NAME: Melissa O.
Pelegrin
Section: BSP 2B
LAGUNDI
DEFINITION OF LAGUNDI
Lagundi (Vitex negundo) is a herb that has been used in folk medicine as well as for food.
Lagundi has been used in a variety of treatments due to its Phyto-constituent content. According
to specific areas or communities, it has been used in Ayurveda and Chinese medicine. As a
result, it has several names; in Batad (Ifugao province, Philippines), a small indigenous village in
the middle of rice terraces, this plant is known as Dabtan, and it grows wild in this extremely
biodiverse environment. Some people in Ilokos province call it Dangla. In a more urban setting,
small farmer groups, often supported by the church, work to preserve traditional plants.
Vitex negundo is a multi-branched shrub that can grow to be 5 meters tall or a small, slender tree
with thin, gray bark. Flowers are bluish-purple, small, in peduncled cymes, forming large,
terminal, often compound, pyramidal panicles. The fruit is a succulent drupe that is black when
ripe, measures 5-6 millimeters in diameter, and has four seeds. The seeds are oblong in shape. In
the field, seedlings aged four to six months are transplanted. It is easily reproduced from shoot
cuttings. Vitex negundo roots are deep and strong, and it suckers profusely. It produces root
suckers that can be used as planting material. It is planted between June and September and
grows for two years. It has a pungent, bitter, and astringent flavor. It has been used as a hedge,
ornamental plant, agricultural growth promoter, manure, pesticide, medicine, food, food
protectant, household pesticide, in wasteland and erosion reclamation, basketry, witchcraft,
totems, water divination, and in the preparation of grain and garlic storage structures.
Vitex negundo has been used for a wide range of purposes throughout history. It is occasionally
used as a condiment, such as a pepper substitute, as a seed. It can be ground into a powder and
used as flour after being washed to remove the bitterness. The roots and leaves are used to make
a tea/decoction. This decoction can also be used to make alcoholic extracts.
HOW IS LAGUNDI BEING DISCOVERED?
Lagundi has been utilized for generations by local populations in the Philippines for its medical
benefits, but these were not recorded in detail until a book published in 1900 by Spanish Jesuit
Father Colin. Ascof Lagundi, the country's first herbal drug, was introduced by PascualLab in
1996. It was the first herbal drug approved by the Department of Science and Technology and
the Philippine Council for Health and Research Development. It is currently the country's most
successful phytomedicine. Lagundi, formally known as Vitex negundo, is a huge natural shrub
found and growing across Asia and Southeast Asia, including the Philippines and India. Filipino
mothers would boil newly selected green leaves and strain them to make a herbal tea, which
would then be administered to a sick family member. PascualLab introduced the country's first
herbal medicine, Ascof Lagundi, in 1996. It was the first herbal drug approved by the DoST and
the Philippine Council for Health and Research Development. It is currently the most successful
phytomedicine in the country. Lagundi, formally known as Vitex negundo, is a huge natural
shrub discovered and growing in Asia and Southeast Asia such as the Philippines and India.
Filipino moms would boil newly selected green leaves and strain them to make a herbal tea,
which would then be administered to a sick member of the family.
ESTIMATING DRUG’S SAFETY, EFFICACY, EVALUATION AND
PHARMACOKINETICS OF LAGUNDI
Cough frequency was reduced by 44-71% in studies utilizing lagundi syrup. Lagundi treatment
provides a broncho-dilating effect and reduces the frequency and duration of coughing in
pediatric patients with mild to moderate severity, with no major side effects. With these
encouraging results in hand, NIRPROMP created a lagundi-based cough treatment in tablet form
and began clinical studies in the late 1980s, enrolling 119 patients with mild to moderate cough.
DRUG TARGET AND TOOLS FOR PRE-CLINICAL DEVELOPMENT OF LAGUNDI
The development of modern lagundi-based medicine was the product of NIRPROMP's continual
herbal medicine research and development (R&D). R&D was led by UPM researchers,
particularly Dr. Nelia Maramba and Dr. Conrado Dayrit, and focused on clinically validating
traditional medicine, such as lagundi, for use in the development of symptomatic medications
(treatment that focuses on the symptoms of an ailment, not the cause).
ROLE OF GENOMICS AND PROTEOMICS IN DRUG DISCOVERY OF LAGUNDI
Genomics and proteomics are powerful tools for observing and detecting changes in protein
expression in disease and therapeutic treatment, and they can help with both target identification
and validation. Lagundi (Vitex negundo) is an erect, branching tree or shrub that can reach a
height of 5 m. Lagundi has a single thick, woody stem that looks like a trunk and is found in
marshes in the Philippines and India. Lagundi leaves are palmate, with five-pointed leaves that
splay out like a hand's fingers. According to certain research, lagundi can inhibit the body from
producing leukotrienes, which are released during an asthma attack. Chrysoplenol D is a
chemical that has anti-histamine and anti-inflammatory actions. Because histamine can constrict
the bronchial tubes and inflammation of mucus membranes can induce wheezing, these effects
can aid asthmatics.
COMPOUND SELECTION AND PRE-CLINICAL STUDIES OF LAGUNDI
Despite the successful commercialization of the lagundi cough medication formulation, early
market penetration was problematic. Medical professionals and some members of the general
public did not perceive herbal medicine to be an effective type of medical care at the time.
Pascual started a marketing campaign to promote the image of herbal therapies and lagundi
cough remedy to address this issue. The company's first tactic was to promote the medicine
directly to medical practitioners, particularly those at Rural Health Units (RHUs).
IMPACT OF TRANSLATIONAL RESEARCH OF LAGUNDI
When compared to the placebo, Lagundi increased the peak exploratory flow rate (PEFR) at the
end of therapy, however this was not statistically significant (p=0.36). The rise in PEFR was
consistent with the findings of mechanistic isolated tissue investigations that revealed lagundi's
broncho-dilating impact.
CLINICAL STRATEGY OF LAGUNDI
The company's first tactic was to promote the medicine directly to medical practitioners,
particularly those at Rural Health Units (RHUs). RHUs are small government-funded clinics in
rural areas, and as such, they were eager to employ lagundi cough treatment because it was
created as part of a government-funded program. Pascual submitted the medicine to the World
Exposition of Innovative Products, Inventions, and Techniques in Geneva, Switzerland, in 1997,
to further validate its efficacy, and it was granted the silver certificate for R&D. The corporation
brought this award back home and used it widely in advertising and raising awareness, which
helped shift the perceptions of medical professionals and skeptics alike.
ROLE OF FDA IN THE PROCESS OF LAGUNDI
The FDA analyzes adverse event reports provided by dietary supplement producers, health care
providers, and customers, as well as other product complaints, for vital information on product
safety once they are on the market. The FDA-approved Lagundi product, developed under the
National Integrated Research Program on Medicinal Plants (NIRPROMP), has long been used
for cough and asthma relief. It is important to note that herbal supplements are not regulated by
the FDA and, as a result, have not been tested in an FDA-approved clinical trial to prove their
effectiveness in the treatment or management of medical conditions.
FORMULATION DEVELOPMENT AND MANUFACTURING OF LAGUNDI
NIRPROMP created a lagundi-derived formula for a clinically validated cough and asthma
treatment in tablet and syrup form after successfully scientifically identifying the medicinal
characteristics of each section of the plant.
START-UP ACTIVITIES OR THE CLINICAL STUDY OF LAGUNDI
The second phase of the trial discovered that Lagundi is beneficial in reducing minor COVID-19
symptoms, particularly anosmia (loss of sense of smell), as well as providing overall relief from
other symptoms. During the intervention, no notable adverse events or incidences were recorded.
THE PHASES OF LAGUNDI TO TEST ITS EFFECTIVENESS
At the time of the clinical studies, only a few medications, including remdesivir (3), barticinib,
and tocilizumab (4), had been granted emergency use licenses for use in patients with severe to
critical COVID-19 symptoms. Due to the high demand for these drugs, a supply deficit is
unavoidable. This could be avoided with early therapy.
The clinical trials were carried out to examine the efficacy and safety of the Lagundi formulation
developed by the National Integrated Research Program on Medicinal Plants (NIRPROMP) as an
early treatment for patients with mild COVID-19 infection. Hospitalizations might be avoided by
treating symptoms as soon as they appear, and further spread could be minimized by minimizing
the length of infectiousness. From July 2020 to August 2021, a two-stage, randomized, double-
blind, placebo-controlled trial was carried out. The study's subjects were all healthy people with
no comorbidities.
The first step of the experiment was to determine the appropriate dosage of the standard
formulation to be used. The first phase of the study included 75 persons who tested positive for
COVID-19 after rtPCR tests. During 10 days, patients were divided into groups and given either
the usual dose (600mg, three times a day) or the high dose (1.2g, three times a day) of Lagundi
syrup or tablet.
The standard dose was chosen for use in the second phase of the trial since results from the first
phase demonstrated that both dosages are safe and effective in terms of clinical recovery time,
global evaluation scale, and modified early warning score.
The placebo-controlled research was used in the second stage to confirm the dosage's safety and
efficacy. The second phase of the trial involved 200 COVID-19-positive people, who were
divided into two groups: those who got Lagundi treatment (101 patients) and those who received
a placebo (99)
PHARMACOECONOMICS IN DRUG DEVELOPMENT OF LAGUNDI
Last year, two local enterprises sold P1 billion in lagundi capsules and syrup as cough therapy,
demonstrating economic success for companies that have implemented Department of Science
and Technology-funded and supported research and development programs.
According to DOST Assistant Secretary Raymond Liboro, they have been informed that Pascual
Laboratories and United Laboratories, two local firms that adopted and launched the herbal
medicine developed by the Philippine Council for Health Research and Development (PCHRD),
have enjoyed brisk sales for their lagundi capsule and syrup brands.
Liboro stated that the University of the Philippines-Manila, which developed the technology for
lagundi capsules and syrup, would receive a three percent royalty on the invention.
NEW DRUG APPLICATION FILLING AND PRODUCT LABELLING
Another critical requirement is the harmonization of the herbal medicine market for the industry,
health providers, and consumers (Mahady 2001). Herbal medications are commonly offered as
food supplements, but no consistent regulatory framework exists across nations. As a result, the
traditional experience accessible in each location influences knowledge of clinical indications for
their usage, efficacy, and safety. This section provides a quick overview of the legislation in the
United States, Canada, and Europe, which could be used to advise the legal elements of the
herbal medicine industry in other nations. However, a dietary supplement manufacturer or
distributor who manufactures or distributes a supplement containing a "new dietary ingredient,"
that is, an ingredient that was not marketed in the United States prior to October 1994, may be
required to go through a premarket review for safety data and other information. Furthermore, all
domestic and foreign enterprises that produce package labels or store dietary supplements must
adhere to the FDA's current good manufacturing practice (GMP) rules, which establish methods
for ensuring the quality of supplements intended for sale (FDA 2010; Gao 2010).
DRUG COMMERCIALIZATION OF LAGUNDI
Through numerous initiatives to support traditional medicine research and development, Lagundi
has become one of the most established and extensively used herbal cough medicines in the
country. In 1995, PCHRD licensed the lagundi-based drug to three pharmaceutical companies:
Pascual Laboratories, Inc., Gruppo Medica, Inc., and Natrapharm, Inc.
Pascual Laboratories, which launched Lagundi on the market under the brand name Ascof
Lagundi, has completely commercialized the technology since 1997. In 2012, PCHRD
transferred the technology entitlement to UP Manila on behalf of the National Integrated
Research Program on Medicinal Plants (NIRPROMP) in compliance with the Technology
Transfer Act of 2009.
THE VALUE OF MARKETING RESEARCH OF LAGUNDI
NIRPROMP created a lagundi-derived formula for a clinically validated cough and asthma
treatment in tablet and syrup form after successfully scientifically identifying the medicinal
characteristics of each section of the plant. The plant, known as lagundi in the Philippines, grows
in both humid and desert places throughout Africa and Asia and has been used for hundreds of
years by local populations to effectively heal wounds, headaches, ulcers, skin illnesses, diarrhea,
and the common cold, among many others.
CONCLUSION
After successfully scientifically determining the therapeutic properties of each section of the
plant, NIRPROMP developed a lagundi-derived formula for a clinically certified cough and
asthma medication in tablet and syrup form. The plant, known as lagundi in the Philippines,
grows in both humid and desert areas of Africa and Asia and has been used for hundreds of years
by local populations to effectively heal wounds, headaches, ulcers, skin disorders, diarrhea, and
the common cold, among other ailments.
NIRPROMP developed a lagundi-derived compound for a clinically validated cough and asthma
medication in tablet and syrup form after successfully scientifically identifying the therapeutic
properties of each portion of the plant. The plant, known as lagundi in the Philippines, grows in
both humid and desert environments throughout Africa and Asia and has been used for hundreds
of years by indigenous populations to effectively heal wounds, headaches, ulcers, skin disorders,
diarrhea, and the common cold, among many others.
Lagundi is a shrub native to the Philippines. It is a herbal remedy that is used to treat coughs,
colds, and other common respiratory diseases. Lagundi has been demonstrated in studies to
inhibit the body from producing Leukotines, which are generated during an asthma attack.
The plant's antitussive and anti-inflammatory qualities are used in modern medicine. Lagundi's
antitussive and anti-asthmatic properties are due to its anti-inflammatory activity.
Not only is the plant itself helpful, but every portion of it is used in the field of medicine.
REFERENCES:
https://www.bartleby.com/essay/Advantages-And-Disadvantages-Of-Lagundi-PCEPV8AQ3G
https://www.hindawi.com/journals/ijg/2018/9468912/
https://www.wipo.int/ipadvantage/en/details.jsp?id=3661
https://www.google.com/search?
q=ROLE+OF+FDA+IN+THE+PROCESS+OF+LAGUNDI+&ei=L8oNZObIG5vf2roPp_
https://www.pchrd.dost.gov.ph/covid_19_updates/clinical-trials-reveal-lagundi-could-be-used-
for-mild-covid-19/
https://www.ncbi.nlm.nih.gov/books/NBK92773/
https://www.pchrd.dost.gov.ph/heartnovation/lagundi-anti-cough-and-anti-asthma-medicine/
