Cognium syrup combination rationale

COGNIUM is a herbal combination aimed at preserving and enhancing cognitive

functions. COGNIUM slows down the process of degeneration of neurons through
antioxidants, nervine tonics and by improving circulation. It increases circulation to the
CNS, provides protection to the nervous system by acting as an adaptogenic against
stress. It is also used to promote intelligence, enhance memory and retention, especially
for school-going children. It also curbs agitation and anxiety.

Pharmacological Group: Nootropics & Neurotonics/Neurotrophics.

Benefit to Risk Ratio:

1. Therapeutic Rationale:

Cognium’s Active
English Name Reason for Inclusion Mg/5 ml
Ingredients
Action - Adaptogen,
CNS relaxant,
peripheral vasodilator,
sedative, laxative,
diuretic. Used as a brain
tonic for improving
memory and for
overcoming mental
confusion, stress,
Centella asiatica Gotu Kola fatigue. Total triterpenic 100 mg
fraction of centella
asiatica (TTFCA) tablets
have demonstrated
improvement of venous
hypertension at doses of
30 mg given three times
daily or 60 mg given
three times daily
(Belcaro, 1990).
Herpestis Monniera Water Hyssop Traditionally used as a 70 mg
brain tonic to enhance
memory development,
learning, and
concentration, and to
 provide relief to
patients with anxiety or
epileptic disorders.
Adaptogenic, sedative,
potent nervine tonic,
anti-anxiety agent
(improves mental
functions, used in
insanity, epilepsy). B.
monnieri has been
shown to cause
prolonged elevated
level of cerebral
glutamic acid and a
transient increase in
GABA level. It is
assumed that
endogenous increase in
brain glutamine may be
helpful in the process of
learning.

Cardiotonic and poor

Terminalia arjuna Arjuna coronary circulation. 70 mg
Lowers blood pressure.

Brain tonic, tranquilizer

used in nervine
disorders, mental
aberration, anxiety
neurosis. The
Ayurvedic
Evolvulus Pharmacopoeia of
Morning Glory 70 mg
alsinosides India recommends the
plant for epilepsy. The
plant contains
sankhpushpine
alkaloids. Large doses
cause acute gastro-
intestinal irritation.
Withania somnifera Winter Cherry Root—used as a 70 mg
sedative and hypnotic
in anxiety neurosis.
Withanine—sedative,
hypnotic. Withaferin A
 —major component of
biologically active
steroids; as effective as
hydrocortisone dose for
dose. The root extract
contains an ingredient
which has GABA
mimetic activity. Mood
Stabilizer.
Seeds—nervine and
brain tonic, diaphoretic,
febrifugal, emetic. Seed-
Celastrus paniculatus Staff Tree oil—used for treating 50 mg
mental depression,
hysteria and for
improving memory.
Nervine tonic,
hypotensive,
tranquilizer, sedative
(with neuroleptic and
antianxiety properties),
analgesic, spasmolytic,
Acorus calamus Sweet Flag anticonvulsant; It is 50 mg
used in Ayurveda to
counter the side effects
of all hallucinogens. Dr.
Vasant K. Lad,
Ayurveda: The Science
of Self-Healing
Glycyrrhiza glabra Licorice Soothes the Intestinal 50 mg
tract and improves the
flavor. Licorice is also a
potent antitoxin
lowering the toxicity of
many toxins including
strychnine,
histamine, arsenate,
snake venom,
diphtheria toxin,
tetanus toxin, etc. In
Traditional Chinese
Medicine (TCM) it is
considered to be a
synergist and is used in
 many Classic formulas
as a supporting and
harmonizing agent.
Key application in
dyspepsia such as mild,
spastic, gastrointestinal
Foeniculum vulgare Fennel afflictions, fullness, 25 mg
flatulence. Counteracts
any ill effects caused by
Morning Glory.
Action -Nutmeg—
carminative,
spasmolytic, antiemetic.
Nutmeg is used in
flatulency, diarrhoea,
nausea and vomiting.
Myristica fragrans is a
well known Indian
household spice have
been reported to
possess several
neuropharmacological
properties. Anti-
depressant activity of n-
hexane extracts
involving adrenergic,
dopaminergic and
Myristica fragrans Nutmeg 20 mg
seretonergic system 30.
N-hexane fraction of
acetone insoluble part
of petroleum ether
extract and its acetone
soluble portion is
reported to possess
anticonvulsant,
significant behavioral
effects, anxiogenic,
sedative and
cholinesterase inhibiting
properties 31 indicating
wide spectrum of CNS
effects.
Benefits to Risk Ratio:

Active ingredients, which are in the composition of the syrup, have such actions as:

Important ingredients Action

Nootropic, Cognitive, Neuroprotective,

Morning Glory
Adaptogenic

Gotu Kola & Arjuna Enhance circulation to the CNS

Climbing Staff Tree Cognitive, Nootropic, Nervine

Adaptogenic, Anxiolytic, GABA mimetic

Winter Cherry activity, Mood Stabilizer.

Nootropic, Cognitive, Controls anxiety and

Water Hyssop reduces stress induced forgetfulness,
sedative, nervine, adaptogenic

THERAPEUTIC RATIONALE

COGNIUM tablets and syrup are aimed at preserving and enhancing cognitive
functions. COGNIUM slows down the process of degeneration of neurons through
antioxidants, nervine tonics and by improving circulation. Traditionally, Bacopa
monnieri was used as a brain tonic to enhance memory development, learning, and
concentration and results support the traditional Ayurvedic claims. Bacopa
monnieri and Celastrus paniculatus present in COGNIUM improve cognitive
functions. Bacopa can be used together with Gotu Kola, but in lower dosages.
Centella asiatica and Terminalia arjuna enhance circulation to the CNS. Withania
somnifera and Morning Glory provide protection to nervous system by acting as
adaptogenic against stress. In Unani and Ayurvedic traditional systems, Morning
Glory is used as a nootropic or brain tonic, used for memory loss, nervous debility,
fever, epilepsy and immune disorders. It is also used to promote intelligence,
enhance memory and retention, especially for school-going children. It also curbs
agitation and anxiety and induces peaceful sleep. Arjuna counteracts the effects of
the glycyrrhizin in the Licorice by causing a lowering of blood pressure. The
Glycyrrhiza glabra root component Glycyrrhizin induces potassium excretion in
conjunction with sodium and water re-absorption in the kidneys, resulting in
hypokalemia and hypertension, if used in large amounts for prolonged periods
(Brinker, 2001). But Bacopa extract may be used as a potassium supplement in a
therapy with potassium depleting diuretics (e. g. hydrochlorthiazide). (Herbal
Vade Mecum Gazmend Skenderi 2004 ISBN: 0971320926 Pg. 29). However,
licorice extracts are safer than consuming an equivalent amount of pure
glycyrrhizin, due to modified intestinal absorption and bioavailability of the
glycyrrhizin when it is combined with other licorice components (Cantelli-Fort et al
1994) and these problems become insignificant when licorice root is included as one
of several ingredients in a mixture of herbs (Joseph L. Mayo, MD, FACOG).
Licorice is added to so many mixtures in Chinese medicine as a synergistic agent,
both as a potentiator and detoxifier. These effects are now becoming better
understood, and it is known that licorice potentiates compounds such as
paeoniflorin as a neuromuscular blocking agent, while affecting intestinal
absorption of toxic substances such as the aconite alkaloids (Miaorong and Jing,
1996). Licorice is a potent antitoxin lowering the toxicity of many toxins including
strychnine, histamine, arsenate, snake venom, diphtheria toxin, tetanus toxin, etc.

Safety:

Principles of Drug Formulation

Ayurvedic literature places great emphasis on the pharmaceutical process known

as samskara. Samskara literally means a process. It is designed to enhance the
desirable qualities of the drug being processed. The samskara can be classified into
two stages: (purification or detoxification of toxic substances) and (formulation of a
dosage form). A number of toxic herbal drugs like bhaishajya kalpana, Strychnos
nuxvomica, Aconitum ferox, Semicarpus anacardium, Commiphora mukul, and
almost all metal and mineral drugs are purified and rendered safe for use, before
their use as drugs. Licorice is also a potent antitoxin lowering the toxicity of many
toxins including strychnine, histamine, arsenate, snake venom, diphtheria toxin,
tetanus toxin, etc.

Using Sweet Herbs To Counter Side Effects

A long-standing principle of Chinese medical practice is that sweet-tasting herbs

counter the toxicity and adverse effects of other herbs. Raw licorice root is sweet,
bitter, and neutral, and in the same plant family as sophora (Leguminosae; this is
the family of beans, also called legumes). It is well known for its toxicity-relieving
properties for both hot and cold natured herbs. In the Shoushi Baoyuan (1616 A.D.),
it is said that: "licorice is always employed to dissolve all possible poisonous effects
of drugs (19)." The detoxifying effect of licorice is described this way in the Oriental
Materia Medica (2): "Glycyrrhizin [a major active constituent of licorice] and its
calcium salt possess detoxifying action on bacterial toxins (diphtherin, tetanin),
poisonous foods and drugs, and toxins of metabolic products. Glycyrrhizin, when
degraded, yields glucuronic acid, which in the liver will combine with toxic
materials to form glucuronide to produce a detoxifying action."

2. Therapeutic indications:

Improves memory, learning and cognition in school aged children

Indications:

 Memory and learning disorders associated with:

- Attention fluctuations
- Concentration impairment
- Language and Learning disability

 2) Behavioral disorders associated with:

- Hyperkinetic states

- Asocial behaviour
- Aggressive behaviour
- Temper tantrums
- Enuresis
- Attention-Deficit Hyperactivity Disorder (ADHD)
- Attention-Deficit Disorder (ADD)

 Anxiety and stress related disorders

 Mental fatigue due to stress
 Senile dementia
 As an adjuvant to Alzheimer’s and Parkinson’s disease
 Supportive therapy in mild to moderate mental retardation
 Prophylactic Treatment for some types of childhood epilepsy
3. A. Dosage Regimen:

Adults and Children 12 and over: 10 ml orally, twice daily

Children 9-12: 5 ml orally, twice daily

Children 6-8: 5 ml orally, once daily

Duration: 3-4 months.

B. Route of administration: Oral

Risks:

Side effects.
There is no data involving side effects caused by the preparation.

Adverse Drug Reactions (ADRs)

In clinical trials the drug was well-tolerated and there were no adverse effects. No
adverse effects were reported during the treatment.

Cognium does not contain alcohol, soporific and narcotic agents. Cognium is well
tolerated by all age groups of patients, including children. There is no data involving
side effects caused by the preparation. The addition of actives in any formulation is
generally done as per Ayurvedic principle of VRIDDHI SAMANAHI---,” which means
that medicines with similar properties even though added in less quantity give good
result. Therefore in practice instead of using single drug in therapeutic dosage it is
always preferred to use combination of more than one herb in sub-therapeutic dosage,
this not only provides good result, but also chances of ADR is also substantially
reduced. Raw licorice root is sweet, bitter, and neutral, and in the same plant family as
sophora (Leguminosae; this is the family of beans, also called legumes). It is well known
for its toxicity-relieving properties for both hot and cold natured herbs. In the Shoushi
Baoyuan (1616 A.D.), it is said that: "licorice is always employed to dissolve all
possible poisonous effects of drugs (19)." The detoxifying effect of licorice is
described this way in the Oriental Materia Medica (2): "Glycyrrhizin [a major active
constituent of licorice] and its calcium salt possess detoxifying action on bacterial
toxins (diphtherin, tetanin), poisonous foods and drugs, and toxins of metabolic
products. Glycyrrhizin, when degraded, yields glucuronic acid, which in the liver
will combine with toxic materials to form glucuronide to produce a detoxifying
action."
Polyherbal Formulation - Synergy

Major formulations used in Ayurveda are based on herbs used as decoctions, infusion,
tinctures and powders. Drug formulation in Ayurveda (As mention in Ayurvedic
treatise like Charaka Samhita, Sushruta Samhita) is based on two principles: (a). Use as
single drug, and (b). Use of more than two drugs. When two or more herbs are used in
formulation they are known as polyherbal formulation. The concept of polyherbalism is
peculiar to Ayurveda although it is difficult to explain in term of modern parameters.
Sarandghar Samhita highlights the concept of synergism behind polyherbal
formulations. Licorice has been traditionally used in formulations, not as a single
herb. Licorice taken within the recommended therapeutic dosage range is a very safe
herb.

Contraindication/precautions:

Use only under medical supervision. Use only as directed. Not recommended for
children under 6 years old.

Overdosage:
Symptoms: Drowsiness
Treatment: gastric lavage, activated charcoal, symptomatic therapy,

Drugs interactions:
Cognium may reduce the effectiveness of Phenytoin, Phenobarbitol and other similar
classes of drugs.