enhance the immune system in mice.
On this basis, the research group recommended the Ministry of Health to conduct clinical trials on lung and prostate cancer patients to evaluate the treatment efficacy, safety of Crilin® T and its ability to stimulate the immune system against cancer.

    Dr. Tram and the scientists concluded that the findings demonstrated Crilin® T has the ability to support the treatment of cancer. This low-priced medicinal herbal product is not inferior to cancer treatment drugs circulated in domestic and international markets. With new discoveries, Dr. Tram and her colleagues are expected to provide cancer patients with a specific safe and low-priced medicinal herb.


The ministerial level Peer Review Board was very excited and agreed to conclude this research project with an “EXCELLENT” evaluation.
The Peer Review Board concluded that the initial results were very encouraging and formally recommended in vivo clinical trials on lung and prostate cancer patients to further the solid scientific basis for the production of a new Vietnamese medicinal herb for mass production, contributing to patient health care.

    Assoc. Prof. Dr. Nguyen Thi Bich Thu from Vietnam Pharmaceutical Materials Institute said: “The project has applied national and international pure research methods. The results are reliable, meeting and exceeding requirements. Product quality meets criteria set forth. The project is of great scientific significance, compliance with ethical issues of biomedical research. It is highly persuasive, scientifically and practically valuable”.

     Assoc. Prof. Dr. Pham Ngoc Bung from Hanoi Medical University commented: “Research methods and equipment used in the scientific research project are of high reliability and accuracy. The project has been presented carefully and reliably with well-prepared documentation. It has been fully implemented with standardized input materials. Although there was a lot of work to be done, the research group completed the project successfully as scheduled. The product’s quality is of great scientific significance and biological effects. The project has a strong impact on the economy and the society if the product is launched to the market”.

    Assoc. Prof. Dr. Pham Dang Khoa from Hanoi Medical University said: “I found that it was very fantastic when this medicinal herbal product could create immunity in mice absolutely having no immune system. Crilin® T will be an extremely good product, helping to enhance the immunity for patients, especially cancer patients”.

    Assoc. Prof. Dr. Trinh Van Quy from the National Institute of Drug Quality Control said: “This is a very seamless research from herbal materials to extraction into products and then study of biological effects, etc. The research results are good. Clinical trials should be conducted on this product so that it can become medicines”. On this proposal, Assoc. Prof. Dr. Bui Dieu from K Hospital noted: “Clinical trials should be considered for the benefit of patients”.

    Observing the acceptance session, Dr. Tran Thi Oanh from the Department of Science, Technology and Training said: “This is a fully methodical research project. The product should be directed to medicines. I personally think this is an excellent project; the research group gets on well and collaborates professionally with each other”.

    Prof. Dr. Nguyen Minh Duc from HCMC University of Medicine and Pharmacy as the Chairman of the Peer Review Board evaluated: “This is a high quality research project with the close collaboration of scientists at home and abroad. The project was implemented not only in the laboratory but also in large scale that created the product. This research model needs to be replicated in order to contribute to the discovery of Vietnamese pharmaceutical materials’ quality. It can be said that this is a very successful linking model between the state, the scientists and the businesses.

Up to now, in addition to the capsules awaiting permission from the Ministry of Health to conduct clinical trials on voluntary cancer patients, Dr. Tram has studied to produce many medicinal herbal products from Crinum latifolium L. such as Crila®, Crilin®, Crinum latifolium L. tea and some exported to American market. In fact, leaves of the Royal Virgin herb were used as a traditional folk remedy for many diseases. However, there was no research work that could turn this valuable medicinal herb into a modern, commercially available product serving the community. Nearly 20 years ago, Dr. Tram detected Crinum latifolium L. var. crilae Tram & Khanh. Since that time, she resolved to build a large-scale organic herbal material plantation and modern production facility. In July 2005, the first capsules were launched to the market which drew much attention from the public. In 2010, Healing Quest, a famous American television program specializing in integrative health, came to Vietnam to report on Dr. Tram’s research. This inspired scientific circles as well as people around the world to travel to Vietnam to learn more. A year later, Crila® - Dr. Tram’s medicinal herbal products for uterine, menopause and prostate health - officially entered the American market, which is considered the most demanding pharmaceutical market. 



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