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Ampalaya tablets out soon for diabetics

March 27, 2007 7:22pm
Ampalaya tablets will soon be out in the market as a cure for type 2 diabetes mellitus.

Pascual Laboratories Inc. has secured the license to manufacture, distribute and market a new Ampalaya (bitter gourd) tablet as an anti-diabetic medicine developed by the National Integrated Research Program on Medicinal Plants (NIRPROMP).

Pascual Laboratories has signed the license agreement with the Department of Science and Technology - Philippine Council for Health Research and Development (DOST-PCHRD), which oversees NIRPROMP.

Earlier this month, Health Secretary Francisco Duque has issued a circular reinstating ampalaya (scientific name Momordica charantia Linn. as a scientifically validated herbal medicinal plant that can lower elevated blood sugar levels.

Ampalaya is also known as bitter gourd, or bitter melon. In India, it is known as karela.

With the circular, Duque threw out a circular issued in 2003 by then Health Secretary Manuel Dayrit that classified ampalaya as a “folklorically-validated herbal medicinal plant."

The reclassification came about in view of recent clinical evidence on the efficacy of ampalaya in capsule or tea form as a useful dietary adjunct in the treatment of Type 2 (non-insulin dependent) diabetes.

The DOH cited a 10-year study that found out that the vegetable can effectively regulate blood sugar in the same way as a regular anti-diabetes drug.

Results of the study conducted by the Philippine Council for Health Research and Development (PCHRD) elevated the ampalaya from a mere nutritional supplement to a real medicine.

The study has been certified by the Philippine Institute of Traditional and Alternative Health Care (PITAHC).

"We compared ampalaya leaves with an anti-diabetes drug, and we found out that ampalaya has the same effect on the patient. It means the action of ampalaya on blood sugar is equivalent to the action of the medicine," Dr. Cirilo Galindez, PITAHC director general, said.

The study revealed that a 100 milligram per kilo dose per day is comparable to 2.5 milligrams of the anti-diabetes drug Glibenclamide taken twice per day.

Out in the market soon

The drug manufacturing company said it will soon make the newest locally-produced medicinal drug available in the domestic market after it has been duly registered with the Bureau of Food and Drugs (BFAD).

This new Ampalaya drug will form part of the company’s line of natural diabetes remedies, which currently include Amargozin Ampalaya Capsule.

The drug manufacturer did not disclose yet how much it would be investing in its new Ampalaya tablet project.

The agreement with DOST gives the pharmaceutical company access to the production technology and the clinical studies conducted by Dra. Nelia Maramba, chairperson of NIRPROMP and the UP-PGH Department of Pharmacology, for the Ampalaya drug.

The clinical study undertaken by NIRPROMP showed that the Makiling variety of Ampalaya leaves has the same therapeutic property and action as that of the conventional anti-diabetic drugs.

The Makiling variety of the ampalaya leaves is so far the only clinically-proven Ampalaya for the effective treatment of diabetes, Pascual Laboratories said.

To date, there is no clinical study on the therapeutic efficacy of the Ampalaya fruit and seeds.

The NIRPROMP study on the Makiling variety of Ampalaya leaves served as the scientific evidence for the Department of Health’s reinstatement of Ampalaya as a safe and effective medicinal plant for treatment of Type-2 diabetes (diabetes mellitus).

Pascual Laboratories has an extensive range of ethical and over the counter brands, and has been providing quality medicines to the Filipino people for the past 60 years.


Sampung Halamang Gamot

This restores the place of ampalaya as among the DOH list of Sampung Halamang Gamot (Ten Medicinal Plants).

Other herbal medicinal plants on the list include lagundi (for fever, asthma, headache, toothache, cough and as wound wash and aromatic bath), sambong (for gaseous distention, fever, headache, abscess and as diuretic and aromatic bath), akapulco (as wound wash and for itch), yerba buena (for cough, toothache, headache, dizziness, fainting, hysteria, gaseous distention, arthritis and as mouthwash).

Tsaang gubat (anti-mutility), bawang or garlic (anti-cholesterol), Bayabas or guava (for oral or skin antiseptic), niyog-niyugan (anti-helminthic), and kulasimang bato (anti-pyreruricemia).

In a study, Dr. William D. Torres said Momordica charantia L. fruits, leaves, seeds and other parts, when used as dry powders, extracts, decoctions, fresh or cooled, “has clearly demonstrated hypoglycemic activity in vitro and in vivo."

Dr. Torres is a professor at the Department of Industrial Pharmacy, College of Pharmacy at the University of the Philippines- Manila.

In a separate clinical research, Doctors Reynaldo F. Rosales and Ricardo E. Fernando found that ampalaya fruit, prepared as a tea “is well tolerated and maybe a useful dietary adjunct in the treatment of Type 2 diabetes."

“It has minor gastrointestinal side effects of increased bowel frequency, but beneficial to those diabetic patients who are constipated," said the physicians who are both specialists on diabetes.

“It has no effect ton weight and blood pressure," they added. But for use as an alternative medicine for diabetes, the doctors said further scientific researches may be necessary.

Ampalaya was found containing polypeptide-P, a plant insulin that can lower elevated blood sugar level. Nutritional analysis showed that ampalaya is rich in iron, calcium, and Beta-carotene. It also contains some vitamin B, C, and phosphorous.

Aside from its nutritive value, ampalaya is also used as an emetic, laxative, aphrodisiac and even as abortifacient, according to Doctors Rosales and Fernando.

Dr. Fernando is chief of the section of endocrinology, diabetes and metabolism at St. Luke’s Medical Center in Quezon City. Dr. Rosales is a senior fellow in the same section.

In 2003, various processed ampalaya products flooded the Philippine market causing doubt about its efficacy. Because of this, the DOH had to re-categorize it from being a herbal medicinal plant to a supplement.

Detractors said Dayrit gave in to the influential lobby of multi-national drug companies and other vested interests whose market share were significantly reduced with the popularity of the ampalaya supplementary medicine.

Commendations

The Chamber of Herbal Industries of the Philippines Inc., (CHIPI) promptly commended Duque for the validation of the ampalaya in the light of a global trend towards natural and herbal therapies.

CHIPI is an organization of companies that produce ampalaya products duly approved by the Bureau of Food and Drugs.

The Philippines has one of the world’s richest herbal medicinal resources and ampalaya can be the star herb for the Philippines, much like ginseng is to Korea, CHIPI said.

The group said ampalaya’s global acceptance can spur further research and investment in other herbal resources, which may ultimately help the economy and provide livelihood for many Filipinos.

In a Health Forum organized by the Philippine College of Physicians (PCP) at Annabel’s restaurant in Quezon City, Lito Abelarde, president of the Chamber of Herbal Industries, Inc., said that apart from medicinal use, ampalaya also presents a good potential as a “champion" export product for the Philippines.

Massive production of ampalaya products, he said, would prop up the economy with the job and added income the industry would generate.

Economic benefits

“Ampalaya does not have only health benefits, but also economic benefits," Abelarde said.

Abelarde’s company, Herbcare, has been exporting Charantia capsules and tea to the United States, Canada, Europe, Mexico, Japan, Korea, and parts of the Middle East. He said his company focused on the export market in 2003 when ampalaya was downgraded as a folkloric herbal medicinal plant.

That time, he said 10 of 15 ampalaya herbal brands disappeared from the market, others had to lay off people because many consumers stopped patronizing the product.

Dr. Guia Ciria Abad, immediate past president of the Association of Municipal Health Officers of the Philippines (AMHOP), said she has been actively promoting ampalaya as a supplementary medicine for diabetes since 1981, and even when the DoH reclassified it as a folklorically-validated herbal medicinal plant in 2003.

“Diabetes is a lifetime disease. I come from a family with diabetes. I know that medication is draining the pockets of patients or their relatives. And here’s a supplement that effectively helps control diabetes," she told the media forum.

“We are going down to the level of the barangays, and even down to the households to deliver the information on the health benefits of ampalaya," Dr. Abad said.

“I tell the people, if you don’t have land to plant ampalaya, you can just get a pot or a tin can, plant it by the window and the vines can serve as a curtain. When it bears fruit, you can cook the fruit and the leaves which are nutritious and medicinal," she said.

The physician however advised patients to consult their doctor before stopping the intake of their regular prescribed medicines and just take ampalaya. “Even if you feel good after taking ampalaya, go to your doctor for regular check up and it is up to your doctor to reduce the dosage of your prescribed medicines," she said.

“Ampalaya can be potent, but it can also give you a shock," Dr. Abad warned.

Dr. Cirilo Galindez, executive director of the Philippine Institute of Traditional and Alternative Health Care (PITAHC), said leaves of the Makiling variety of the ampalaya were used in the study. He was quick to point out however that all ampalaya variety, including the ampalayang ligaw or wild ampalaya, have the same basic ingredients that have the same beneficial effects. - GMANews.TV
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