CSIR-CDRI Lucknow: Phase-III trials of 'Picroliv' drug against Fatty Liver to initiate soon

The CSIR-Central Drug Research Institute in Lucknow has developed a standardised drug 'Picroliv' against Non-Alcoholic Fatty Liver Disease (NAFLD) and it's soon to enter the third phase of clinical trials. As per reports, CSIR-CDRI has received permission to conduct trials among patients of NAFLD, in association with the ICMR, to check its efficacy or side effects. Notably, these clinical trials will be conducted across six hospitals in India, including AIIMS Delhi, ILBS Delhi, PGIMER Chandigarh, KEM Mumbai, NIMS Hyderabad and KGMU Lucknow.

The dire need for NAFLD drug

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In a remarkable feat against the NAFLD 'silent epidemic', the CSIR-CDRI, Lucknow has developed the drug 'Picroliv' from the plant Picrorhiza kurroa (also known as Kutki) under the Phytopharmaceutical mode of Drug Controller General India (DCGI). The new drug may help in the reduction of fat in the liver and its subsequent complications, reversing severe hepatic conditions such as cirrhosis and cancer.

Consequently, there is an increased need for medicinal treatment and this is where CDRI's Picroliv comes into the picture. Earlier, the tests conducted by the CDRI revealed faster recovery and a fall in bilirubin and SGPT levels. On the other hand, the current clinical trial will witness the reduction in fat content of the liver via MRI. The drug will be available after phase-III clinical trial completion for use in society.

What is the Picroliv?

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Picroliv is a Phytopharmaceutical drug and is a standardized extract of Picrorhiza kurroa. With four markers that tested for hepatoprotective effect in animals. As such, the medicine has shown excellent results in animal models of fatty liver, with a reduction in fat deposits and increased secretion of liver enzymes. The drug works with the help of an antioxidant mechanism with additional anti-inflammatory activities and also affects various pathways of fat accumulation in the liver. This product has been approved as a phytopharmaceutical drug by DCGI.

The plant Picrorhiza kurrooa (kutki) used for this is a perennial herb that grows in northwest India, along the Himalayan slope at 3000-5000 meters. For medicinal, large-scale purposes, the plant will be cultivated in the fields of Chamba and Shimla district in Himachal Pradesh, under the authority of CSIR-IHBT Palampur.

Two nodal teams, one from Lucknow, under the leadership of Dr Vivek Bhosale and the other one from Palampur with Dr. Dinesh Sharma, Dr. Amit Kumar as leads will coordinate the product development.

How will be drug benefit individuals with NAFLD?

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Dr. Vivek Bhosale, Medical expert, CSIR-CDRI informed that it is a common condition in obese individuals or people with diabetes. Commonly there are no symptoms, however, there may be some amount of abdominal pain that may be concentrated in the central or right upper part of the abdomen. Patients also experience fatigue and tiredness and even cases of an enlarged liver.

The medicine will be developed as 100 mg capsules, that will target reduction in cholesterol in the Liver and improvement in Liver enzymes. In addition, the drug would require lifestyle changes that are difficult to achieve and sustain by many.